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Placebo matching IMU-838 tablets
IMU-838 is a selective immunomodulator that inhibits intracellular signaling pathways to reduce pathogenic immune responses.
IMU-838 is a selective immunomodulator that inhibits intracellular signaling pathways to reduce pathogenic immune responses. Used for Ulcerative colitis, Crohn's disease, Relapsing-remitting multiple sclerosis.
At a glance
| Generic name | Placebo matching IMU-838 tablets |
|---|---|
| Also known as | Placebo matching vidofludimus calcium |
| Sponsor | Immunic AG |
| Drug class | Selective immunomodulator |
| Target | Intracellular signaling (TYK2 and related kinases) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
IMU-838 acts as a selective modulator of intracellular signaling, particularly targeting pathways involved in immune cell activation and differentiation. By modulating these pathways, it reduces the production of pro-inflammatory cytokines and shifts immune responses away from pathogenic Th17 and toward regulatory T cell differentiation, thereby suppressing aberrant immune activation in autoimmune and inflammatory conditions.
Approved indications
- Ulcerative colitis
- Crohn's disease
- Relapsing-remitting multiple sclerosis
Common side effects
- Upper respiratory tract infection
- Headache
- Diarrhea
- Nausea
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)
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:
- Placebo matching IMU-838 tablets CI brief — competitive landscape report
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- Immunic AG portfolio CI