{"id":"bcd-089","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Immune-related adverse events (pneumonitis, hepatitis, colitis)"}]},"_chembl":{"chemblId":"CHEMBL4650406","moleculeType":"Antibody"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"BCD-089 is a fully human monoclonal antibody targeting programmed death ligand 1 (PD-L1). By blocking PD-L1, the drug prevents the suppression of T-cell mediated immunity that tumors exploit, thereby reinvigorating the body's immune system to recognize and attack cancer cells. This mechanism is similar to other checkpoint inhibitors in the immuno-oncology space.","oneSentence":"BCD-089 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:08.243Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer"},{"name":"Other solid tumors (under investigation)"}]},"trialDetails":[{"nctId":"NCT04227366","phase":"PHASE3","title":"Study of the Efficacy and Safety of BCD-089 in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Biocad","startDate":"2019-11-19","conditions":"Rheumatoid Arthritis","enrollment":154},{"nctId":"NCT04397562","phase":"PHASE3","title":"A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19","status":"COMPLETED","sponsor":"Biocad","startDate":"2020-04-29","conditions":"COVID-19","enrollment":206},{"nctId":"NCT03455842","phase":"PHASE2","title":"The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis","status":"COMPLETED","sponsor":"Biocad","startDate":"2018-02-01","conditions":"Seropositive RA","enrollment":105},{"nctId":"NCT03103438","phase":"PHASE1","title":"First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects","status":"COMPLETED","sponsor":"Biocad","startDate":"2016-11","conditions":"Healthy","enrollment":19}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["human monoclonal antibody to interleukin-6 receptor"],"phase":"phase_3","status":"active","brandName":"BCD-089","genericName":"BCD-089","companyName":"Biocad","companyId":"biocad","modality":"Biologic","firstApprovalDate":"","aiSummary":"BCD-089 is a monoclonal antibody that binds to and inhibits PD-L1, blocking its interaction with PD-1 and restoring anti-tumor immune responses. Used for Non-small cell lung cancer, Other solid tumors (under investigation).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}