INDEPENDENT RESEARCH MONITOR

Studies & programmes

The combined catalogue for both research tracks.

A programme that belongs to both emerging treatments and myelin repair appears once, with both labels.

Newest MyelinWatch publications first; research-event dates are labelled separately.

How the research sections relate

Emerging treatmentsTherapeutic developments for MS broadly — not only myelin repair.Myelin repairResearch specifically aimed at remyelination or repairing myelin.
Studies & programmesThe combined catalogue containing both tracks; dual-track programmes appear once.

results

Organisation: Sanofi · France

Emerging treatmentsLarge study to confirm benefit and safetyAccepting participants

Frexalimab: an experimental anti-CD40L antibody in Phase 3 studies for MS

Published by MyelinWatch:

What is being studied

Frexalimab (SAR441344) is an experimental antibody from Sanofi that blocks CD40 ligand (CD40L), a molecule that helps immune cells activate one another. It is given into a vein or as an injection under the skin. Phase 3 studies compare it with teriflunomide in relapsing MS (FREXALT) and with placebo in non-relapsing secondary progressive MS (FREVIVA); a smaller Phase 3 study, Frexcite, compares the two ways of giving it.

Research stage

Large study to confirm benefit and safety

The current listing is open to participants.

What we know so far

In a Phase 2 study in 129 people with relapsing MS, published in the New England Journal of Medicine in 2024, people on frexalimab had fewer new active (gadolinium-enhancing) brain lesions on MRI at week 12 than people on placebo: on average 0.2 with the higher dose into a vein and 0.3 with the lower dose under the skin, against 1.4 with placebo (rate ratios 0.11 and 0.21). This is an MRI measure over a short period in a small study, not proof that relapses or disability are reduced. No Phase 3 results are available yet.

What this means for patients today

Frexalimab is not an approved treatment; it is given only within studies. FREXALT and FREVIVA list sites in Greece but are no longer accepting new participants. The smaller Phase 3 study Frexcite is listed as accepting participants in some countries, with no site in Greece. The long-term extension study, authorised in 11 EU countries, including Greece on 2 November 2026, is only for people who complete earlier frexalimab studies, and it has not started accepting participants. Access to frexalimab in Greece outside these studies is not established.

Related dated updates

Organisation: The Lancet

Emerging treatmentsLarge study to confirm benefit and safetyOngoing, not accepting participants

REMODEL: remibrutinib in relapsing MS

Published by MyelinWatch:

What is being studied

Two separate Phase 3 trials compared oral remibrutinib, which inhibits the immune-signalling enzyme BTK, with teriflunomide in adults with active relapsing MS. REMODEL is not the REMASTER SPMS study.

Research stage

Large study to confirm benefit and safety

The study continues without taking new participants.

What we know so far

In both trials the annualised relapse rate was lower with remibrutinib. The abstract reports 2,007 randomised adults and common adverse events, but the full article and safety appendix were not reviewed; disability outcomes require separate assessment.

What this means for patients today

These are group-level results against one comparator, not a personalised treatment recommendation. Both trials are active without new recruitment. Generic Greek registry location rows do not prove an available study place or Greek medicine access.

Related dated updates

Organisation: ClinicalTrials.gov

Emerging treatmentsStudy in peopleResearch, not an established treatment

Refractory-MS AHSCT protocol NCT06228781

Published by MyelinWatch:

What is being studied

The sponsor proposes immune-suppressing treatment followed by reinfusion of a person's own blood-forming stem cells (AHSCT) for refractory MS, with a small target enrollment.

Research stage

Study in people

The study is not yet accepting participants.

What we know so far

The registry describes a planned transplant study that is not yet accepting participants; the cited record has no posted participant or outcome data.

What this means for patients today

This registry entry does not provide a currently joinable study or justify a treatment choice.

Organisation: ClinicalTrials.gov

Emerging treatmentsFirst study in people — mainly checks safetyOngoing, not accepting participants

P-CD19CD20-ALLO1 donor-cell study in progressive and relapsing MS

Published by MyelinWatch:

What is being studied

The trial tests donor-derived CD19/CD20-targeted cells in relapsing and progressive MS, focusing on safety and cell behaviour.

Research stage

First study in people — mainly checks safety

The study continues without taking new participants.

What we know so far

The Phase 1 registry protocol is ongoing without accepting new participants; the cited record has no posted results.

What this means for patients today

Experimental cell therapy, not a proven or currently joinable study in this record; no Greek site is listed.

Organisation: ClinicalTrials.gov

Emerging treatmentsFirst study in people — mainly checks safetyAccepting participants

KITE-363 early cell-therapy study including MS

Published by MyelinWatch:

What is being studied

KITE-363 uses a person's own T cells, modified to recognise B cells carrying CD19 or CD20, in a study of refractory autoimmune neurological diseases including MS.

Research stage

First study in people — mainly checks safety

The current listing is open to participants.

What we know so far

The Phase 1a/1b registry entry says the study is accepting participants; that entry has no posted results.

What this means for patients today

It is a study, not an available proven MS treatment; places and eligibility must be confirmed with the team.

Organisation: ClinicalTrials.gov

Emerging treatmentsPhase 1/2 study in people — safety and possible benefitResearch, not an established treatment

CTX112 donor-derived CAR-T study including progressive MS

Published by MyelinWatch:

What is being studied

The trial plans to test donor-derived CD19 CAR-T cells in adults with refractory neurological autoimmune disease, including progressive MS.

Research stage

Phase 1/2 study in people — safety and possible benefit

The study is not yet accepting participants.

What we know so far

The combined Phase 1/2 protocol is registered but not yet accepting participants. The registry does not establish actual enrolment or exposure and has no posted results.

What this means for patients today

This is not an available MS treatment. The study is not yet accepting participants; no Greek site or individual eligibility is established.

Organisation: ClinicalTrials.gov

Emerging treatmentsLarge study to confirm benefit and safetyAccepting participants

BEAT-MS: AHSCT versus best available therapy in resistant relapsing MS

Published by MyelinWatch:

What is being studied

BEAT-MS compares an AHSCT strategy—intensive immune suppression followed by a person's own blood-forming stem cells—with best available disease-modifying therapy in resistant relapsing MS.

Research stage

Large study to confirm benefit and safety

The current listing is open to participants.

What we know so far

The Phase 3 registry protocol compares two approaches and lists the study as accepting participants; the cited registry record has no posted outcome results.

What this means for patients today

This comparison does not yet tell an individual whether transplantation would help. Eligibility and current places belong to the study team; AHSCT risks need specialist discussion.

Organisation: TG Therapeutics · United States

Emerging treatmentsPhase 1 study evidenceCurrent human-study status unknown

Azer-cel: donor-derived CAR T cells in progressive MS

Published by MyelinWatch:

What is being studied

TG-Azercel-101 studies azer-cel (azercabtagene zapreleucel), donor-derived CAR T cells designed to target CD19-positive B cells in progressive multiple sclerosis (MS). Participants receive one infusion after bendamustine lymphodepletion. This Phase 1 study chiefly assesses safety and early biological and clinical measures.

Research stage

Phase 1 study evidence; current human-study status is unknown

The programme is listed as active; current human-study status is unknown.

What we know so far

Initial conference data cover 26 treated people, with median follow-up of 4.9 months at the 3 September 2026 cutoff. EDSS was 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 defined high-grade CAR-T toxicities were reported. These are descriptive results without a comparator.

What this means for patients today

Azer-cel remains investigational for MS. Disability and MRI observations cannot prove benefit, and the small group and short follow-up cannot establish broad safety. The sponsor reports ongoing dose escalation, but official recruitment status is unverified. Greek availability and reimbursement are unverified.

Related dated updates

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

Emerging treatmentsPhase 3 study in peopleEU authorised

Ocrevus for children aged 10 and older with active relapsing MS

Published by MyelinWatch:

What is being studied

Ocrelizumab reduces CD20-positive B cells. The paediatric programme studied intravenous treatment in children and adolescents with active relapsing multiple sclerosis (MS), including Phase 3 OPERETTA 2 versus fingolimod.

Research stage

Phase 3 study in people

EU-authorised indication; the supporting study continues without new participants.

What we know so far

The European Commission extended the indication on 15 October 2026. The regulatory decision is supported by paediatric human evidence, but is not a new trial result. OPERETTA 2 is active, not recruiting; its posted results are a separate fact. The EMA safety communication of 8 October concerns drug-induced liver injury of unknown frequency and recommends liver-function monitoring.

What this means for patients today

The indication applies to eligible patients aged 10 or older under specialist care. It does not establish Greek access or reimbursement, individual eligibility, superiority, or myelin repair.

Related dated updates

Organisation: Neurology and Therapy

Emerging treatmentsCompleted human studyStudy completed

Aging: cladribine tablets in people 50 and older

Published by MyelinWatch:

What is being studied

The US Aging study observed people aged 50 or older with relapsing multiple sclerosis (MS) after starting cladribine tablets, which reduce selected immune-cell populations. It was a 24-month Phase 4 observational study without a comparator.

Research stage

Completed human study

Follow-up completed; results published

What we know so far

Among 115 participants, the observed annualised relapse rate was 0.07 over 24 months. Adverse events occurred in 69.6%, serious adverse events in 7.0%, and lymphopenia in 44.3%. Only 31 participants were 65 or older. These are descriptive observations.

What this means for patients today

The findings may inform clinical discussion but cannot prove effectiveness or comparative safety. Patient selection, retention and incomplete imaging limit interpretation. The US paper does not establish Greek access or reimbursement.

Related dated updates

Organisation: IRCCS San Raffaele Scientific Institute, Milan · Italy

Myelin repairPhase 1 study evidenceCurrent status unknown

STEMS: neural precursor cell transplantation in progressive MS

Published by MyelinWatch:

What is being studied

STEMS tested one injection into the spinal fluid of human fetal neural precursor cells in 12 people with progressive multiple sclerosis (MS). Researchers are exploring whether these cells could support nerve tissue and repair processes; the study was primarily designed to assess feasibility and safety.

Research stage

Phase 1 study evidence; current programme status is unknown

Current programme and human-study status are unknown.

What we know so far

The original open-label Phase 1 study treated 12 people. A July 2026 retrospective report describes 11 of them after a median 5.7 years. Serious adverse events occurred but were judged unlikely related to the transplant. Disability worsened: median EDSS rose from 7.25 before treatment 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. The long-term SDMT score did not differ statistically from baseline but was lower than at two years. A lower gray-matter atrophy rate than in the first two years is exploratory imaging evidence, not demonstrated clinical benefit or remyelination.

What this means for patients today

This is an experimental cell intervention, not an established treatment for MS. The small uncontrolled follow-up cannot show that transplantation slowed disability or restored myelin. The old Phase 1 registry is completed. In their July 2026 paper, the authors reported conducting a separate Phase 2 study, but its current enrolment and access have not been independently verified. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Related dated updates

Study sponsor: Novartis

Emerging treatmentsLarge study to confirm benefit and safetyAccepting participants

REMASTER: remibrutinib is being studied in secondary progressive MS

Published by MyelinWatch:

What is being studied

REMASTER is a Phase 3 study testing whether the oral drug remibrutinib is effective and safe for people with secondary progressive multiple sclerosis (MS). Participants are assigned to remibrutinib or placebo in the blinded main part of the study.

Research stage

Large study to confirm benefit and safety

The current listing is open to participants.

What we know so far

The EU CTIS record, last checked on 25 October 2026, reported Greek country recruitment starting 18 September and named seven centres. The ClinicalTrials.gov update posted 13 October lists REMASTER overall as accepting participants and six Greek location rows labelled only “Novartis Investigative Site”. No results are posted in that REMASTER ClinicalTrials.gov record. Recruitment and location information do not establish benefit, safety or myelin repair in MS.

What this means for patients today

A person with secondary progressive MS may wish to discuss REMASTER because it tests whether remibrutinib can delay disability progression; taking part helps answer that question. No REMASTER results are posted, and the blinded main part assigns participants to remibrutinib or placebo, so neither receiving the experimental drug nor personal benefit is assured. At the 25 October CTIS check, Greece was listed as accepting participants and seven centres were named, but the relevant centre must confirm current enrolment and eligibility; no available place is guaranteed. Study participation is not approved treatment access, and Greek commercial availability or reimbursement for this use is not established.

Related dated updates

Study sponsor: RenJi Hospital / CAR-AID; separate NCT07825389 sponsor AbelZeta

Emerging treatmentsResults from studies in people are availableResearch, not an established treatment

C-CAR168: experimental CAR-T cells studied in progressive MS

Published by MyelinWatch:

What is being studied

C-CAR168 uses a person's own T cells engineered to target CD20 and BCMA, markers on B cells and plasma cells. A separate US Phase 1b/2 study is planned to examine safety and whether it helps people with treatment-refractory progressive multiple sclerosis (MS), including secondary and primary progressive MS; it has no posted results.

Research stage

Results from studies in people are available

The study is not yet accepting participants.

What we know so far

A peer-reviewed CAR-AID case report describes two people with treatment-refractory secondary progressive MS after C-CAR168. Disability scores changed from 4.0 to 3.0 over 12 months and from 6.5 to 6.0 over 6 months; MRI and immune measures also changed. These two uncontrolled cases cannot show that C-CAR168 caused improvement. Mild adverse events, including grade 1 cytokine-release syndrome, were reported; long-term safety is unknown. The separate US Phase 1b/2 study NCT07825389 has no results posted.

What this means for patients today

C-CAR168 remains experimental. The published cases cannot establish whether it helps people, repairs myelin, or is safe in the long term. The US NCT07825389 study was listed as not yet accepting participants in its 13 October 2026 update; its estimated February 2027 start is a plan, not evidence it has begun. No Greek study site, treatment availability, or reimbursement is established.

Related dated updates

Study sponsor: Cellerys AG

Emerging treatmentsPhase 1 study in peopleStudy completed

RED4MS: teaching the immune system tolerance with modified red blood cells

Published by MyelinWatch:

What is being studied

RED4MS studied CLS12311, made from a person's own red blood cells coupled to peptides, as a way to promote antigen-specific immune tolerance in relapsing multiple sclerosis (MS). A separate phase Ib study reported in PNAS in August 2026 also examined peptide-coupled red blood cells; it is a different cohort, not RED4MS. The 7 October 2026 Science Advances paper investigates how the approach works in EAE mice.

Research stage

Phase 1 study in people

NCT06430671 is completed; current broader programme status is not established

What we know so far

The registered RED4MS study NCT06430671 is completed. The registry lists 11 enrolled; 9 received CLS12311, and summary results were first posted on 8 June 2026. Cellerys's RED4MS lay summary reports generally good tolerability across the tested doses, mostly mild adverse events, one serious event judged unrelated to treatment, and two MS relapses judged unrelated. This small safety study cannot establish whether CLS12311 prevents MS activity. Separately, the PNAS phase Ib paper reports tolerability observations and changes in antigen-specific regulatory T cells; those findings belong to its own cohort and do not establish benefit for people with MS. The October Kupffer-cell finding is from mice. The current status of the broader programme is unknown.

What this means for patients today

CLS12311 remains an investigational approach, not an established available MS treatment. The small early human study does not show reliable benefit for people with MS, and the mouse mechanism does not establish human benefit, safety or myelin repair. The completed trial is not accepting participants. Access or reimbursement in Greece is not established.

Related dated updates

Study sponsor: F. Hoffmann-La Roche Ltd

Emerging treatmentsPhase 3 study in peopleStudy completed

OPERA I and II: what 10 years of ocrelizumab follow-up show

Published by MyelinWatch:

What is being studied

The OPERA I and II Phase 3 trials studied ocrelizumab, an antibody that depletes CD20-positive B cells, in adults with relapsing multiple sclerosis (MS). For the first two years, participants were randomized to ocrelizumab or interferon beta-1a. Those entering the open-label extension then received ocrelizumab for up to eight more years. The October 2026 paper analyzes this follow-up after the trials ended.

Research stage

Phase 3 study in people

NCT01247324 and NCT01412333 are completed; any broader current programme status is not established

What we know so far

Of 1,656 originally randomized participants, 853 completed the studies. Across ten years, the earlier-ocrelizumab group had a lower hazard of 48-week confirmed disability progression than the group that started on interferon and later switched (hazard ratio 0.76; 95% confidence interval 0.61–0.95). The difference arose largely in the initial randomized period; the extension-only comparison was not significant (hazard ratio 1.02; 95% confidence interval 0.81–1.28). The comparison for progression independent of relapse activity (PIRA) was also not significant. Serious infections and lower IgG levels occurred despite no rising overall observed adverse-event rates in the extension.

What this means for patients today

The findings inform long-term discussions about treatment timing in relapsing MS, but they do not show ten years of randomized treatment comparison, an individual treatment recommendation, myelin repair or benefit in primary progressive MS. Attrition, open-label follow-up and post hoc analysis limit interpretation. The paper itself does not establish access or reimbursement in Greece.

Related dated updates

Organisation: University of California, San Francisco research team

Emerging treatmentsFirst study in people — mainly checks safetyOngoing, not accepting participants

miv-cel (KYV-101): experimental CAR-T cells tested in two people with progressive MS

Published by MyelinWatch:

What is being studied

miv-cel is made from a person’s own T cells, engineered to target CD19-positive B cells. An early Phase 1 study is testing whether this immune-cell approach can be given to people with treatment-refractory progressive multiple sclerosis (MS). Participants received chemotherapy conditioning before the CAR-T infusion.

Research stage

First study in people — mainly checks safety

The study continues without taking new participants.

What we know so far

A September 2026 preprint describes two treated women with secondary progressive MS. CAR-T cells appeared in cerebrospinal fluid and exploratory immune markers changed. MRI findings were stable and disability scores changed, but these uncontrolled observations do not show that miv-cel improved MS. Reported high-grade adverse effects and laboratory abnormalities included grade 3 liver-enzyme elevation, neutropenia and lymphopenia in participant 1 and grade 4 lymphopenia in participant 2. Participant 1 also had low immunoglobulin requiring replacement and a delayed rash; participant 2 had grade 1 cytokine-release syndrome treated with tocilizumab and dexamethasone. Conditioning chemotherapy may have contributed to blood-count changes. The preprint has not been peer reviewed.

What this means for patients today

This remains an experimental Phase 1 intervention, not an available or proven MS treatment. ClinicalTrials.gov lists NCT06451159 as active but not accepting new participants, while the paper says further recruitment stopped after Kyverna, a study collaborator, shifted its development focus. There is no established Greek study site or access, and no evidence of myelin repair.

Related dated updates

Organisation: Ramesan et al. research team

Myelin repairNot tested in peopleResearch, not an established treatment

Human cell spheroids: a laboratory model of myelin injury and repair

Published by MyelinWatch:

What is being studied

Researchers grew three-dimensional tissue spheres from human induced pluripotent stem cells, including myelin-producing oligodendrocytes and microglia. They induced myelin injury to study how human cells clear debris and form new myelin around nerve fibres, a process relevant to multiple sclerosis (MS).

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

The peer-reviewed paper reports myelin fragmentation, microglial uptake of debris, 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. This is evidence that the cell model reproduces selected repair processes. It does not reproduce every feature of adult MS and has no patient outcome.

What this means for patients today

No person with MS was treated in this study. The model may help future research and early screening of candidate compounds, but it is not a therapy, a clinical trial or proof of remyelination in patients. It creates no established treatment access in Greece.

Related dated updates

Organisation: Sanofi Winthrop Industrie

Emerging treatmentsPhase 3 study in peopleEU authorised

Cenrifki (tolebrutinib): EU-authorised treatment for a defined secondary progressive MS group

Published by MyelinWatch:

What is being studied

Tolebrutinib is an oral drug that blocks Bruton’s tyrosine kinase (BTK), an enzyme involved in immune-cell signalling. The Phase 3 HERCULES study compared it with placebo in people with secondary progressive MS without relapses. Cenrifki is the medicine name under which tolebrutinib is authorised in the EU for adults with secondary progressive MS who have had no relapses in the previous two years.

Research stage

Phase 3 study in people

EU-authorised for adults with SPMS without relapses in the previous two years; HERCULES completed

What we know so far

HERCULES randomised 1,131 people. Its peer-reviewed report found a lower risk of disability progression confirmed for at least six months with tolebrutinib than with placebo (hazard ratio 0.69; 95% confidence interval 0.55–0.88). The study is completed and results are posted in the official registry. The EMA identifies liver injury as the main safety concern; liver tests are required before and during treatment, and the medicine is under additional monitoring.

What this means for patients today

The EU marketing authorisation is real but applies only to the stated adult SPMS group. It does not by itself establish whether Cenrifki is commercially available or reimbursed in Greece. Treatment requires a prescription and supervision by a doctor experienced in MS; the liver precautions are part of the authorised use. This is not evidence that the medicine restores myelin or cures MS.

Related dated updates

Organisation: Sundance Biosciences Inc.

Emerging treatmentsTesting whether it helps patientsAccepting participants

SUN-627: an experimental immune-targeting drug being studied in progressive MS

Published by MyelinWatch:

What is being studied

SUN-627 is an oral drug that Sundance Biosciences describes as a brain-penetrant inhibitor of TYK2, an enzyme involved in immune signalling. A registered Phase 2a study compares two once-daily dose levels with placebo in adults with primary progressive or non-active secondary progressive MS. It chiefly measures safety over 16 weeks; it also measures drug exposure and neuroinflammation biomarkers.

Research stage

Testing whether it helps patients

The current listing is open to participants.

What we know so far

ClinicalTrials.gov lists the overall study and three US locations as open to participants, with an estimated October 2026 start and 20 planned participants. No results for NCT07840326 are posted. The listed status does not confirm actual start or dosing. The sponsor's mechanism description is not evidence of clinical benefit. Separately, the EU Clinical Trials Information System records SUN-627-MS201 (EUCT 2026-525817-29-00), a Phase 2a study in Finland. Finland authorised that study on 5 June 2026; its 18 June 2026 registry update listed recruitment as pending and showed no actual start date. This is the status shown in a registry record last updated on 18 June, not proof that recruitment or dosing has begun in practice. No MS201 results were shown in the reviewed record.

What this means for patients today

SUN-627 is an experimental study drug, not an available treatment. This registry record lists three US sites and no Greek site; current registry contacts give the study's eligibility details. The record does not establish benefit for symptoms or disability, or myelin repair. The separate Finnish MS201 record listed Finland only at its 18 June 2026 update; it does not establish a Greek study site or treatment access. The registry does not establish whether recruitment or dosing has actually begun.

Related dated updates

Organisation: Roche

Emerging treatmentsLarge study to confirm benefit and safetyOngoing, not accepting participants

Fenebrutinib: an experimental oral BTK inhibitor under US review for MS

Published by MyelinWatch:

What is being studied

Fenebrutinib is an oral drug that blocks Bruton’s tyrosine kinase (BTK), an enzyme involved in immune-cell signalling. Three Phase 3 studies tested it in relapsing MS or primary progressive MS: FENhance 1 and 2 compared it with teriflunomide, while FENtrepid compared it with ocrelizumab.

Research stage

Large study to confirm benefit and safety

The study continues without taking new participants.

What we know so far

Roche reported 51.1% and 58.5% lower annualised relapse rates than teriflunomide in FENhance 1 and 2 over 96 weeks. Disability findings in those studies were favourable trends, not established superiority on disability. FENtrepid met its noninferiority comparison with ocrelizumab for disability progression: it was not worse by more than the study's pre-set margin (hazard ratio 0.88; 95% confidence interval 0.75–1.03). This does not establish superiority. Roche also reported more liver-enzyme elevations with fenebrutinib in FENtrepid and an imbalance in the number of deaths between treatment arms across the trials. These are sponsor-reported results, and the safety findings need careful assessment.

What this means for patients today

According to Roche, the FDA accepted a US new drug application for Priority Review on 30 September 2026. This is a review step, not approval or proof of availability. The cited sources do not establish authorisation or access in Greece. The three cited trials are listed as active but not accepting new participants.

Related dated updates

Study sponsor: Zenas BioPharma (USA), LLC

Emerging treatmentsLarge study to confirm benefit and safetyGreek status differs by study

Orelabrutinib: Phase 3 studies in two forms of progressive MS

Published by MyelinWatch:

What is being studied

Orelabrutinib is an experimental drug designed to inhibit BTK, a protein involved in immune-cell signalling. Zenas BioPharma (USA), LLC sponsors studies of orelabrutinib in primary progressive MS (NCT07067463) and non-active secondary progressive MS (NCT07299019). The studies assess whether treatment affects disability worsening.

Research stage

Large study to confirm benefit and safety

The two trial records list overall recruitment; Greek country participation differs by study and is explained below.

What we know so far

ClinicalTrials.gov lists both Phase 3 studies overall as accepting participants, with about 705 and 990 planned participants and no posted results (both records updated 27 October 2026). At the 25 October CTIS check, Greece was listed as accepting participants for PriMroSe, with seven Greek site listings. For Monarch, the EU register (Greek entry last updated 16 October) still listed Greek recruitment as pending at the 28 October check, with six Greek site listings, while the ClinicalTrials.gov record now lists an Athens centre, recorded as "Errikos Dunant Hospital" and matching the Henry Dunant Hospital Center, as accepting participants. The two registers were updated on different dates. Neither source establishes benefit, safety, myelin repair, an available place or individual eligibility at a Greek centre.

What this means for patients today

A person with primary progressive MS may wish to discuss PriMroSe because it tests whether orelabrutinib can delay disability progression; taking part helps answer that question. No PriMroSe results are posted, and participants are assigned to orelabrutinib or placebo, so neither receiving the experimental drug nor personal benefit is assured. At the 25 October CTIS check, Greece was listed as accepting participants for PriMroSe. A person with non-active secondary progressive MS may wish to ask about the separate Monarch study, which also compares orelabrutinib with placebo and has no posted results: ClinicalTrials.gov lists an Athens centre, recorded as "Errikos Dunant Hospital" (the Henry Dunant Hospital Center), as accepting participants, although the EU register still listed Greek recruitment as pending at the last update of its Greek entry (16 October). An individual centre must confirm current enrolment and eligibility; study access is not approved treatment or evidence of Greek commercial availability or reimbursement. No established approved treatment has been proven to reliably restore myelin in MS.

Related dated updates

Myelin repairTesting whether it helps patientsOngoing, not accepting participants

TOTEM-RRMS: EU register records the end of recruitment in testosterone study

Published by MyelinWatch:

What is being studied

TOTEM-RRMS is a Phase 2 study testing testosterone in men with relapsing-remitting MS and low testosterone. MRI scans and clinical measures assess possible effects on nerve protection and myelin.

Research stage

Testing whether it helps patients

The study continues without taking new participants.

What we know so far

At the 28 October 2026 check, the EU register (CTIS) listed the study as ongoing with recruitment ended, and recorded the end of recruitment in France on 29 June 2026. ClinicalTrials.gov, last updated 29 June 2025, before that date, still says the study is accepting participants. No study results are posted.

What this means for patients today

According to the EU register, the study is no longer enrolling new participants, and it had no centre in Greece. Testosterone is not an established MS treatment.

Myelin repairPhase 1/2 study in people — safety and possible benefitAccepting participants

PRO-1562: an early study seeking participants for a possible myelin-repair drug

Published by MyelinWatch:

What is being studied

The registered study plans a Phase 1 part with single doses in healthy adults to assess safety and drug exposure, followed by a Phase 2a part in adults with relapsing MS and chronic optic neuropathy to examine safety and possible effects on myelin and symptoms. Myelin repair is a study objective, not a demonstrated effect.

Research stage

Phase 1/2 study in people — safety and possible benefit

The current listing is open to participants.

What we know so far

ClinicalTrials.gov lists the overall NCT07826689 study and one Adelaide, Australia site as accepting participants. Its start remains estimated for October 2026 and no results are posted. The status does not establish that anyone has enrolled or received PRO-1562 or that the later MS part is open.

What this means for patients today

This is an experimental study, not an available treatment. The registry offers an Australian contact for eligibility, but does not show benefit or access in Greece. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Related dated updates

Myelin repairPhase 1/2 study evidenceStatus records conflict

MODIF-MS: ifenprodil study with conflicting status records

Published by MyelinWatch:

What is being studied

MODIF-MS is a Phase 1/2 study testing ifenprodil, which changes signalling through NMDA receptors, in people with multiple sclerosis.

Research stage

Phase 1/2 study evidence; current programme status is unknown

Current programme and human-study status are unknown.

What we know so far

The CTIS summary lists a temporary halt, while site-level information has indicated that the study may still be accepting participants. I could not independently confirm the current CTIS details; no result establishing benefit is available, and a possible restart is unconfirmed.

What this means for patients today

The conflicting records do not confirm whether the study is accepting participants now. Ifenprodil is not an established MS treatment.

Emerging treatmentsNo clinical study in MS is establishedResearch, not an established treatment

Kamuvudine-9 (K-9): MS findings so far are from mice

Published by MyelinWatch:

What is being studied

Researchers tested K-9, a modified nucleoside that blocks an inflammation-related cell alarm, in a mouse model of MS. The experiments examined vision, movement, nerve cells and myelin.

Research stage

No clinical study in MS is established

For MS, findings are from animal models; the human K-9 eye-disease study does not establish a clinical study in MS.

What we know so far

The paper reports recovery of some existing vision and movement problems in mice and protection of nerve cells and myelin. This is animal evidence. Separate insurance analyses found associations involving other NRTI medicines; those are not studies of K-9 and do not show that K-9 works in people with MS. K-9 has also been studied in eye disease, which does not establish an MS study.

What this means for patients today

K-9 is not an MS treatment. No clinical study of K-9 for MS is established, and the animal findings do not show benefit in people.

Related dated updates

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

Myelin repairPhase 2 study evidenceCurrent status unknown

MSC-NP cells: an experimental approach for progressive MS

Published by MyelinWatch:

What is being studied

Researchers studied neural precursor cells made from a person’s own bone-marrow cells and delivered into spinal fluid, with the aim of supporting repair in progressive MS.

Research stage

Phase 2 study evidence; current programme status is unknown

Current programme and human-study status are unknown.

What we know so far

A published analysis of two groups reported changes in spinal-fluid biomarkers. Those changes do not establish clinical benefit, and the current programme status is unknown.

What this means for patients today

This is an experimental cell approach, not an available treatment. The publication does not show that it improves symptoms or disability. The specific expanded-access pathway NCT03822858 is no longer available according to its registry record. This does not establish that the separate Phase 2 study NCT03355365 or the whole MSC-NP programme has closed; the overall programme status remains unknown.

Related dated updates

Organisation: SetPoint Medical

Myelin repairStudy in peopleAccepting participants

SetPoint MS Pilot: testing an implanted nerve-stimulation device

Published by MyelinWatch:

What is being studied

The study tests a device that applies electrical pulses to the left vagus nerve, which carries signals between the brain and internal organs. It investigates whether changing nerve signals can influence immune activity and support myelin repair in relapsing-remitting MS. The device is implanted surgically under anaesthesia, while participants continue standard disease-modifying treatment.

Research stage

Study in people

The current listing is open to participants.

What we know so far

SetPoint Medical reported the first patients enrolled and implanted on 30 April 2026. The registry records an actual start on 17 April and, in its update posted on 2 September, lists the pilot as accepting participants with an estimated 60 participants. Assignment is random, with two participants allocated to active stimulation for every one allocated to a sham setting, in a blinded study. The main safety measure counts adverse events through week 96. Other exploratory measurements at week 48 include electrical responses in the visual pathway (VEP P100 latency) and a magnetic resonance imaging (MRI) measure of tissue properties called magnetisation transfer ratio (MTR). No results are posted. These measurements alone do not establish patient benefit or myelin repair.

What this means for patients today

Use for MS remains investigational and unapproved. Entering a study or receiving an implant does not show that it works. US approval for certain adults with rheumatoid arthritis concerns a different indication. The registry checked on 29 September lists nine US sites and none in Greece; participation still depends on eligibility and direct site contact. No established approved treatment in clinical practice has been proven to reliably restore myelin in MS.

Related dated updates

Myelin repairNot tested in peopleResearch, not an established treatment

Scripps/Lairson: testing a two-molecule combination in models

Published by MyelinWatch:

What is being studied

Researchers combined two small molecules because together they increased myelin repair in experimental models. The combination is still at an early development stage.

Research stage

Not tested in people

Work remains in the laboratory and product development; a first safety study is planned.

What we know so far

The reported effect is from laboratory and animal models only. No benefit in people with MS has been shown.

What this means for patients today

This combination is not a treatment. More development and safety checks are needed before a human study could be considered.

Organisation: Rutgers University · United States

Myelin repairNot tested in peopleResearch, not an established treatment

Rutgers: testing molecules that activate mGluR5

Published by MyelinWatch:

What is being studied

Researchers are developing small molecules that activate mGluR5, a receptor involved in signalling that may influence myelin-making cells.

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

Activity has been reported in human myelin-making cells and animal models. The work remains at the laboratory-and-animal research stage; no benefit in people with MS is known.

What this means for patients today

These molecules are not treatments. A development partner and further work are still needed before human testing.

Related dated updates

Myelin repairPhase 2 study in peopleStudy completed

ReWRAP: completed Phase 2 study did not meet its myelin-repair measures

Published by MyelinWatch:

What is being studied

ReWRAP tested bazedoxifene as a possible way to affect cells involved in myelin repair. The Phase 2 study has finished.

Research stage

Phase 2 study in people

The study's main and secondary measures of myelin repair were not reached

What we know so far

The study did not meet its primary or secondary myelin-repair measures and found no clear benefit on those measures. It was generally well tolerated; the result does not establish benefit.

What this means for patients today

ReWRAP did not show the hoped-for effect on its planned measures. It is not an available treatment for myelin repair.

Related dated updates

Myelin repairPhase 1/2 study in people — safety and possible benefitAccepting participants

ReVIVE: studying clemastine in chronic myelin loss

Published by MyelinWatch:

What is being studied

Researchers are testing clemastine in people with long-term myelin loss, using MRI measures to look for possible changes.

Research stage

Phase 1/2 study in people — safety and possible benefit

The current listing is open to participants.

What we know so far

This Phase 1/2 study is currently open to participants at UCSF. Results are awaited; MRI signals would not by themselves prove better symptoms or function.

What this means for patients today

This is an ongoing study, not an available treatment. The listed centre is in the United States, and eligibility must be checked with the study team.

Study sponsor: Amsterdam UMC, location VUmc

Myelin repairPhase 3 study in peopleStudy stopped

RESTORE: Phase 3 study stopped before a clear answer

Published by MyelinWatch:

What is being studied

The completed development study tested clemastine for an MS-related eye-movement problem, with the aim of supporting myelin repair.

Research stage

Phase 3 study in people

The study stopped after an early review found it was unlikely to reach its goal

What we know so far

The Phase 3 study stopped after slow enrolment and an interim review indicated it was unlikely to meet its goal. This decision alone does not prove clemastine is ineffective.

What this means for patients today

The study has stopped and is not a participation option. Its early stop is not a definitive answer about clemastine’s effects.

Related dated updates

Myelin repairPhase 1/2 study in people — safety and possible benefitResearch, not an established treatment

ReINFORCE: a planned clemastine study for recent myelin damage

Published by MyelinWatch:

What is being studied

Researchers plan to test clemastine in people with recent areas of myelin loss, using MRI measures to look for possible repair.

Research stage

Phase 1/2 study in people — safety and possible benefit

The study is not yet accepting participants.

What we know so far

The Phase 1/2 study is not yet taking participants according to its current listing. No study results are available.

What this means for patients today

The study is not yet taking participants. Clemastine is not established as a treatment for this purpose.

Myelin repairTesting whether it helps patientsAccepting participants

ReCOVER: studying clemastine after optic neuritis

Published by MyelinWatch:

What is being studied

Researchers are testing clemastine after an acute episode of optic neuritis. Vision-response tests and MRI will look for possible signs of repair.

Research stage

Testing whether it helps patients

The current listing is open to participants.

What we know so far

The Phase 2 study is currently open to participants at UCSF. Its planned tests are not evidence that clemastine improves vision or repairs myelin in patients.

What this means for patients today

This is a study, not an available treatment. The listed centre is in the United States, and participation depends on eligibility.

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

Myelin repairPreparing for a first study in peoplePermission granted; study not started

PTD802: permission granted for a first study in people

Published by MyelinWatch:

What is being studied

PTD802 targets the GPR17 receptor and is being developed as a possible way to guide immature cells toward becoming myelin-making cells.

Research stage

Preparing for a first study in people

The FDA has allowed a first study to proceed; it is not listed as started.

What we know so far

The FDA has permitted a first-in-human study, initially in healthy volunteers. Permission is not evidence that anyone has received the drug or that it works in MS.

What this means for patients today

The study is a permitted next step, not an available treatment. No MS study or patient benefit is established.

Related dated updates

Organisation: Contineum Therapeutics · United States

Myelin repairPhase 2 study in peopleStudy completed

PIPE-307/VISTA: completed Phase 2 study found no expected benefit

Published by MyelinWatch:

What is being studied

The completed VISTA study tested PIPE-307, which blocks the M1 receptor, as a possible way to support myelin repair.

Research stage

Phase 2 study in people

The study's planned measures did not show the hoped-for benefit

What we know so far

The planned measures of benefit did not show the expected effect. Whether PIPE-307 will continue to be developed for MS remains uncertain.

What this means for patients today

The study did not show the hoped-for benefit on its planned measures. PIPE-307 is not an established treatment.

Related dated updates

Organisation: MRC Clinical Trials Unit at UCL · United Kingdom

Myelin repairPhase 3 study evidenceCurrent human-study status unknown

OCTOPUS: testing metformin and alpha-lipoic acid in progressive MS

Published by MyelinWatch:

What is being studied

OCTOPUS tested metformin and alpha-lipoic acid in progressive MS. After an interim review, the alpha-lipoic acid arm continues to Stage 2 and the metformin arm stops.

Research stage

Phase 3 study evidence; current human-study status is unknown

The programme is listed as active; current human-study status is unknown.

What we know so far

The trial team reported an interim MRI and clinical signal for alpha-lipoic acid on 17 September 2026. This supports further testing, not a final result on benefit or safety. The metformin arm did not advance.

What this means for patients today

This is a UK and Australian research study, not an available treatment. UK residents could register interest in Stage 2 at the 17 September announcement; current enrolment and eligibility require direct confirmation. No Greek centre is confirmed. The interim decision does not establish clinical benefit.

Related dated updates

Myelin repairPhase 1 study in peopleStudy completed

Metformin in progressive MS: completed Phase 1, results awaited

Published by MyelinWatch:

What is being studied

The completed early Phase 1 study assessed metformin in people with primary or secondary progressive MS, focusing first on safety.

Research stage

Phase 1 study in people

Completed; results have not yet been published

What we know so far

The study is complete, but public results have not yet been published. Its findings cannot be judged from the information currently available.

What this means for patients today

This small early study did not establish benefit. Metformin is not an approved myelin-repair treatment on this evidence.

Myelin repairTesting whether it helps patientsAccepting participants

Metformin in older adults with MS: a Phase 2 study

Published by MyelinWatch:

What is being studied

Researchers are testing metformin in adults aged 55–75 with MS, measuring safety and changes with brain scans and specialised myelin-related measures.

Research stage

Testing whether it helps patients

The current listing is open to participants.

What we know so far

The Phase 2 study is currently open to participants at a centre in Buffalo, United States. Results are not yet available.

What this means for patients today

The study is not a treatment recommendation. Participation depends on the study’s eligibility rules and site; no Greek site is listed.

Myelin repairTesting whether it helps patientsOngoing, not accepting participants

MACSiMiSE-BRAIN: metformin study in progressive MS

Published by MyelinWatch:

What is being studied

The study is examining whether metformin may affect repair-related processes in people with progressive MS.

Research stage

Testing whether it helps patients

The study continues without taking new participants.

What we know so far

The Phase 2 study is continuing in Belgium but is not accepting new participants. Results have not yet been reported.

What this means for patients today

There is no current route to join this study through its listed centres, and metformin is not established as a myelin-repair treatment.

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

Myelin repairPreparing for a first study in peopleResearch, not an established treatment

Lucid-21-302: a planned Phase 2 test of PAD2 inhibition

Published by MyelinWatch:

What is being studied

Researchers plan to test whether Lucid-21-302, which blocks PAD2, can be studied safely and may help in progressive MS.

Research stage

Preparing for a first study in people

A human study is planned; no current participation route is listed.

What we know so far

The FDA has allowed development to proceed, but no public Phase 2 trial registration or participating site is listed here. No patient benefit is established.

What this means for patients today

This permission step is not evidence that the approach works or a current way to join a trial.

Related dated updates

Organisation: Johannes Gutenberg University Mainz · Germany

Myelin repairNot tested in peopleResearch, not an established treatment

Theophylline skin patch: preparing for a first safety study

Published by MyelinWatch:

What is being studied

The team is refining a low-dose skin patch intended to deliver theophylline and affect HDAC2, a protein linked to myelin repair.

Research stage

Not tested in people

Work remains in the laboratory and product development; a first safety study is planned.

What we know so far

Current work concerns laboratory findings and patch development. A safety study in healthy volunteers is planned but has not been shown to have started.

What this means for patients today

This is early laboratory work, not a treatment for people with MS. A planned volunteer study would first address safety, not benefit in MS.

Related dated updates

Organisation: Monash University · Australia

Myelin repairNo clinical study in MS is establishedResearch, not an established treatment

DITPA: laboratory and animal research into possible myelin repair

Published by MyelinWatch:

What is being studied

NeuOrphan presents Dioprotectome as a candidate for MS that is still at the laboratory-and-animal research stage. The available sources do not establish that Dioprotectome and DITPA are the same molecule. Separately, Monash studies DITPA, a compound related to thyroid hormones, for a possible role in myelin repair.

Research stage

No clinical study in MS is established

Research so far is in laboratory cells or animal models.

What we know so far

The Monash programme listing says this research is active through March 2028. Findings reported for DITPA are from laboratory and animal studies only. No established clinical study of DITPA in MS or proven benefit for people with MS is documented.

What this means for patients today

DITPA is not an available treatment for MS. The available sources do not establish a clinical study of DITPA for MS, so they do not show whether it benefits people with MS.

Related dated updates

Myelin repairNot tested in peopleResearch, not an established treatment

Cambridge: neural stem cells studied in animal models

Published by MyelinWatch:

What is being studied

Researchers are investigating transplantation of neural stem cells created directly from other cells as a possible way to address long-term myelin loss.

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

Early findings suggest the approach may work in animal models of chronic myelin loss. This is not evidence of safety or benefit in people.

What this means for patients today

The cell approach has not been tested in people with MS. Delivery and safety questions remain before a human study could be considered.

Myelin repairNot tested in peopleResearch, not an established treatment

Gene-edited myelin-making cells: tested in rodents

Published by MyelinWatch:

What is being studied

Researchers modified human precursor cells so they can develop into myelin-making cells, then studied how the cells move toward chronic lesions.

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

In rodents, the cells moved toward long-term lesions and increased myelin repair. These animal findings do not establish safety or benefit in people.

What this means for patients today

This cell approach has not been tested in people with MS. Reliable manufacturing and long-term safety checks remain necessary.

Myelin repairNot tested in peopleResearch, not an established treatment

CN045: a molecule being refined before human studies

Published by MyelinWatch:

What is being studied

CN045 is a small molecule intended to help immature cells mature into cells that make myelin. Researchers are refining it before considering human testing.

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

Promising effects have been reported in human cells studied in the laboratory and in mice. These findings do not show safety or benefit in people with MS.

What this means for patients today

CN045 is not a treatment. Further development and safety work are needed before a study in people could be considered.

Related dated updates

Organisation: Cambridge Clinical MS Research Group · United Kingdom

Myelin repairPhase 2 study in peopleStudy completed

CCMR2: a completed Phase 2a study of metformin and clemastine

Published by MyelinWatch:

What is being studied

The completed CCMR2 study combined metformin and clemastine to explore whether they could support myelin repair.

Research stage

Phase 2 study in people

Promising change in the brain's electrical response to vision

What we know so far

The study reported a change in the electrical response to vision, a biological signal. It did not find short-term improvement in disability; a full peer-reviewed paper and confirmation are still needed.

What this means for patients today

The finding is an early signal, not proof of patient benefit or an available treatment. The study is complete.

Related dated updates

Myelin repairNot tested in peopleResearch, not an established treatment

Bavisant: laboratory and animal research into myelin repair

Published by MyelinWatch:

What is being studied

Researchers are studying bavisant, which blocks the histamine H3 receptor, to see whether it can support myelin repair.

Research stage

Not tested in people

Research so far is in laboratory cells or animal models.

What we know so far

Effects have been reported in human cells and animal models. No study in people with MS is registered, so patient benefit is unknown.

What this means for patients today

This is early research, not a treatment people with MS can use. It has not been tested in patients.

Related dated updates

Myelin repairTesting whether it helps patientsAccepting participants

ACT-1004-1239: testing one receptor target in progressive MS

Published by MyelinWatch:

What is being studied

Researchers are testing a drug that blocks the receptor called CXCR7 or ACKR3 in progressive MS. MRI, nerve-response and biochemical measures will look for possible repair signals.

Research stage

Testing whether it helps patients

The current listing is open to participants.

What we know so far

This Phase 2 study was accepting participants in the Netherlands at country level in the official CTIS check on 25 October 2026. Greece was not listed. Its planned measures are not results, and no benefit has been established.

What this means for patients today

It is a study, not an available treatment. Country-level recruitment in the Netherlands does not establish a place at an individual centre; participation depends on the study's criteria.