Ozmosi | Vidofludimus Drug Profile
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Vidofludimus

Pronounced as: Vye-doe-FLOO-di-mus

Alternative Names: vidofludimus, imu-838, imu838, imu 838, im-90838, im90838, im 90838, vidofludimus calcium, 4SC-101, SC12267
Clinical Status: Active
Latest Update: 2026-03-10
Latest Update Note: News Article

Product Description

Vidofludimus calcium (IMU-838) is a small molecule investigational drug in development as an oral next generation treatment option for patients with multiple sclerosis, or MS, and other chronic inflammatory and autoimmune diseases. (Sourced from: https://imux.com/pipeline/imu-838/)

Mechanisms of Action: DHODH Inhibitor, IL17 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Immunic
Company Location: Eastern America
Company Founding Year: 2016
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Vidofludimus

Countries in Clinic: Albania, Algeria, Armenia, Bosnia, Bulgaria, Canada, Czech Republic, Estonia, Georgia, Germany, India, Jordan, Lebanon, Lithuania, Mexico, Moldova, Montenegro, Netherlands, North Macedonia, Peru, Poland, Romania, Serbia, Ukraine, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 8

Recent & Upcoming Milestones

  • Clinical Outcomes Expected - Immunic announced they will present P3 Multiple Sclerosis results in YE26 for Vidofludimus
  • Clinical Outcomes Reported - Immunic presented P2 Multiple Sclerosis, Progressive results on 2026-02-05 for Vidofludimus
  • Clinical Outcomes Reported - Immunic presented P2 Multiple Sclerosis results on 2025-09-25 for Vidofludimus

Highest Development Phases

Phase 3: Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting

Phase 2: Multiple Sclerosis, Progressive

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2024-514617-35-00

P2-IMU-838-PMS

P2

Recruiting

Multiple Sclerosis, Progressive

2032-12-31

2025-05-02

Treatments

NCT05134441

ENSURE-1

P3

Active, not recruiting

Multiple Sclerosis

2026-11-01

35%

2026-02-24

Primary Endpoints

NCT05201638

ENSURE-2

P3

Active, not recruiting

Multiple Sclerosis, Relapsing-Remitting

2026-11-01

35%

2026-02-24

Primary Completion Date|Primary Endpoints|Study Completion Date

NCT03846219

EMPhASIS

P2

Active, not recruiting

Multiple Sclerosis, Relapsing-Remitting

2020-04-24

50%

2025-02-07

2024-514619-88-00

P3-IMU-838-RMS-02

P3

Recruiting

Multiple Sclerosis

2032-10-30

2025-05-02

Treatments

2024-514618-11-00

P3-IMU-838-RMS-01

P3

Recruiting

Multiple Sclerosis

2032-04-30

2025-05-02

Treatments

2024-516739-29-00

P2-IMU-838-MS

P2

Recruiting

Multiple Sclerosis, Relapsing-Remitting

2029-12-31

2025-05-02

Treatments

NCT05054140

CALLIPER

P2

Active, not recruiting

Multiple Sclerosis, Progressive

2025-01-07

50%

2024-04-30

Primary Completion Date|Primary Endpoints