{"id":"ct-p44-daratumumab","safety":{"commonSideEffects":[{"rate":"50-80","effect":"Infusion-related reactions"},{"rate":"30-50","effect":"Neutropenia"},{"rate":"20-40","effect":"Anemia"},{"rate":"15-30","effect":"Thrombocytopenia"},{"rate":"20-35","effect":"Fatigue"},{"rate":"15-25","effect":"Upper respiratory tract infection"}]},"_chembl":{"chemblId":"CHEMBL1743007","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a CD38-targeting monoclonal antibody, CT-P44 (daratumumab biosimilar) engages the immune system to eliminate CD38-expressing plasma cells in multiple myeloma. It works through multiple mechanisms including antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC), as well as direct induction of apoptosis in myeloma cells.","oneSentence":"CT-P44 is a monoclonal antibody that binds to CD38 on multiple myeloma cells, triggering their destruction through antibody-dependent cellular cytotoxicity and direct apoptosis.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:08:03.864Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple myeloma (in combination with standard therapies)"},{"name":"Relapsed or refractory multiple myeloma"}]},"trialDetails":[{"nctId":"NCT06952478","phase":"PHASE3","title":"A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma","status":"RECRUITING","sponsor":"Celltrion","startDate":"2025-08-12","conditions":"Refractory or Relapsed Multiple Myeloma","enrollment":486}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2407,"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-P44(Daratumumab)","genericName":"CT-P44(Daratumumab)","companyName":"Celltrion","companyId":"celltrion","modality":"Biologic","firstApprovalDate":"","aiSummary":"CT-P44 (Daratumumab) is an antibody that inhibits the lymphocyte differentiation antigen CD38, which is involved in the ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 enzyme. It is being studied in combination with lenalidomide and dexamethasone for the treatment of refractory or relapsed multiple myeloma.","enrichmentLevel":3,"visitCount":5,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}