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IMU-838 tablets
IMU-838 is a selective immunomodulator that inhibits dihydroorotate dehydrogenase (DHODH) to reduce proliferation of activated lymphocytes while preserving regulatory T cells.
IMU-838 is a selective immunomodulator that inhibits dihydroorotate dehydrogenase (DHODH) to reduce proliferation of activated lymphocytes while preserving regulatory T cells. Used for Ulcerative colitis, Crohn's disease, Primary biliary cholangitis (PBC).
At a glance
| Generic name | IMU-838 tablets |
|---|---|
| Also known as | Vidofludimus calcium, vidofludimus calcium |
| Sponsor | Immunic AG |
| Drug class | DHODH inhibitor |
| Target | Dihydroorotate dehydrogenase (DHODH) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By selectively inhibiting DHODH, an enzyme critical for pyrimidine synthesis in rapidly dividing immune cells, IMU-838 preferentially suppresses pathogenic T and B cell expansion while sparing regulatory T cells due to their alternative metabolic pathways. This mechanism aims to restore immune tolerance and reduce inflammatory responses in autoimmune diseases. The selective action on activated lymphocytes while preserving immune regulation distinguishes it from broader immunosuppressants.
Approved indications
- Ulcerative colitis
- Crohn's disease
- Primary biliary cholangitis (PBC)
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Headache
- Upper respiratory tract infection
Key clinical trials
- Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (PHASE3)
- Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis (PHASE3)
- A Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 as Addition to Investigator's Choice of Standard of Care Therapy, in Patients With Coronavirus Disease 19 (COVID-19) (PHASE2, PHASE3)
- Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis (PHASE2)
- MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS) (PHASE2)
- Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IMU-838 tablets CI brief — competitive landscape report
- IMU-838 tablets updates RSS · CI watch RSS
- Immunic AG portfolio CI