{"id":"ct-p39","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Decreased appetite"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"},{"rate":null,"effect":"Infusion-related reactions"}]},"_chembl":{"chemblId":"CHEMBL6017522","moleculeType":null,"molecularWeight":"412.54"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"CT-P39 is a biosimilar candidate to atezolizumab, designed to block the PD-L1/PD-1 immune checkpoint pathway. By preventing PD-L1 from engaging PD-1 on T cells, the drug removes a key tumor-mediated immune suppression mechanism, allowing cytotoxic T lymphocytes to recognize and attack cancer cells. This mechanism is used across multiple solid and hematologic malignancies.","oneSentence":"CT-P39 is a monoclonal antibody that binds to and inhibits programmed death ligand 1 (PD-L1), blocking its interaction with PD-1 and restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:08:00.252Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer (NSCLC)"},{"name":"Small cell lung cancer (SCLC)"},{"name":"Urothelial carcinoma"},{"name":"Triple-negative breast cancer (TNBC)"}]},"trialDetails":[{"nctId":"NCT04426890","phase":"PHASE3","title":"To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-12-09","conditions":"Chronic Spontaneous Urticaria","enrollment":634},{"nctId":"NCT04018313","phase":"PHASE1","title":"To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects","status":"COMPLETED","sponsor":"Celltrion","startDate":"2020-05-28","conditions":"Healthy","enrollment":176}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Omalizumab"],"phase":"phase_3","status":"active","brandName":"CT-P39","genericName":"CT-P39","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P39 is a monoclonal antibody that binds to and inhibits programmed death ligand 1 (PD-L1), blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), Urothelial carcinoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}