{"id":"imu-838-tablets","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Upper respiratory tract infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"IMU-838 is a selective immunomodulator that inhibits dihydroorotate dehydrogenase (DHODH) to reduce proliferation of activated lymphocytes while preserving regulatory T cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:15:49.162Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis"},{"name":"Crohn's disease"},{"name":"Primary biliary cholangitis (PBC)"}]},"trialDetails":[{"nctId":"NCT05134441","phase":"PHASE3","title":"Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Immunic AG","startDate":"2021-11-18","conditions":"Multiple Sclerosis","enrollment":1121},{"nctId":"NCT05201638","phase":"PHASE3","title":"Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Immunic AG","startDate":"2022-01-12","conditions":"Multiple Sclerosis, Relapsing-Remitting","enrollment":1100},{"nctId":"NCT04379271","phase":"PHASE2, PHASE3","title":"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)","status":"COMPLETED","sponsor":"Immunic AG","startDate":"2020-06-11","conditions":"COVID-19","enrollment":234},{"nctId":"NCT05054140","phase":"PHASE2","title":"Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Immunic AG","startDate":"2021-09-30","conditions":"Multiple Sclerosis","enrollment":450},{"nctId":"NCT03846219","phase":"PHASE2","title":"MRI Trial to exPlore the efficAcy and Safety of IMU-838 in Relapsing Remitting Multiple Sclerosis (EMPhASIS)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Immunic AG","startDate":"2019-01-28","conditions":"Relapsing-Remitting Multiple Sclerosis (RRMS)","enrollment":210},{"nctId":"NCT03341962","phase":"PHASE2","title":"Phase 2 Dose-finding IMU-838 for Ulcerative Colitis","status":"TERMINATED","sponsor":"Immunic AG","startDate":"2018-03-15","conditions":"Ulcerative Colitis","enrollment":263}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Vidofludimus calcium","vidofludimus calcium"],"phase":"phase_3","status":"active","brandName":"IMU-838 tablets","genericName":"IMU-838 tablets","companyName":"Immunic AG","companyId":"immunic-ag","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}