{"id":"stelara-eu-sourced","safety":{"commonSideEffects":[{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":{"chemblId":"CHEMBL5857501","moleculeType":null,"molecularWeight":"542.39"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Stelara (ustekinumab) binds to the p40 subunit shared by IL-12 and IL-23, preventing these pro-inflammatory cytokines from activating T cells and other immune cells. This dual inhibition reduces the Th1 and Th17 immune responses that drive autoimmune and inflammatory diseases. The mechanism is particularly effective in conditions where these pathways are pathogenic, such as psoriasis, Crohn's disease, and ulcerative colitis.","oneSentence":"Stelara is a human monoclonal antibody that blocks the IL-12 and IL-23 cytokines to suppress immune-mediated inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:36:27.239Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe plaque psoriasis"},{"name":"Active Crohn's disease"},{"name":"Active ulcerative colitis"},{"name":"Psoriatic arthritis"},{"name":"Ankylosing spondylitis"}]},"trialDetails":[{"nctId":"NCT04728360","phase":"PHASE3","title":"Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis","status":"COMPLETED","sponsor":"Bio-Thera Solutions","startDate":"2021-07-06","conditions":"Plaque Psoriasis","enrollment":556},{"nctId":"NCT04772274","phase":"PHASE1","title":"A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects","status":"COMPLETED","sponsor":"Samsung Bioepis Co., Ltd.","startDate":"2021-02-04","conditions":"Healthy","enrollment":201}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Stelara (EU-sourced)","genericName":"Stelara (EU-sourced)","companyName":"Bio-Thera Solutions","companyId":"bio-thera-solutions","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Stelara (EU-sourced) is used to treat moderate to severe plaque psoriasis. It is a treatment option that has been compared to another medication, BAT2206, in clinical trials.","enrichmentLevel":3,"visitCount":2,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}