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: NEW YORK X1 10036
Company CEO: Daniel Vitt
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Albania, Armenia, Bosnia, Bulgaria, Canada, Colombia, Czech Republic, Estonia, Georgia, Germany, Greece, India, Jordan, Lebanon, Lithuania, Mexico, Moldova, Montenegro, Netherlands, North Macedonia, Peru, Poland, Romania, Serbia, Spain, Turkey, Ukraine, United Kingdom, United States
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 results on 2025-09-25 for Vidofludimus
- Clinical Outcomes Reported - Immunic presented P2 Multiple Sclerosis results on 2025-06-24 for Vidofludimus
Highest Development Phases
Phase 3: Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting
Phase 2: Multiple Sclerosis, Chronic Progressive
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
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, Chronic Progressive |
2025-01-07 |
50% |
2024-04-30 |
Primary Completion Date|Primary Endpoints |
2024-514618-11-00 |
P3-IMU-838-RMS-01 | P3 |
Recruiting |
Multiple Sclerosis |
2032-04-30 |
2025-05-02 |
Treatments |
|
NCT03846219 |
EMPhASIS | P2 |
Active, not recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2020-04-24 |
50% |
2025-02-07 |
|
NCT05134441 |
ENSURE-1 | P3 |
Recruiting |
Multiple Sclerosis |
2024-09-01 |
28% |
2025-02-07 |
Primary Endpoints|Treatments |
2024-514619-88-00 |
P3-IMU-838-RMS-02 | P3 |
Recruiting |
Multiple Sclerosis |
2032-10-30 |
2025-05-02 |
Treatments |
|
NCT05201638 |
ENSURE-2 | P3 |
Recruiting |
Multiple Sclerosis, Relapsing-Remitting |
2024-10-01 |
28% |
2025-02-07 |
|
2024-514617-35-00 |
P2-IMU-838-PMS | P2 |
Recruiting |
Multiple Sclerosis |
2032-12-31 |
2025-05-02 |
Treatments |