{"id":"ct-p43","safety":{"commonSideEffects":[{"rate":null,"effect":"Cardiotoxicity / left ventricular dysfunction"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Diarrhea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CT-P43 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin). It binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells, preventing ligand binding and receptor dimerization, which leads to inhibition of downstream signaling pathways and induction of antibody-dependent cellular cytotoxicity (ADCC). This mechanism is effective in HER2-overexpressing cancers.","oneSentence":"CT-P43 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:45:32.006Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)"}]},"trialDetails":[{"nctId":"NCT06951828","phase":"PHASE1","title":"A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2025-05-30","conditions":"Healthy Male Subjects","enrollment":162},{"nctId":"NCT04673786","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis","status":"COMPLETED","sponsor":"Celltrion","startDate":"2021-01-11","conditions":"Psoriasis","enrollment":509},{"nctId":"NCT04428814","phase":"PHASE1","title":"Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-08-03","conditions":"Healthy Subjects","enrollment":271}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":3,"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-P43","genericName":"CT-P43","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P43 is a biosimilar of trastuzumab that targets HER2-positive cancer cells by binding to the HER2 receptor and blocking growth signaling. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}