MyelinWatch EL

INDEPENDENT RESEARCH MONITOR

Latest important developments

Meaningful changes only — not every new paper or repeated press release.

Newest research events first; the date MyelinWatch published each page is shown separately.

results

Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in Greece; not a result

Phase 3 extension study authorised in Greece; recruitment not yet started

Frexalimab: Greece authorises the long-term Phase 3 extension study

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Greece authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 2 November 2026. Denmark, Portugal and Poland authorised it on the same day, after Belgium (30 October 2026) and Austria (1 November 2026); all six countries are listed as authorised with recruitment pending. The record plans 17 participants in Greece and lists four Greek hospitals: AHEPA University General Hospital of Thessaloniki, the University General Hospital of Ioannina, the General University Hospital of Larissa and the 401 General Military Hospital of Athens. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody, in people with multiple sclerosis (MS). It is open only to people who complete earlier frexalimab studies on the study drug, such as the Phase 3 studies FREXALT and FREVIVA. The estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed in Greece; it does not mean that it has started at any Greek hospital, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension, so it is not a way for other people with MS in Greece to receive frexalimab. Frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in two EU countries; not a result

Phase 3 extension study authorised in two EU countries; recruitment not yet started

Frexalimab: long-term Phase 3 extension study authorised in Belgium and Austria

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Belgium authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 30 October 2026 and Austria on 1 November 2026. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody given into a vein or under the skin, in people with multiple sclerosis (MS). It is open only to people with relapsing MS or non-relapsing secondary progressive MS who complete earlier frexalimab studies on the study drug, including the Phase 3 studies FREXALT and FREVIVA. It plans 1,710 participants in total. Both countries are listed as authorised with recruitment pending; the estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed; it does not mean that it has started, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension. Greece authorised the study later, on 2 November 2026 (see the separate update); frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsResults from peopleSubgroup finding: significant in Hispanic or Latino participants, not significant in Black participants

Post hoc analysis of two completed Phase 3 trials in relapsing MS

OPERA trials: post hoc look at disability worsening in Black and Hispanic or Latino participants

Organisation: Keck School of Medicine, University of Southern California, with Genentech and Roche · United States

Researchers led by the University of Southern California, with authors from Genentech, Roche and other US centres, re-analysed the OPERA I and II trials, which compared ocrelizumab with interferon beta-1a for two years in relapsing multiple sclerosis (MS). In the interferon group, non-Hispanic Black and Hispanic or Latino participants had a higher risk of disability worsening confirmed after 24 weeks, measured with a combined (composite) disability measure, than non-Hispanic White participants (hazard ratio 3.0 and 2.3). Non-Hispanic Black and Hispanic or Latino participants also had more CD19-positive B cells at the start. In 1,138 participants who consented to genetic analysis, higher African or Americas genetic ancestry was also linked to higher risk. Ocrelizumab lowered B cells in all groups. Compared with interferon, it lowered the risk of this composite disability worsening in Hispanic or Latino participants (hazard ratio 0.38; 95% confidence interval 0.20–0.72). In the 65 Black participants the estimate also pointed to lower risk (hazard ratio 0.41), but the 95% confidence interval of 0.13–1.29 includes no difference, so the result is not statistically significant.

Published by MyelinWatch:

What this means for people with MS

This is not a new treatment or a new approval: ocrelizumab is already an approved MS treatment. The analysis was done after the trials ended, in small subgroups (only 65 Black participants), using self-reported race and ethnicity; it cannot show why risk differed and does not change treatment guidance. The authors conclude that ocrelizumab reduced risk regardless of race or ethnicity, but for Black participants the study alone does not establish this. It does not establish availability or reimbursement in Greece or support changing an individual treatment without a neurologist.

Read the update →Source: Multiple Sclerosis Journal (SAGE) — peer-reviewed primary article ↗Source: Multiple Sclerosis Journal — DOI 10.1177/13524585261496124 ↗ Source: ClinicalTrials.gov — OPERA I (NCT01247324), completed with posted results ↗ Source: ClinicalTrials.gov — OPERA II (NCT01412333), completed with posted results ↗
Research event/source date:
Emerging treatmentsResults from peopleMechanism finding in a small group; no clinical result

Small laboratory study of samples from people with MS; preprint not yet peer reviewed

Preprint: a B-cell subset in neck lymph nodes was not depleted during anti-CD20 treatment

Organisation: University of Helsinki and Helsinki University Hospital · Finland

Researchers at the University of Helsinki and Helsinki University Hospital, Finland, took needle samples from deep lymph nodes in the neck, which drain fluid from the brain, and analysed single cells. They compared samples from people with newly diagnosed multiple sclerosis (MS) before treatment with samples taken during treatment: 5 people on anti-CD20 drugs (3 on rituximab, 2 on ofatumumab), 2 on dimethyl fumarate and 1 on natalizumab. In the blood, anti-CD20 treatment removed almost all B cells. In the lymph nodes, most B-cell types were clearly reduced, but one subset, called double-negative B cells, was not. These cells still carried a gene-activity pattern linked to active Epstein-Barr virus (EBV) infection, and T cells that target EBV and show signs of exhaustion also remained.

Published by MyelinWatch:

What this means for people with MS

This is an early laboratory finding in a small number of people. The authors propose that cells surviving in these lymph nodes could help explain why anti-CD20 drugs need to be given repeatedly; this was not tested. The study does not show that these drugs work less well, that the remaining cells cause relapses or disability, or that EBV drives MS during treatment. No clinical outcome was compared. The preprint has not been peer reviewed. It does not support changing an individual treatment, and it does not concern access to any treatment in Greece.

Read the update →Source: medRxiv preprint by University of Helsinki researchers — original non-peer-reviewed medical preprint ↗Source: medRxiv — preprint version 1, posted 28 October 2026 ↗ Source: Europe PMC — preprint record PPR1352381 ↗
Research event/source date:
Myelin repairResults from peopleNo reported conclusion on effect

Published longitudinal imaging cohort study in people

MRI study follows a myelin-sensitive signal in MS lesions over about one year

Organisation: Second Hospital & Clinical Medical School, Lanzhou University · China

Researchers at the Second Hospital of Lanzhou University, China, used an MRI technique called APART-QSM, which separates a myelin-sensitive (diamagnetic) signal from an iron-sensitive one. At the first scan, white matter lesions had a lower myelin-sensitive signal than the corresponding normal-appearing white matter. In the 101 people with multiple sclerosis who had a second scan after a median of about one year, the myelin-sensitive signal in lesions increased. Larger increases were associated with female sex, ofatumumab treatment, relapsing-remitting MS and improvement in EDSS disability scores, and they were smaller with longer disease duration.

Published by MyelinWatch:

What this means for people with MS

The work tests whether this MRI method could track changes linked to remyelination. It does not show that myelin was restored, that ofatumumab repairs myelin, or that the signal explains changes in disability: this was an observational cohort with no randomised comparison of treatments, and about 30% of the people with MS had no follow-up scan. There is still no established approved treatment in clinical practice proven to reliably restore myelin in MS. It does not support a change to an individual treatment.

Read the update →Source: Journal of Magnetic Resonance Imaging (Wiley) — peer-reviewed primary article ↗
Research event/source date:
Myelin repairLaboratory or animal researchLess myelin damage and inflammation in mouse models; not clinical benefit

Mouse experiments; not tested in people

Mouse study links chronic demyelination to a dysfunctional microglial state

Organisation: Technical University of Munich and German Center for Neurodegenerative Diseases (DZNE) · Germany

Researchers at the Technical University of Munich and the German Center for Neurodegenerative Diseases (DZNE) compared mouse models of acute and chronic myelin loss. With chronic demyelination, microglia, the brain's immune cells, entered a distinct state with ongoing inflammation, fats trapped inside their lysosomes and fewer lipid droplets, together with higher cholesterol production and lower cholesterol export. A desmosterol-like compound (DMHCA) reversed this state, reduced inflammatory signalling and myelin damage, and improved movement in a mouse model of the inherited myelin disorder Pelizaeus–Merzbacher disease. In experimental autoimmune encephalomyelitis (EAE), a mouse model used to study MS, DMHCA lessened disease severity and reduced lesions. In post-mortem tissue from chronic active MS lesions of 3 people, about 75% of phagocytic immune cells (CD68+) carried a marker of this inflammatory state (CCL4), compared with about 13% in white matter from people without MS.

Published by MyelinWatch:

What this means for people with MS

The study points to a possible research target for chronic myelin damage, including in MS. The compound was given only to mice, EAE mice do not reproduce all features of MS, and the human finding is a small descriptive tissue observation, so the work cannot show that the compound would be safe or useful for people with multiple sclerosis. There is no established approved treatment in clinical practice proven to reliably restore myelin in MS. It does not support a change to an individual treatment.

Read the update →Source: Nature Neuroscience — peer-reviewed primary article ↗
Research event/source date:
Myelin repairLaboratory or animal researchMore maturing myelin-forming cells in aged rodents; not clinical benefit

Rat cell and mouse experiments; not tested in people

Rodent study: restoring BCL11A helped aged myelin precursor cells mature

Organisation: Altos Labs-Cambridge Institute of Science and University of Cambridge · United Kingdom

Researchers at Altos Labs-Cambridge Institute of Science and the University of Cambridge, UK, studied why oligodendrocyte progenitor cells, the precursor cells that can form new myelin, mature less well with age. Using a new computational method (gSWITCH) on gene-activity data from young and aged rats, they found several regulatory genes with lower activity in aged precursor cells and highlighted one, BCL11A. Blocking BCL11A reduced the maturation of these precursor cells into myelin-forming cells (oligodendrocytes). Adding BCL11A to precursor cells from aged rats in the lab increased the number of oligodendrocytes by about 54% without changing cell division. In 18-month-old mice, raising BCL11A in these cells with a viral gene vector before a chemically induced spinal cord lesion led to more maturing oligodendrocytes in the lesion 14 days later; the authors report no difference in lesion size.

Published by MyelinWatch:

What this means for people with MS

The study points to a gene that may help explain why myelin repair slows with age, a question relevant to MS. It did not test a treatment: BCL11A was raised by gene delivery in rodents, the lesion was chemically induced rather than an MS model, and the study counted maturing cells rather than measuring restored myelin or recovery of function. It cannot show that this approach would be safe or useful for people with multiple sclerosis. There is no established approved treatment in clinical practice proven to reliably restore myelin in MS. It does not support a change to an individual treatment.

Read the update →Source: eLife — peer-reviewed primary article ↗
Research event/source date:
Emerging treatmentsResults from peoplePhase 3: fewer relapses than with teriflunomide

Published results from two randomised Phase 3 trials in relapsing MS

REMODEL-1 and REMODEL-2: remibrutinib lowered relapse rates versus teriflunomide

Organisation: The Lancet

The Lancet published REMODEL-1 and REMODEL-2 results on 23 October 2026. Adults with relapsing multiple sclerosis received remibrutinib 100 mg twice daily or teriflunomide 14 mg daily. The PubMed article abstract reports annualised relapse rates of 0.073 versus 0.112 in REMODEL-1 (rate ratio 0.648, 95% CI 0.453–0.927) and 0.080 versus 0.116 in REMODEL-2 (0.688, 0.487–0.972). The abstract reports common adverse events and fewer adverse-event-related treatment discontinuations with remibrutinib (3.1% versus 5.8%), but full safety tables were not available in this review. These RMS trials are distinct from the separate REMASTER trial in secondary progressive MS.

Published by MyelinWatch:

What this means for people with MS

The two trials support a relapse-rate benefit relative to teriflunomide in the studied RMS population. They do not by themselves establish individual benefit, superiority to every available therapy, prevention of disability progression, or Greek medicine availability. ClinicalTrials.gov currently lists both REMODEL studies as active without taking new participants; seven Greek location rows in REMODEL-2 have generic site labels, not verified named centres or open places.

Read the update →Source: The Lancet — PubMed indexed primary-article abstract ↗Source: REMODEL-1 official trial record ↗ Source: REMODEL-2 official trial record and generic Greek location rows ↗
Research event/source date:
Emerging treatmentsResults from peopleEarly safety and disability observations; benefit unproven

Early human Phase 1 results

Azer-cel: first Phase 1 results in 26 people with progressive MS

Organisation: TG Therapeutics · United States

At the 3 September 2026 data cutoff, 26 people had received azer-cel and median follow-up was 4.9 months. EDSS disability scores were stable or improved in 16/18 evaluable people at Day 90 and 7/8 at Day 180. Grade 3 or higher treatment-emergent adverse events occurred in 11/26, and serious adverse events in 4/26. No dose-limiting toxicity, Grade 3 or higher cytokine-release syndrome, Grade 2 or higher neurotoxicity, graft-versus-host disease or IEC-HS was reported.

Published by MyelinWatch:

What this means for people with MS

The small, uncontrolled study and short follow-up cannot show that azer-cel slows disability or is broadly safe. MRI at Day 60 found no new or enhancing lesions in 22 evaluable people, but this does not establish benefit. The sponsor reports ongoing dose escalation and longer follow-up; official registry recruitment and Greek access are unverified.

Read the update →Source: TG Therapeutics — sponsor conference presentation ↗Source: TG Therapeutics — 23 October 2026 announcement ↗
Research event/source date:
Emerging treatmentsResults from peopleDescriptive observations; causality unproven

Peer-reviewed Phase 4 single-arm observational study in 115 US patients with relapsing MS

Cladribine tablets after age 50: 24-month Aging study published

Organisation: Neurology and Therapy

The Aging study followed 115 US patients aged 50 or older with relapsing multiple sclerosis (MS) who received cladribine tablets. Over 24 months the observed annualised relapse rate was 0.07. At least one adverse event occurred in 80/115 (69.6%), a serious adverse event in 8/115 (7.0%), and lymphopenia in 51/115 (44.3%). Only 31 participants were aged 65 or older.

Published by MyelinWatch:

What this means for people with MS

These observations add information for older patients but the single-arm design cannot show that cladribine caused the low relapse rate or is safer or more effective than alternatives. Selection and retention of patients and incomplete imaging can bias results; the age-65 subgroup is small. EMD Serono/Merck funded and participated in design, analysis and manuscript preparation. This US study does not establish Greek availability or reimbursement or justify a treatment change without clinical review.

Read the update →Source: Neurology and Therapy — peer-reviewed research article ↗Source: PubMed — Aging original article, PMID 42905248 ↗
Research event/source date:
Emerging treatmentsResults from peopleMixed findings

Published observational study in 41 people with paediatric-onset MS

Swiss paediatric MS cohort describes changes in first treatment choices

Organisation: Multiple Sclerosis and Related Disorders

Researchers described 41 people with paediatric-onset multiple sclerosis in a Swiss registry. Of 39 treated after diagnosis, 15 began a mild-efficacy, 13 an intermediate-efficacy and 11 a high-efficacy therapy. Mean annualised relapse rates fell after treatment in each group (1.07 to 0.43; 1.17 to 0.33; and 1.73 to 0.09 respectively). Discontinuation was reported in 67%, 54% and 18% of the respective groups. The authors report that after 2019 the cohort no longer used mild-efficacy drugs as first treatment.

Published by MyelinWatch:

What this means for people with MS

This small, descriptive cohort shows how a multicentre Swiss registry recorded care of people with paediatric-onset MS; the groups differed before treatment and were not randomised. It cannot show that one treatment category is better for an individual with paediatric-onset MS, establish long-term safety, or determine access in Greece. Treatment choices require a specialist experienced in paediatric-onset MS.

Read the update →Source: Multiple Sclerosis and Related Disorders — PubMed indexed primary-article abstract ↗
Research event/source date:
Myelin repairResults from peopleNo reported conclusion on effect

Published matched observational biomarker study in people

Cholesterol and inflammation markers differ with severe progressive MS disability

Organisation: Annals of Clinical and Translational Neurology

Investigators compared blood lipids, apolipoproteins, nutritional and inflammatory markers in 53 people with severe progressive multiple sclerosis requiring skilled nursing and 53 matched community-dwelling people with progressive MS. The severe group had lower HDL cholesterol, ApoA-I, ApoA-II and albumin, and higher ApoB, ApoE and GlycA. Several lipid measurements were associated with disability scores. The analysis also found different networks of correlations among metabolic, inflammatory and neural-injury markers.

Published by MyelinWatch:

What this means for people with MS

The work may guide research into progressive-MS biology, including pathways relevant to repair. It cannot tell whether cholesterol changes cause disability, whether a cholesterol medicine would help, or whether myelin was restored. Disease severity, nutrition and other factors may influence the associations. It does not support a change to an individual treatment.

Read the update →Source: Annals of Clinical and Translational Neurology — peer-reviewed primary article ↗
Research event/source date:
Emerging treatmentsResults from peopleEuropean Commission paediatric indication extension

European Commission indication extension on 15 October 2026; OPERETTA 2 Phase 3 evidence is separate

EU authorises intravenous Ocrevus for active relapsing MS from age 10

Organisation: Roche Registration GmbH · Regulator: European Medicines Agency · European Union

On 15 October 2026 the European Commission extended the EU indication for intravenous ocrelizumab (Ocrevus) to patients aged 10 and older with active relapsing multiple sclerosis (MS), defined by clinical or imaging features. EMA updated its product information on 16 October. The September CHMP opinion was an earlier step. Phase 3 OPERETTA 2 evidence, its registry status and its posted results are separate from this regulatory event.

Published by MyelinWatch:

What this means for people with MS

The decision adds an EU-authorised option for eligible children under specialist care. It does not establish individual eligibility, superiority, myelin repair, Greek availability or reimbursement. A separate EMA safety communication disseminated on 8 October warns of drug-induced liver injury and recommends liver-function monitoring; the communication says its frequency is unknown. That safety event is not the 15 October decision.

Read the update →Source: European Medicines Agency — official EMA medicine record ↗Source: ClinicalTrials.gov — OPERETTA 2 NCT05123703, active without recruitment, posted results ↗ Source: EMA — separate 8 October 2026 drug-induced liver injury safety communication ↗ Source: EMA — earlier CHMP opinion, 17 September 2026 ↗
Research event/source date:
Myelin repairLaboratory cells onlyNo reported conclusion on effect

Human-cell laboratory model, not a clinical study

Human spinal-cord organoids model oligodendrocyte states relevant to MS

Organisation: Stem Cell Reports

Researchers built human spinal-cord organoids and cortico-motor cell assemblies containing oligodendrocyte-lineage cells. Progenitor cells showed migration and neuronal inputs. After inflammatory-cytokine exposure, the cells developed gene-expression changes resembling some signatures found in MS tissue. This supplies a laboratory tool for studying cell states; the study did not administer a myelin-repair treatment to people.

Published by MyelinWatch:

What this means for people with MS

The model may help future mechanism studies, but resemblance to human MS tissue does not prove that myelin can be repaired in patients or that any medicine works. It offers no clinical access or treatment choice today. No approved treatment has been shown to reliably restore myelin in MS clinical practice.

Read the update →Source: Stem Cell Reports — PubMed indexed primary-article abstract ↗
Research event/source date:
Emerging treatmentsResults from peopleSome MRI rims became undetectable; clinical benefit unproven

Retrospective results in people with multiple sclerosis

After AHSCT, some iron rims around MS lesions were no longer visible on MRI

Organisation: University Hospital Careggi, Florence · Italy

Florence researchers examined MRI scans from 30 people after autologous haematopoietic stem cell transplantation (AHSCT). Twelve had scans before and after the procedure: 5 of 26 iron-containing rims around lesions became undetectable in 2 of the 5 people who initially had such lesions, over a median 21 months of MRI follow-up. The other 18 had scans only after AHSCT: 10 of 20 rims became undetectable in 4 of the 7 people with such lesions, over a median 51 months. The groups were analysed separately.

Published by MyelinWatch:

What this means for people with MS

An iron rim is an MRI finding linked to iron-containing cells at the edge of some MS lesions. A rim becoming undetectable does not mean that the underlying lesion disappeared or that myelin was repaired: in the paper's example, the lesion remained visible. This small retrospective study cannot show that AHSCT improved disability or caused the MRI change. This finding alone is insufficient to change treatment and does not establish access in Greece.

Read the update →Source: Multiple Sclerosis Journal / SAGE — peer-reviewed research article ↗
Research event/source date:
Emerging treatmentsLaboratory or animal researchPositive laboratory or animal findings, not clinical benefit

Laboratory and mouse-model research; no human MS study established

Artificial lymph-node scaffold induced immune tolerance in an MS animal model

Organisation: Science Translational Medicine

Researchers built a 3D-printed scaffold intended to keep tolerogenic dendritic cells in a protected immune niche and recruit naïve T cells. In EAE mice, implantation increased antigen-specific regulatory T cells and reduced disease activity even after the model was established. Removing regulatory T cells eliminated the experimental effect. The paper also reports changes in inflammatory B cells and microglial profiles in model systems.

Published by MyelinWatch:

What this means for people with MS

This is an immune-tolerance research platform, not a treatment available to people with multiple sclerosis. EAE is not human MS; the animal findings cannot establish benefit in people, safety, durable remission, or access in Greece. No approved treatment has been shown to reliably restore myelin in MS clinical practice.

Read the update →Source: Science Translational Medicine — PubMed indexed primary-article abstract ↗
Research event/source date:
Emerging treatmentsLaboratory or animal researchLower EAE severity and Kupffer-cell-dependent tolerance in mice

Laboratory or animal research experiments in mice with experimental autoimmune encephalomyelitis (EAE)

Peptide-coupled red blood cells: Kupffer cells mediate tolerance in mice

Organisation: University of Zurich research group

Published online on 7 October 2026 in Science Advances, this study examined peptide-coupled red blood cells (pcRBCs). In mice with experimental autoimmune encephalomyelitis, a model used in multiple sclerosis (MS) research, the approach was associated with less severe disease. Mechanistic experiments showed that liver Kupffer cells were necessary for the observed antigen-specific immune tolerance.

Published by MyelinWatch:

What this means for people with MS

The work helps explain a possible mechanism of the pcRBC approach. EAE is not human MS: reduced disease severity in mice does not establish benefit to patients, safety or myelin repair in people. The separate, earlier RED4MS early human study of CLS12311 is not a result of this 7 October paper. This study does not establish an available treatment or access and reimbursement in Greece.

Read the update →Source: Science Advances (AAAS) — peer-reviewed research article ↗Source: Science Advances — original article DOI ↗ Source: PubMed — PMID 42842659 ↗
Research event/source date:
Emerging treatments + myelin repairPlanned study in peopleStudy start-up agreement signed

Planned Phase 2 trial

Lucid-MS: study start-up agreement for a planned Phase 2 trial

Organisation: Quantum BioPharma / Lucid Psycheceuticals

Quantum BioPharma says it signed a Study Start-Up Agreement with Thermo Fisher Scientific's PPD clinical research business to prepare a planned Phase 2 trial of Lucid-21-302 (Lucid-MS) in people with progressive forms of multiple sclerosis (MS). The planned trial would compare Lucid-MS with placebo and assess efficacy, safety and tolerability.

Published by MyelinWatch:

What this means for people with MS

The agreement is an operational step toward a study. It does not establish that recruitment or dosing has begun, that Lucid-MS benefits people with MS, or that it repairs myelin. No approved treatment in clinical practice has been proven to reliably restore myelin in MS. No trial participation option in Greece was announced.

Read the update →Source: Quantum BioPharma — company announcement filed with the US Securities and Exchange Commission ↗
Research event/source date:
Emerging treatmentsResults from peopleOverall 10-year disability finding; extension-only and PIRA comparisons not significant

Post hoc 10-year follow-up analysis of two Phase 3 trials in relapsing MS

Ocrelizumab: full 10-year OPERA I and II analysis published

Study sponsor: F. Hoffmann-La Roche Ltd

Published online on 5 October 2026, the full OPERA I and II follow-up analysis covers 1,656 people randomized with relapsing multiple sclerosis (MS). Ocrelizumab was compared with interferon beta-1a for two blinded years; participants entering the open-label extension then received ocrelizumab for up to eight more years. Across the full period, earlier ocrelizumab was associated with a lower hazard of disability progression confirmed for 48 weeks (hazard ratio 0.76; 95% confidence interval 0.61–0.95). The difference was largely established during the randomized period. After the switch, the extension-only comparison did not show a new difference (hazard ratio 1.02; 95% confidence interval 0.81–1.28).

Published by MyelinWatch:

What this means for people with MS

This adds full peer-reviewed long-term evidence for earlier treatment in relapsing MS, but the 10-year comparison was not randomized throughout: 853 of 1,656 originally randomized participants completed follow-up. Attrition and post hoc analysis limit causal interpretation. The 10-year comparison for progression independent of relapse activity (PIRA) was not statistically significant; this paper does not prove remyelination or effects in primary progressive MS. Serious infections and declining IgG occurred, so stable observed adverse-event rates do not mean no risk. This paper does not establish Greek availability or reimbursement.

Read the update →Source: JAMA Neurology — peer-reviewed paper ↗Source: ClinicalTrials.gov — OPERA I (NCT01247324), completed with posted results ↗ Source: ClinicalTrials.gov — OPERA II (NCT01412333), completed with posted results ↗
Research event/source date:
Myelin repairLaboratory cells onlyLaboratory model of myelin repair; no clinical outcome

Peer-reviewed laboratory model using human stem-cell-derived tissue; no patients treated

Human cell spheroids model myelin injury and repair in the laboratory

Organisation: Ramesan et al. research team

A Nature Neuroscience paper published on 1 October 2026 describes three-dimensional spheroids made from human induced pluripotent stem cells. They contain myelinating oligodendrocytes and responsive microglia. After experimentally induced myelin injury, researchers observed debris clearance, generation of new oligodendrocytes and new, thinner myelin sheaths around axons. Remyelination was observed in only about half of differentiations. Developmental maturity is another limitation: stem-cell-derived models may not fully reflect adult tissue. The model can help study repair mechanisms and screen candidate compounds, but a spheroid cannot reproduce all features of adult multiple sclerosis (MS).

Published by MyelinWatch:

What this means for people with MS

This is laboratory research, not a clinical trial or a treatment. No person with MS received an intervention in this study, and the paper does not demonstrate restored myelin or improved disability in patients. Any drug lead from this model would need separate testing. It establishes no treatment access in Greece.

Read the update →Source: Nature Neuroscience — Ramesan et al. — original peer-reviewed research article ↗Source: PubMed — Nature Neuroscience original article PMID 42823475 ↗
Research event/source date:
Emerging treatmentsResults from peopleFDA application accepted for Priority Review, according to Roche

US new drug application accepted for FDA Priority Review, according to Roche

Fenebrutinib: Roche says FDA accepted MS application for priority review

Organisation: Roche

On 30 September 2026, Roche announced that the US FDA had accepted its new drug application for investigational fenebrutinib, an oral BTK inhibitor, for relapsing and primary progressive multiple sclerosis under Priority Review. The application draws on three Phase 3 studies. Roche reported annualised relapse rates 51.1% and 58.5% lower than with teriflunomide in FENhance 1 and 2 over 96 weeks. In FENtrepid, fenebrutinib met the prespecified noninferiority comparison with ocrelizumab for disability progression: it was not worse by more than the study's pre-set margin. The reported hazard ratio was 0.88 (95% confidence interval 0.75–1.03).

Published by MyelinWatch:

What this means for people with MS

Acceptance for Priority Review starts an FDA assessment; it is not approval or evidence that fenebrutinib is available to patients. The FENtrepid result establishes noninferiority in that comparison, not superiority. Roche reported more liver-enzyme elevations with fenebrutinib in FENtrepid and an imbalance in the number of deaths between treatment arms across the three trials; causes varied and these safety findings need careful assessment. The cited sources do not establish access in Greece.

Read the update →Source: Roche — official company announcement ↗Source: Roche — FENhance 1 and 2 relapsing MS results and safety ↗ Source: Roche — FENtrepid primary progressive MS noninferiority results and safety ↗ Source: ClinicalTrials.gov — FENhance 1 (NCT04586010) ↗ Source: ClinicalTrials.gov — FENhance 2 (NCT04586023) ↗ Source: ClinicalTrials.gov — FENtrepid (NCT04544449) ↗
Research event/source date:
Emerging treatmentsResults from peopleTwo case observations; no proven benefit

Peer-reviewed case report in two treated people; limited follow-up

C-CAR168: two uncontrolled CAR-AID cases in secondary progressive MS

Study sponsor: RenJi Hospital / CAR-AID

A case report published on 29 September 2026 describes two people with treatment-refractory secondary progressive multiple sclerosis (MS) who received C-CAR168 in CAR-AID. Disability scores changed from 4.0 to 3.0 at 12 months and from 6.5 to 6.0 at 6 months. The authors also report MRI and immune-marker changes and mild adverse events, including grade 1 cytokine-release syndrome. These are observations in two people without a comparison group.

Published by MyelinWatch:

What this means for people with MS

The changes cannot establish that C-CAR168 caused benefit to patients or repaired myelin. Two cases and 6–12 months of follow-up cannot define long-term safety. This remains an experimental intervention, with no established availability or reimbursement in Greece. The separate US NCT07825389 has no posted results.

Read the update →Source: Frontiers in Immunology — peer-reviewed original case report ↗Source: ClinicalTrials.gov — CAR-AID NCT06249438 ↗
Research event/source date:
Emerging treatments + myelin repairRegistered study in peopleRecruitment update; no efficacy results posted

Registered early Phase 1/2a human study; estimated start remains October 2026

PRO-1562 study record now lists recruitment in Australia

ClinicalTrials.gov changed the overall status of NCT07826689 to Accepting participants and lists one site accepting participants in Adelaide, Australia. PRO-1562 is an experimental oral small molecule. The combined early study plans a Phase 1 safety part in healthy adults and a later Phase 2a part in people with relapsing MS and chronic optic neuropathy to test whether the drug may support myelin repair. Repair is a study objective, not a demonstrated effect. Its recorded start is still estimated for October 2026. The status change does not establish that anyone has enrolled or received PRO-1562, or that the MS part is open. No study results are posted.

Published by MyelinWatch:

What this means for people with MS

The registry now provides a recruitment lead in Australia, but it does not show a treatment benefit or availability in Greece. People interested in eligibility should use the current registry contacts; the planned MS cohort should not be assumed open from the overall status alone. There is no established approved treatment in clinical practice proven to reliably restore myelin in MS.

Read the update →Source: ClinicalTrials.gov — official clinical-trial registry ↗Source: Current NCT07826689 study record ↗
Research event/source date:
Emerging treatmentsResults from peopleMixed biomarker changes; clinical benefit was not tested anew

Results from people: biomarker analysis of a completed MS transplant study

AHSCT study reports lasting changes in inflammation and nerve-injury biomarkers

Researchers measured about 50 blood and spinal-fluid markers before and for years after autologous hematopoietic stem-cell transplantation in 24 people with severe multiple sclerosis. Many inflammation-related markers and neurofilament light chain decreased over time. In spinal fluid, GFAP and IL-7 instead increased. Blood and spinal-fluid changes often differed. This is a new analysis of samples from the earlier HALT-MS study, not a new trial of treatment effectiveness.

Published by MyelinWatch:

What this means for people with MS

The findings help researchers understand biological changes after AHSCT. Biomarker changes alone do not show that an individual patient will improve, establish myelin repair, or change who should receive this intensive procedure. The paper does not establish access in Greece.

Read the update →Source: Neurology: Neuroimmunology & Neuroinflammation — peer-reviewed research article ↗Source: PubMed entry for the original biomarker analysis ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudy registration and recruitment status; no results posted

Registered Phase 2a study; start estimated for October 2026

SUN-627: Phase 2a study registered for progressive MS

Organisation: Sundance Biosciences Inc.

ClinicalTrials.gov first posted NCT07840326 on 25 September 2026. This Phase 2a study of SUN-627 plans to enrol 20 adults aged 18–70 with primary progressive MS or non-active secondary progressive MS. It compares two once-daily oral dose levels with placebo. Its primary outcome is safety, measured by adverse events over 16 weeks; secondary outcomes include plasma peak concentration and neuroinflammation biomarkers at 12 weeks. The registry lists the overall study and three US sites in Atlanta, Raleigh and Columbus as open to participants. The October 2026 start is estimated.

Published by MyelinWatch:

What this means for people with MS

Registration is a study plan, not evidence that SUN-627 works or is an available treatment. The open-to-participants listing does not establish that this study has actually started or that anyone has received SUN-627. No NCT07840326 results are posted; this record does not establish benefit for symptoms or disability or myelin repair. It lists three US sites and no Greek site; current registry contacts give the study's eligibility details.

Read the update →Source: ClinicalTrials.gov — official clinical-trial registry ↗Source: Sundance Biosciences — SUN-627 programme and sponsor-described TYK2 mechanism ↗ Source: ClinicalTrials.gov — dated NCT07840326 record history ↗
Research event/source date:
Emerging treatmentsPeer-reviewed reviewResearch synthesis; no new clinical result

Review of existing research; no new clinical results

The alpha7 receptor in MS: a review of immune-signalling research

The alpha7 nicotinic acetylcholine receptor receives chemical signals that can influence immune activity. The review discusses MS-related animal disease models and toxin-induced myelin damage, with possible immune and nerve-protection mechanisms.

Published by MyelinWatch:

What this means for people with MS

Important limits include the receptor becoming less responsive, limited entry of candidate substances into the brain and unvalidated biological markers. The review establishes no benefit to patients for MS and does not support nicotine use or treatment advice.

Read the update →Source: Life Sciences — peer-reviewed paper ↗
Research event/source date:
Emerging treatmentsResults from peopleInfection safety signal in adults aged 55 and older; observational association

Published retrospective cohort study in adults aged 55 years and older with multiple sclerosis

Ocrelizumab and infection risk from age 55: a cohort study

Organisation: Massachusetts General Hospital

Published on 24 September 2026, this Massachusetts General Hospital study examined 1,600 adults aged 55 years or older with multiple sclerosis (MS): 800 who received at least 600 mg of intravenous ocrelizumab and 800 who had never received a B-cell-depleting treatment. Using person-time and adjustment for measured group differences, the researchers found higher rates in the ocrelizumab group for infection-related hospitalization (incidence rate ratio 1.67; 95% confidence interval 1.15–2.43) and infections overall (1.42; 95% confidence interval 1.20–1.68).

Published by MyelinWatch:

What this means for people with MS

This safety signal can inform a discussion with a treating neurologist about individual infection risk and monitoring. It does not prove that ocrelizumab caused the difference or predict an individual's risk. The groups differed in age and follow-up (median 3.5 versus 8.2 years), and the retrospective records may capture infections differently because treatment recipients had more structured clinical contact. Treatment selection, missing disability data, and possible immortal-time bias also limit causal interpretation. This study does not test MS efficacy, support changing treatment without clinical review, or establish Greek availability or reimbursement.

Read the update →Source: The Lancet Regional Health – Americas — peer-reviewed research article ↗Source: PubMed — PMID 42834886 ↗ Source: The Lancet Regional Health – Americas — DOI 10.1016/j.lana.2026.101640 ↗
Research event/source date:
Emerging treatmentsResults from peopleMixed observational findings; cause and effect not established

Observational results in people with MS; 24-month follow-up

LIMS follow-up finds modest, mainly short-term changes after a lifestyle programme

In the LIMS observational study, 659 people with multiple sclerosis joined a three-month programme covering Mediterranean-style diet, physical activity, sleep and stress, followed by 21 months of maintenance. Average patient-reported MS impact improved modestly during the programme, then the improvement generally weakened or stabilised. Across follow-up assessments, approximately 4–7% exceeded the threshold for a detectable individual change on the MS Impact Scale. Dietary adherence and body mass index improved; physical-activity adherence did not change significantly. There was no concurrent control group, so the study cannot establish that the programme caused the changes or altered the disease course.

Published by MyelinWatch:

What this means for people with MS

This suggests a possible complementary way to support daily wellbeing, not a replacement for disease-modifying treatment. The small average changes and observational design do not establish a clinical treatment effect or MS disease modification. The article does not establish access to this specific programme in Greece.

Read the update →Source: Neurology — peer-reviewed research article ↗Source: PubMed entry for the original LIMS follow-up ↗
Research event/source date:
Myelin repairLaboratory or animal researchMouse/cell mechanism; no clinical result

Mouse and primary-cell research; unreviewed preprint

Virus-infected mice and myelin-making cells: an unreviewed Cx47 mechanism study

In a mouse coronavirus model and primary cell cultures, infection injured oligodendrocytes, the cells that make myelin, and reduced markers of mature, myelinating cells. This raises the possibility of impaired maturation or myelination. The preprint reports ERK2-driven phosphorylation, a chemical modification, at Ser372 on the Cx47 communication protein.

Published by MyelinWatch:

What this means for people with MS

This is a mechanistic finding, not a human MS study. It does not show that a virus causes MS, that myelin was repaired or that patients benefit. The preprint has not undergone peer review; this summary is based on its abstract. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: bioRxiv — original preprint, not peer reviewed ↗
Research event/source date:
Emerging treatmentsPeer-reviewed reviewResearch synthesis; no new clinical result

Review of existing research; no new clinical results

Targeting B cells in MS: established treatments and experimental approaches

B cells are immune cells involved in MS. This review compares evidence for established anti-CD20 treatments, which target a B-cell protein, with investigational approaches affecting BTK signalling, BAFF survival signals or engineered CAR immune cells.

Published by MyelinWatch:

What this means for people with MS

The approaches are not all approved, equivalent or tested in combination. Possible effects of CAR approaches inside the brain remain investigational. This synthesis reports no new clinical cohort or proof of myelin repair and is not a treatment recommendation.

Read the update →Source: Neurological Sciences — peer-reviewed paper ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudies accepting participants; no results posted

Registered Phase 3 studies in people; no results posted

Two Phase 3 orelabrutinib studies for progressive MS are listed as accepting participants

Study sponsor: Zenas BioPharma (USA), LLC

NCT07067463, for primary progressive MS, was updated on 22 September 2026 and plans about 705 participants. NCT07299019, for non-active secondary progressive MS, was updated on 23 September 2026 and plans about 990 participants. Both Phase 3 studies, sponsored by Zenas BioPharma (USA), LLC, are listed as accepting participants. Neither registry record has posted results. These dates mark registry updates, not the start of the studies or recruitment.

Published by MyelinWatch:

What this means for people with MS

The records describe plans to test orelabrutinib in progressive MS, not established benefit. The primary progressive MS study examines disability worsening confirmed for at least 12 weeks using a composite measure. The non-active secondary progressive MS study examines worsening on the EDSS disability scale confirmed for at least 24 weeks. This is an experimental treatment; these records do not establish myelin repair or an available treatment. Participation depends on each study’s criteria and locations.

Read the update →Source: ClinicalTrials.gov — official clinical-trial registry ↗Source: ClinicalTrials.gov — NCT07067463, primary progressive MS; update posted 22 September 2026 ↗
Research event/source date:
Myelin repairResults from peopleRegistry results; comparative effect not established

Small randomized feasibility study in people

Small exercise study posts results without establishing a comparative effect

Baseline median SSEP Z-scores were 3.83 for exercise and 2.87 for education, with 16 participants per group. Week-24 medians were 3.22 and 1.92, with 14 exercise and 15 education participants. No statistical comparison between the groups is posted.

Published by MyelinWatch:

What this means for people with MS

Somatosensory evoked potentials (SSEP) record the nervous system’s electrical response to sensory stimulation. These are separate medians, not individual changes or estimates of an exercise effect. They do not establish benefit to patients or remyelination. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: ClinicalTrials.gov — Oregon Health and Science University — official ClinicalTrials.gov record ↗
Research event/source date:
Emerging treatmentsLaboratory or animal researchPositive animal-model findings, not clinical benefit

Peer-reviewed animal-model study

Kamuvudine-9 study reports findings in a mouse model of MS

The paper reports that K-9 limited and reversed some vision and movement problems in mice with experimental autoimmune encephalomyelitis, an MS model, and preserved nerve cells and myelin. A separate insurance-data analysis in the paper concerns other NRTI medicines, not K-9.

Published by MyelinWatch:

What this means for people with MS

The findings are from animals and do not show that K-9 benefits people with MS. Associations involving other NRTIs are not clinical evidence for K-9.

Read the update →Source: Science Translational Medicine — peer-reviewed primary article ↗Source: NIH summary (animal findings and separate NRTI analysis) ↗
Research event/source date:
Emerging treatments + myelin repairPeer-reviewed reviewReview of existing evidence

Peer-reviewed review

Stem-cell review separates immune treatment from experimental myelin repair

Autologous hematopoietic stem-cell transplantation (AHSCT) has the most mature clinical evidence for carefully selected highly active relapsing MS despite high-efficacy therapy, through immune reconstitution. Approaches using mesenchymal stromal cells (MSC) remain investigational, with inconsistent controlled-trial efficacy and safety concerns for intrathecal administration.

Published by MyelinWatch:

What this means for people with MS

These approaches are not interchangeable. Immune-treatment evidence does not establish direct myelin repair or a universal cure. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: Medical Science Monitor — official research source ↗
Research event/source date:
Emerging treatmentsPeer-reviewed reviewResearch synthesis; no new clinical result

Review of existing research; no new clinical results

CAR-T cells and gut microbiota: a review of separate MS research approaches

The review discusses engineered T immune cells (CAR-T) targeting B immune cells and research on gut microbes and their metabolites. It draws on previous pilot patient studies and animal models, rather than reporting a new patient cohort.

Published by MyelinWatch:

What this means for people with MS

The approaches are separate. This review does not establish a combined therapy, proven clearance of disease-causing cells from the brain, or patient benefit from changing gut microbes. It does not support treatment, diet or probiotic recommendations.

Read the update →Source: Current Issues in Molecular Biology — peer-reviewed paper ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleParticipation in Greece reported; no results

Phase 3 study in secondary progressive MS

REMASTER: the EU register reports recruitment starting in Greece

Study sponsor: Novartis

The EU REMASTER record lists Greece as a country accepting participants, with a reported start on 18 September 2026. It names seven Greek centres. REMASTER compares remibrutinib with placebo in secondary progressive multiple sclerosis (MS). The date is a country-level registry report, not proof that every centre began accepting people on that day.

Published by MyelinWatch:

What this means for people with MS

The listing offers a way to explore study participation, not evidence that the drug works or approved treatment access. The relevant centre must confirm current recruitment and eligibility. REMASTER has no posted results, and Greek commercial availability or reimbursement for this use is not established.

Read the update →Source: EU Clinical Trials Information System — official EU clinical-trial registry ↗
Research event/source date:
Myelin repairLaboratory cells onlyLaboratory platform; no clinical efficacy evidence

Laboratory model with human-derived cells

A human-cell myelin model for studying treatment responses in the laboratory

Organisation: bioRxiv / Chunhui Tian and colleagues

Chunhui Tian and colleagues describe neural organoids on 3D-printed devices containing directional microfibres with oligodendrocyte progenitor cells, then add T cells and monocytes from people with MS. Laboratory responses distinguished responder and nonresponder profiles after exposure to prednisone, glatiramer acetate, interferon beta-1a or dimethyl fumarate.

Published by MyelinWatch:

What this means for people with MS

Human-derived cells are not a trial in patients. This model does not establish treatment efficacy, benefit to patients or remyelination in people. No approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: bioRxiv — original preprint, not peer reviewed ↗
Research event/source date:
Emerging treatments + myelin repairResults from peopleBiological signal in biomarkers, not proof of clinical benefit

Results from people

MSC-NP study finds CSF biomarker changes in two progressive MS cohorts

Organisation: Tisch Multiple Sclerosis Research Center of New York · United States

A published analysis examined cerebrospinal-fluid samples from two groups of people with secondary or primary progressive MS: 50 participants in a Phase 2 study and 43 in an expanded-access programme. After repeated intrathecal autologous MSC-NP treatment, CCL2, MMP9, SCF and CHIT1 changed in cerebrospinal fluid. NfL and GFAP did not show the same pattern of change.

Published by MyelinWatch:

What this means for people with MS

These findings may help measure biological response and guide future study design. They do not show remyelination, improvement in symptoms or disability, or an established benefit to patients.

Read the update →Source: Stem Cells Translational Medicine / Tisch Multiple Sclerosis Research Center of New York — peer-reviewed primary article ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleRegistered study plan; no results

Registered early human study; not yet accepting participants in the 13 October 2026 registry update

C-CAR168: a US Phase 1b/2 study in progressive MS was registered

Study sponsor: AbelZeta

ClinicalTrials.gov first posted NCT07825389 on 17 September 2026. The Phase 1b/2 study plans to assess C-CAR168 safety and whether it helps people with treatment-refractory progressive multiple sclerosis (MS), including secondary and primary progressive MS, not relapsing-remitting MS. Its registry lists an estimated 119 participants, two US sites and an estimated start in February 2027. The 13 October 2026 update lists it as not yet accepting participants, with no results posted. This is separate from the Chinese CAR-AID study that supplied the published two-person case report.

Published by MyelinWatch:

What this means for people with MS

Registration describes a study plan, not proof that anyone in this US study has been enrolled or treated, or that C-CAR168 works. The estimated start can change. The registry shows no Greek site or access; treatment availability and reimbursement in Greece are not established.

Read the update →Source: ClinicalTrials.gov / US National Library of Medicine — official clinical-trial registry ↗
Research event/source date:
Emerging treatments + myelin repairPlanned study in peopleA registry plan is not a study result

Planned Phase 1/2a study

PRO-1562 registry entry outlines a planned early study

The ClinicalTrials.gov record NCT07826689 describes a planned two-part study: single doses in healthy adults, followed by monthly doses in adults with relapsing MS and chronic optic neuropathy. The 17 September 2026 posting date and study details were available through a secondary mirror attributing them to ClinicalTrials.gov; they could not be independently checked against the primary record.

Published by MyelinWatch:

What this means for people with MS

This is a research plan, not a result. Current recruitment and whether the study has started remain unconfirmed.

Read the update →Source: ClinicalTrials.gov — official clinical-trial registry ↗Source: Veeva mirror reporting ClinicalTrials.gov data (secondary source) ↗
Research event/source date:
Myelin repairLaboratory or animal researchPositive laboratory or animal findings, not clinical benefit

Laboratory and animal research

Blocking fibronectin restored remyelination in experimental models

A PNAS study found that a protein called fibronectin can build up in areas where myelin has been lost. This may trap immature cells that could otherwise become myelin-making cells. Blocking fibronectin improved myelin repair and symptoms in two animal models.

Published by MyelinWatch:

What this means for people with MS

This points to an interesting new biological target, but the approach has not been tested in people and there is no approved medicine based on it.

Read the update →Source: PubMed / PNAS — peer-reviewed paper ↗
Research event/source date:
Emerging treatmentsResults from peopleExploratory findings in two people; no proven benefit

Phase 1, uncontrolled report of two treated participants; preprint

miv-cel CAR-T: immune findings in two people with progressive MS

Organisation: University of California, San Francisco research team

A preprint posted on 11 September 2026 reports two women with treatment-refractory secondary progressive multiple sclerosis (MS) who received low-dose autologous anti-CD19 CAR-T cells, mivocabtagene autoleucel (miv-cel, also called KYV-101), after fludarabine and cyclophosphamide conditioning. CAR-T cells appeared in cerebrospinal fluid and exploratory immune measures changed. MRI findings were stable; observed disability scores changed, but with only two participants, no comparison group and conditioning treatment, these observations cannot establish that miv-cel caused benefit to patients. Reported adverse effects and laboratory abnormalities included grade 3 liver-enzyme elevation, neutropenia and lymphopenia in participant 1, with hypogammaglobulinaemia requiring immunoglobulin and a delayed rash; participant 2 had grade 4 lymphopenia and grade 1 cytokine-release syndrome treated with tocilizumab and dexamethasone. Conditioning chemotherapy may have contributed to blood-count changes.

Published by MyelinWatch:

What this means for people with MS

This is an experimental early human study, not evidence of an effective or available MS treatment or myelin repair. The preprint has not undergone journal peer review. The registry lists the Phase 1 study as active but not accepting new participants; the paper says further recruitment stopped after Kyverna, a study collaborator, shifted its development focus. The cited sources do not establish access in Greece.

Read the update →Source: Gupta et al. — medRxiv — original non-peer-reviewed medical preprint ↗Source: ClinicalTrials.gov — NCT06451159, Phase 1 study status and design ↗ Source: PubMed — preprint record PMID 42818477 ↗
Research event/source date:
Myelin repairPeer-reviewed reviewReview of existing evidence

Peer-reviewed review

Review examines S1P modulators and myelin repair

Reviews cell, animal and human-marker studies of fingolimod, siponimod, ponesimod and ozanimod. Most repair evidence is laboratory-based; human imaging findings are indirect.

Published by MyelinWatch:

What this means for people with MS

Existing MS use of these medicines does not establish a remyelination indication. This is a review, not a new clinical trial. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: Frontiers in Immunology — official research source ↗
Research event/source date:
Emerging treatments + myelin repairPreparing for a first study in peopleNo evidence of benefit in people yet

Preparing for human testing

Low-dose theophylline patch receives funding to prepare for its first study in people

Organisation: Johannes Gutenberg University Mainz · Germany

Claire Jacob's team at Johannes Gutenberg University Mainz announced €1.1 million to improve the skin patch, manufacture it to pharmaceutical standards and prepare a first safety study in healthy volunteers.

Published by MyelinWatch:

What this means for people with MS

The funding brings the patch closer to human testing, but the first study is not yet publicly registered and there is no evidence of benefit in people with MS.

Read the update →Source: Johannes Gutenberg University Mainz — official university research update ↗
Research event/source date:
Emerging treatmentsResults from peopleNo reported conclusion on effect

Published pharmacokinetic model using samples from 11 people with relapsing MS

Small ocrelizumab model explores B-cell timing, without testing a new dosing schedule

Organisation: Clinical Pharmacokinetics

Researchers combined serum ocrelizumab measurements and CD19-positive B-cell counts from 11 people newly diagnosed with relapsing-remitting multiple sclerosis. A two-compartment model described drug exposure and B-cell depletion/repopulation, and simulations explored timing of follow-up measurements. The study did not randomise people to different infusion intervals or measure whether model-guided dosing changed relapses, disability or safety.

Published by MyelinWatch:

What this means for people with MS

The model is an early research tool, not a validated instruction to delay, advance or skip an infusion. An individual dosing change requires clinical judgment and evidence beyond this small dataset. The article does not establish a new treatment or an access change in Greece.

Read the update →Source: Clinical Pharmacokinetics — peer-reviewed primary article ↗
Research event/source date:
Emerging treatments + myelin repairRegistered study in peopleNo reported conclusion on effect

Phase 3 study that can add or remove treatments

OCTOPUS: the first review of metformin and alpha-lipoic acid is planned for September 2026

Organisation: MRC Clinical Trials Unit at UCL · United Kingdom

The first OCTOPUS review in progressive MS will assess metformin and alpha-lipoic acid. It will look at brain shrinkage on MRI, disability, walking speed and hand function.

Published by MyelinWatch:

What this means for people with MS

This is one of the nearest important milestones in progressive MS. The review may decide which treatment groups continue, but it is not the final Phase 3 result.

Read the update →Source: OCTOPUS / MRC Clinical Trials Unit at UCL — official trial update ↗
Research event/source date:
Emerging treatments + myelin repairPlanned study in peopleFDA: hold lifted for planned Phase 2

Planned Phase 2 study

Lucid-MS: the FDA removed its temporary pause, allowing a planned Phase 2 study to move forward

Organisation: Quantum BioPharma / Lucid Psycheceuticals · Regulator: US Food and Drug Administration · United States

After an earlier temporary pause, the FDA allowed Lucid-MS to move forward. The company plans a Phase 2 study in progressive MS in which participants will be randomly assigned Lucid-21-302 or an inactive placebo, without knowing which one they receive.

Published by MyelinWatch:

What this means for people with MS

This is permission to begin testing, not evidence that the drug repairs myelin or improves people's health. As of 16 September 2026, no public study registration or participating centre had been found.

Read the update →Source: Quantum BioPharma — official company statement filed with the US SEC ↗
Research event/source date:
Emerging treatments + myelin repairLaboratory or animal researchPositive laboratory or animal findings, not clinical benefit

Laboratory and animal research

CN045 helped immature human cells mature and increased myelin repair in mice

Funder: US National Institutes of Health; National Multiple Sclerosis Society; Ohio Fast Forward

A paper in npj Drug Discovery described CN045, a molecule that can reach the brain and spinal cord. In the laboratory it helped immature human cells develop into cells that make myelin, and in mice it increased myelin repair.

Published by MyelinWatch:

What this means for people with MS

CN045 is an interesting possible drug, but it has not been tested in people. The molecule still needs improvement, safety checks and studies of how the body processes it.

Read the update →Source: npj Drug Discovery — peer-reviewed research article ↗
Research event/source date:
Emerging treatments + myelin repairResults from peopleLong-term safety observations; disability progressed

Retrospective follow-up of an open-label Phase 1 study

STEMS: long-term outcomes in 11 neural cell transplant recipients

Organisation: IRCCS San Raffaele Scientific Institute, Milan · Italy

A retrospective STEMS report published on 22 July 2026 follows 11 of the 12 original NCT03269071 recipients for a median 5.7 years after one injection of human fetal neural precursor cells into spinal fluid. Serious adverse events occurred but were judged unlikely related to the transplant. Median disability score EDSS rose from 7.25 before transplantation to 7.75 at two years and 8.5 at long-term follow-up. Median score on the cognition test SDMT was 38 at baseline, 49 at two years and 42 at long-term follow-up. Five of 11 had new or enlarged T2 MRI lesions without contrast enhancement.

Published by MyelinWatch:

What this means for people with MS

These are limited late-safety observations, not evidence that the intervention slowed disability or restored myelin. A lower gray-matter atrophy rate than in the first two years was an exploratory MRI observation. The small retrospective study had no concurrent randomized control, so it cannot show that the cells caused this difference or a benefit to patients. This remains an experimental intervention, not established treatment.

Read the update →Source: Stem Cell Research & Therapy / Springer Nature — peer-reviewed research article ↗Source: ClinicalTrials.gov — original STEMS Phase 1 ↗ Source: Nature Medicine — original STEMS report ↗
Research event/source date:
Myelin repairLaboratory or animal researchMixed findings

Mouse and brain-slice experiments before human testing

MMP-9 loss changed microglial responses but had little effect on remyelination in mice

Organisation: Acta Neuropathologica Communications

A study tested whether deleting matrix metalloprotease-9 (MMP-9) affects myelin injury and repair. In isolated brain slices, deficiency impaired repair through microglia/macrophage-related mechanisms. In the cuprizone mouse model, deficiency increased activated microglia/macrophages but had minimal impact on demyelination or remyelination. Proteomic and cell analyses pointed to altered inflammatory responses, not a demonstrated repair therapy.

Published by MyelinWatch:

What this means for people with MS

This helps map a complex repair-related pathway and cautions against assuming that suppressing MMP-9 will restore myelin. Mouse and slice findings cannot establish a treatment effect, safety, or benefit for people with MS. No approved clinical treatment has been shown to reliably restore myelin in MS.

Read the update →Source: Acta Neuropathologica Communications — peer-reviewed primary article ↗
Research event/source date:
Emerging treatments + myelin repairPlanned first study in peopleFDA: permission granted; first study not started

Planned Phase 1 study

PTD802: FDA permits a planned first study in people

Organisation: Pheno Therapeutics · Regulator: US Food and Drug Administration · United States

The FDA allowed a planned first study of PTD802 to proceed. The public listing reviewed here does not show that the study has started. PTD802 is an oral drug designed to help immature cells develop into cells that make myelin.

Published by MyelinWatch:

What this means for people with MS

Permission does not show that participants have received PTD802 or that it helps people with MS. This is not an available treatment.

Read the update →Source: Pheno Therapeutics — official company announcement ↗
Research event/source date:
Emerging treatmentsResults from peopleEU marketing authorisation for the specified SPMS indication

EU marketing authorisation issued on 19 June 2026

Cenrifki: EU authorises tolebrutinib for a defined secondary progressive MS group

Organisation: Sanofi Winthrop Industrie

The EMA record states that Cenrifki (tolebrutinib) received EU-wide marketing authorisation on 19 June 2026 for adults with secondary progressive multiple sclerosis who have had no relapses in the previous two years. This is the authorisation date, separate from the earlier CHMP opinion and later company announcements. In the Phase 3 HERCULES trial, 1,131 people were randomised to tolebrutinib or placebo; the peer-reviewed report found a lower risk of disability progression confirmed for at least six months with tolebrutinib (hazard ratio 0.69; 95% confidence interval 0.55–0.88).

Published by MyelinWatch:

What this means for people with MS

This is an EU authorisation for a specific adult population, not a general MS cure or evidence of myelin repair. It does not itself establish commercial availability or reimbursement in Greece. The EMA identifies liver injury as the main safety concern: liver function must be checked before and during treatment, and Cenrifki is under additional monitoring. The HERCULES study is complete; its trial status is separate from the medicine's authorisation.

Read the update →Source: European Medicines Agency — official EMA medicine record ↗Source: New England Journal of Medicine — original HERCULES trial, PMID 40202696 ↗ Source: ClinicalTrials.gov — HERCULES NCT04411641, completed with results posted ↗
Research event/source date:
Emerging treatments + myelin repairLaboratory or animal researchNo evidence of benefit in people yet

Laboratory and animal research

Rutgers advances new molecules that may help repair myelin

Organisation: Rutgers University · United States

Rutgers presented new small molecules that act on a receptor called mGluR5. They increased production of myelin proteins in human cells in the laboratory and showed activity in animal models.

Published by MyelinWatch:

What this means for people with MS

This is early research seeking a partner for further development, not a study in people. Researchers still need to select and improve the best candidate molecule.

Read the update →Source: Rutgers Innovation Ventures — university technology-transfer page ↗
Research event/source date:
Emerging treatments + myelin repairResults from peopleStudy stopped before a clear answer about whether it helps

Phase 3

RESTORE: the Phase 3 clemastine study stopped after an early review found it was unlikely to reach its goal

Study sponsor: Amsterdam UMC, location VUmc

RESTORE tested clemastine in people with MS and a disorder affecting eye movement. It was stopped after slow enrolment led to an early review, which found that the study was unlikely to reach its goal.

Published by MyelinWatch:

What this means for people with MS

This is an important negative development for this study. It should not be treated as a clear result about whether clemastine works, because the decision was made in a study that had serious difficulty finding participants.

Read the update →Source: ClinicalTrials.gov — official clinical-trial registry ↗
Research event/source date:
Emerging treatments + myelin repairRegistered study in peopleFirst patients enrolled and implanted; no results posted

Registered pilot study of a medical device in people; no results posted

SetPoint reports first patients enrolled and implanted in its MS pilot study

Organisation: SetPoint Medical

On 30 April 2026, SetPoint Medical announced that the first patients had enrolled and received implants in its pilot study for relapsing-remitting multiple sclerosis (MS). The device delivers electrical stimulation through an implant on the left vagus nerve, alongside continued standard disease-modifying treatment. The registry records the actual study start as 17 April 2026. In the registry update posted on 2 September 2026 and checked on 29 September, the study was accepting participants, with an estimated 60 participants and nine listed US sites. No results were posted. The April announcement is the event; the September dates refer to registry posting and verification.

Published by MyelinWatch:

What this means for people with MS

This milestone establishes that patients entered the study and received implants. It does not establish benefit to patients or myelin repair. Implantation involves surgery under anaesthesia. The device remains investigational and is not approved for MS; US approval for certain adults with rheumatoid arthritis is a different indication. The listed study sites are in the United States, with none listed in Greece at the registry check. Eligibility and site contact still determine participation. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Read the update →Source: SetPoint Medical — official company announcement ↗Source: ClinicalTrials.gov — NCT06796504; registry update posted 2 September 2026 ↗
Research event/source date:
Emerging treatments + myelin repairResults from peopleNo clear effect found

Phase 2

ReWRAP: Phase 2 found no statistically significant improvement in the study's measures of myelin repair

In ReWRAP, bazedoxifene was generally well tolerated. However, it did not show a clear improvement in either the main MRI measure of myelin or the study's other measures of whether the treatment worked.

Published by MyelinWatch:

What this means for people with MS

Another drug with strong results in laboratory and animal research did not show a clear sign of myelin repair in people in Phase 2.

Read the update →Source: ClinicalTrials.gov / ACTRIMS 2026 — official ClinicalTrials.gov record ↗
Research event/source date:
Emerging treatments + myelin repairLaboratory or animal researchPositive laboratory or animal findings, not clinical benefit

Laboratory and animal research

Bavisant / BRAVEinMS shows promising myelin repair and nerve protection in several experimental models

Organisation: Vita-Salute San Raffaele University and IRCCS San Raffaele Scientific Institute · Italy

After testing more than 1,500 existing compounds, researchers found that bavisant showed signs of myelin repair and nerve protection in several models. These included human cells in the laboratory and mice containing some human cells.

Published by MyelinWatch:

What this means for people with MS

This is one of the more promising new candidates among existing drugs, but it has not been tested in people with MS and no benefit to patients has been shown.

Read the update →Source: PubMed / Science Translational Medicine — peer-reviewed paper ↗
Research event/source date:
Emerging treatments + myelin repairLaboratory or animal researchPositive laboratory or animal findings, not clinical benefit

Laboratory and animal research

DITPA / Petratos: early results suggest nerve protection and myelin repair in mice

Organisation: Monash University · Australia

Steven Petratos's team reported that daily DITPA by mouth reduced neurological decline, helped myelin-making cells survive, reduced damage to myelin and nerve fibres, and improved related measurements in mice.

Published by MyelinWatch:

What this means for people with MS

This is an active and serious research programme, but there is no publicly registered study in people with MS. Results in mice are not evidence of benefit in people.

Read the update →Source: Research Square / Monash University — research preprint ↗
Research event/source date:
Emerging treatments + myelin repairResults from peopleDid not show the hoped-for effect

Phase 2

PIPE-307: the Phase 2 VISTA study did not show the hoped-for benefit

Organisation: Contineum Therapeutics · United States

In relapsing-remitting MS, PIPE-307 had acceptable safety and tolerability, but it did not reach the study's main or secondary measures of benefit.

Published by MyelinWatch:

What this means for people with MS

One of the most discussed drugs designed specifically to repair myelin did not show benefit in Phase 2. It is uncertain whether development for MS will continue.

Read the update →Source: Contineum Therapeutics — official company statement filed with the US SEC ↗
Research event/source date:
Emerging treatments + myelin repairResults from peoplePromising early finding

Phase 2a

CCMR Two: promising biological sign of myelin repair with metformin plus clemastine

Organisation: Cambridge Clinical MS Research Group · United Kingdom

After 24 weeks, metformin plus clemastine shortened the delay in the brain's electrical response to vision, a change consistent with myelin repair. Vision and disability did not improve during the study's short follow-up.

Published by MyelinWatch:

What this means for people with MS

This is one of the stronger early findings in people, but it does not yet show that the treatment improves symptoms or reverses disability.

Read the update →Source: Cambridge Clinical MS Research Group — official academic research-group update ↗