MyelinWatch EL
← Studies & programmes
Emerging treatmentsLarge study to confirm benefit and safetyOngoing, not accepting participants

Vidofludimus calcium: an experimental oral drug for relapsing and progressive MS

Published by MyelinWatch:

Organisation
Immunic · United States
Study sponsor
Immunic AG
Researcher
Robert J. Fox and colleagues

Vidofludimus calcium (IMU-838) · Vidofludimus calcium (IMU-838) is an experimental oral drug. Immunic says it activates a protein called Nurr1 and blocks an enzyme called DHODH, aiming to combine nerve protection with less inflammation. The Phase 3 ENSURE trials test it in relapsing MS; the Phase 2 CALLIPER trial tested it in progressive MS.

What is being studied

Vidofludimus calcium (IMU-838) is an experimental oral drug. Immunic says it activates a protein called Nurr1 and blocks an enzyme called DHODH, aiming to combine nerve protection with less inflammation. The Phase 3 ENSURE trials test it in relapsing MS; the Phase 2 CALLIPER trial tested it in progressive MS.

Research stage

Large study to confirm benefit and safety

The study continues without taking new participants.

What we know so far

CALLIPER randomised 467 people with progressive MS and did not meet its main goal, percent brain volume change. The share of people with adverse events on the drug was similar to placebo (69.4% versus 68.5%; serious 8.1% versus 6.5%). Immunic reported at MSToronto2026 that favourable disability trends were maintained in the open-label extension, which has no placebo group. Its other disability findings come from after-the-fact analyses with a newly proposed measure.

What this means for patients today

Vidofludimus calcium remains experimental and is not approved anywhere. The progressive MS findings are not proof of benefit. Phase 3 results in relapsing MS have not yet been reported. On 1 October 2026 the official records listed ENSURE-1 and ENSURE-2 as active and not accepting new participants. CALLIPER's record shows an unknown status and was last updated on 29 April 2024.

Next documented step

Immunic expects ENSURE top-line results by the end of 2026 and plans a Phase 3 trial in progressive MS.

Treatment or approach
Oral Nurr1 activator and DHODH inhibitor for relapsing and progressive MS
How it is intended to work
Oral Nurr1 activator and selective DHODH inhibitor, according to Immunic
Where the study is running
ENSURE and CALLIPER registry sites are in several countries; not approved in any jurisdiction
Source: Immunic — official company announcement ↗Source: ClinicalTrials.gov — CALLIPER, NCT05054140 ↗ Source: ClinicalTrials.gov — ENSURE-1, NCT05134441 ↗ Source: ClinicalTrials.gov — ENSURE-2, NCT05201638 ↗
Published by MyelinWatch
Last substantive MyelinWatch update

Programme updates — newest research developments first

  1. Open-label extension and after-the-fact analyses of a Phase 2 study, reported by the sponsorResearch event/source date:

    Vidofludimus calcium: new progressive MS analyses from a Phase 2 study that missed its main goal

    On 21 October 2026, Immunic reported new analyses of CALLIPER, a Phase 2 study that randomised 467 people with primary or secondary progressive multiple sclerosis (MS) to oral vidofludimus calcium or placebo. The study did not meet its main goal, percent brain volume change. In the open-label extension, which 387 people entered, the company says the favourable disability trends seen earlier were maintained among those who continued treatment, without giving figures in its announcement. Through the 27 January 2026 data cutoff, 6.5% had stopped; 44.4% had at least one treatment-emergent adverse event, 5.7% a serious one and 3.1% a liver-related one. An event during treatment does not show that the drug caused it. In an after-the-fact analysis with a newly proposed disability measure, people on the drug were 2.47 times more likely than those on placebo to have 24-week confirmed disability improvement, and 1.5 times more likely to have a better outcome with a second method. Other posters covered an exploratory link between Epstein-Barr virus T-cell signatures and a thinking-speed test, and laboratory and mouse findings.

    Source: Immunic — official company announcement ↗Source: ClinicalTrials.gov — CALLIPER, NCT05054140 ↗ Source: ClinicalTrials.gov — ENSURE-1, NCT05134441 ↗ Source: ClinicalTrials.gov — ENSURE-2, NCT05201638 ↗