{"id":"bms-986365","safety":{"commonSideEffects":[{"rate":null,"effect":"Differentiation syndrome"},{"rate":null,"effect":"Cytopenias"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug works by blocking the menin-MLL protein-protein interaction, which is critical for the survival of MLL-rearranged leukemias and other hematologic malignancies. By disrupting this interaction, BMS-986365 allows normal differentiation and apoptosis of leukemic cells. This mechanism is particularly relevant in acute leukemias driven by MLL translocations or NPM1 mutations.","oneSentence":"BMS-986365 is a selective inhibitor of menin that disrupts the interaction between menin and mixed-lineage leukemia (MLL) proteins, restoring normal gene expression in leukemic cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:43:34.554Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement"},{"name":"Mixed-lineage leukemia (MLL)-rearranged acute leukemia"}]},"trialDetails":[{"nctId":"NCT07335796","phase":"PHASE2","title":"A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2026-01-09","conditions":"Prostate Cancer","enrollment":30},{"nctId":"NCT06764485","phase":"PHASE3","title":"A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer","status":"RECRUITING","sponsor":"Celgene","startDate":"2025-03-13","conditions":"Metastatic Castration-resistant Prostate Cancer","enrollment":960},{"nctId":"NCT07242781","phase":"PHASE1","title":"A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants","status":"RECRUITING","sponsor":"Celgene","startDate":"2025-12-15","conditions":"Healthy Volunteers","enrollment":42},{"nctId":"NCT04428788","phase":"PHASE1","title":"Study to Evaluate the Safety and Tolerability of CC-94676 in Participants With Metastatic Castration-Resistant Prostate Cancer","status":"COMPLETED","sponsor":"Celgene","startDate":"2020-06-22","conditions":"Prostatic Neoplasms","enrollment":131},{"nctId":"NCT06433505","phase":"PHASE1","title":"A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants","status":"COMPLETED","sponsor":"Celgene","startDate":"2024-05-30","conditions":"Healthy Volunteers","enrollment":24},{"nctId":"NCT06417229","phase":"PHASE1","title":"Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants","status":"COMPLETED","sponsor":"Celgene","startDate":"2024-05-28","conditions":"Healthy Participants","enrollment":102}],"_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":["AR-LDD, CC-94676","CC-94676"],"phase":"phase_3","status":"active","brandName":"BMS-986365","genericName":"BMS-986365","companyName":"Celgene","companyId":"celgene","modality":"Small molecule","firstApprovalDate":"","aiSummary":"BMS-986365 is a selective inhibitor of menin that disrupts the interaction between menin and mixed-lineage leukemia (MLL) proteins, restoring normal gene expression in leukemic cells. Used for Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement, Mixed-lineage leukemia (MLL)-rearranged acute leukemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}