{"id":"ct-p41","safety":{"commonSideEffects":[{"rate":null,"effect":"Cardiotoxicity/left ventricular dysfunction"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL5941764","moleculeType":null,"molecularWeight":"452.92"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CT-P41 is a monoclonal antibody designed as a biosimilar to trastuzumab (Herceptin), which binds to the human epidermal growth factor receptor 2 (HER2) on cancer cells. This binding blocks HER2-mediated signaling pathways and triggers antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), leading to cancer cell death. As a biosimilar, CT-P41 is intended to have comparable efficacy and safety to the reference trastuzumab product.","oneSentence":"CT-P41 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":"2026-03-28T01:08:00.125Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)"},{"name":"HER2-positive gastric cancer"}]},"trialDetails":[{"nctId":"NCT04757376","phase":"PHASE3","title":"A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis","status":"COMPLETED","sponsor":"Celltrion","startDate":"2021-06-17","conditions":"Postmenopausal Women With Osteoporosis","enrollment":479},{"nctId":"NCT06037395","phase":"PHASE1","title":"Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2021-10-06","conditions":"Healthy Subject","enrollment":154},{"nctId":"NCT04512872","phase":"PHASE1","title":"A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-10-20","conditions":"Healthy Male Subjects","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"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-P41","genericName":"CT-P41","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P41 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), HER2-positive gastric cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}