{"id":"ct-p13-sc-auto-injector","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Infections (including serious infections)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Upper respiratory tract infections"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CT-P13 is a biosimilar of infliximab that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. By blocking TNF-alpha, it suppresses the inflammatory cascade involved in autoimmune and inflammatory diseases. The subcutaneous auto-injector formulation provides a convenient self-administration route compared to intravenous infusion.","oneSentence":"CT-P13 SC is a subcutaneous auto-injector formulation of infliximab, a TNF-alpha inhibitor that blocks tumor necrosis factor signaling to reduce inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:08:07.439Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Rheumatoid arthritis"},{"name":"Ankylosing spondylitis"},{"name":"Psoriatic arthritis"},{"name":"Crohn's disease"},{"name":"Ulcerative colitis"},{"name":"Psoriasis"}]},"trialDetails":[{"nctId":"NCT06738719","phase":"PHASE3","title":"A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Celltrion","startDate":"2025-01-03","conditions":"Moderately to Severely Active Rheumatoid Arthritis","enrollment":192},{"nctId":"NCT03446976","phase":"PHASE1","title":"CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2018-02-21","conditions":"Health, Subjective","enrollment":218}],"_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":[],"phase":"phase_3","status":"active","brandName":"CT-P13 SC Auto-injector","genericName":"CT-P13 SC Auto-injector","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P13 SC is a subcutaneous auto-injector formulation of infliximab, a TNF-alpha inhibitor that blocks tumor necrosis factor signaling to reduce inflammation. Used for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}