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
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 |