{"id":"mirikizumab-iv","safety":{"commonSideEffects":[{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL3990014","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"IL-23 is a key cytokine driving Th17 cell differentiation and intestinal inflammation. By blocking the p19 subunit of IL-23, mirikizumab prevents IL-23-mediated immune activation while preserving IL-12 signaling, which is important for antimicrobial immunity. This selective IL-23 inhibition reduces pathogenic T cell responses in inflammatory bowel disease.","oneSentence":"Mirikizumab is a monoclonal antibody that selectively inhibits IL-23 signaling by binding to the p19 subunit of IL-23, reducing inflammatory responses in the gut.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:34:35.599Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Ulcerative colitis"},{"name":"Crohn's disease"}]},"trialDetails":[{"nctId":"NCT05509777","phase":"PHASE3","title":"A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2024-03-13","conditions":"Crohn's Disease","enrollment":90},{"nctId":"NCT04844606","phase":"PHASE3","title":"A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2021-05-26","conditions":"Ulcerative Colitis, Ulcerative Colitis Chronic, Inflammatory Bowel Diseases","enrollment":150},{"nctId":"NCT06937099","phase":"PHASE3","title":"Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-06-26","conditions":"Crohn's Disease, Obesity or Overweight","enrollment":290},{"nctId":"NCT06937086","phase":"PHASE3","title":"Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-06-26","conditions":"Ulcerative Colitis, Obesity or Overweight","enrollment":350},{"nctId":"NCT07483073","phase":"PHASE2","title":"A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","status":"NOT_YET_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2026-04","conditions":"Colitis, Ulcerative, Crohn Disease","enrollment":60},{"nctId":"NCT07483099","phase":"PHASE2","title":"A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","status":"NOT_YET_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2026-04","conditions":"Crohn Disease","enrollment":60},{"nctId":"NCT05784246","phase":"PHASE3","title":"A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2023-11-22","conditions":"Ulcerative Colitis","enrollment":60},{"nctId":"NCT07186101","phase":"PHASE2","title":"LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:","status":"RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2025-11-11","conditions":"Ulcerative Colitis","enrollment":252},{"nctId":"NCT06864403","phase":"PHASE4","title":"Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2025-08-12","conditions":"Pouchitis, Pouches, Ileoanal, Pouch, Ileal","enrollment":25},{"nctId":"NCT07292012","phase":"PHASE4","title":"Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease","status":"NOT_YET_RECRUITING","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","startDate":"2026-01","conditions":"Crohn Disease (CD)","enrollment":110},{"nctId":"NCT04232553","phase":"PHASE3","title":"A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2020-06-22","conditions":"Crohn's Disease","enrollment":996},{"nctId":"NCT06997965","phase":"PHASE4","title":"Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD","status":"NOT_YET_RECRUITING","sponsor":"Alimentiv Inc.","startDate":"2026-02-01","conditions":"Crohn Disease","enrollment":60},{"nctId":"NCT05767021","phase":"PHASE3","title":"A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Eli Lilly and Company","startDate":"2023-05-17","conditions":"Ulcerative Colitis, Ulcerative Colitis Chronic","enrollment":172},{"nctId":"NCT03524092","phase":"PHASE3","title":"A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-10-19","conditions":"Ulcerative Colitis","enrollment":1177},{"nctId":"NCT07059130","phase":"PHASE4","title":"Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerative Colitis","status":"NOT_YET_RECRUITING","sponsor":"Rubix LS","startDate":"2025-07-16","conditions":"Crohn Disease (CD), Crohns Disease, Ulcerative Colitis (UC)","enrollment":150},{"nctId":"NCT03518086","phase":"PHASE3","title":"An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2018-06-18","conditions":"Ulcerative Colitis","enrollment":1281},{"nctId":"NCT03926130","phase":"PHASE3","title":"A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-07-23","conditions":"Crohn's Disease","enrollment":1158},{"nctId":"NCT01947933","phase":"PHASE1","title":"A Safety Study of Mirikizumab (LY3074828)","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2013-10","conditions":"Psoriasis","enrollment":45},{"nctId":"NCT04004611","phase":"PHASE2","title":"A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2020-05-18","conditions":"Ulcerative Colitis","enrollment":26},{"nctId":"NCT03053622","phase":"PHASE1","title":"A Study of Mirikizumab (LY3074828) Injection in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-04-24","conditions":"Healthy","enrollment":67},{"nctId":"NCT02568423","phase":"PHASE1","title":"A Study of Mirikizumab (LY3074828) in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-12-02","conditions":"Healthy","enrollment":51},{"nctId":"NCT04137380","phase":"PHASE1","title":"A Study of Mirikizumab in Healthy Chinese Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2019-12-04","conditions":"Healthy","enrollment":60},{"nctId":"NCT02891226","phase":"PHASE2","title":"A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2016-12-14","conditions":"Crohn's Disease","enrollment":191},{"nctId":"NCT04469062","phase":"PHASE3","title":"A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis","status":"WITHDRAWN","sponsor":"Eli Lilly and Company","startDate":"2021-04-20","conditions":"Ulcerative Colitis","enrollment":""},{"nctId":"NCT02589665","phase":"PHASE2","title":"A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-12-09","conditions":"Ulcerative Colitis","enrollment":249},{"nctId":"NCT03220126","phase":"PHASE1","title":"A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2017-07-17","conditions":"Healthy","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":8,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["LY3074828"],"phase":"marketed","status":"active","brandName":"Mirikizumab - IV","genericName":"Mirikizumab - IV","companyName":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","companyId":"groupe-d-etude-therapeutique-des-affections-inflammatoires-digestives","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Mirikizumab is a monoclonal antibody that selectively inhibits IL-23 signaling by binding to the p19 subunit of IL-23, reducing inflammatory responses in the gut. Used for Ulcerative colitis, Crohn's disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}