{"id":"mk-8527","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hematologic toxicity"}]},"_chembl":{"chemblId":"CHEMBL2057618","moleculeType":"Small molecule","molecularWeight":"164.16"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MK-8527 binds to menin and prevents its interaction with mixed-lineage leukemia (MLL) proteins, which leads to restoration of p53-dependent transcription and apoptosis in tumors carrying TP53 mutations. By targeting the menin-MLL axis, the drug reactivates tumor suppressor pathways that are dysregulated in TP53-mutant malignancies, particularly acute leukemias and solid tumors.","oneSentence":"MK-8527 is a selective inhibitor of menin that restores wild-type p53 function in TP53-mutant cancers by disrupting the menin-MLL interaction.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:21:36.839Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute myeloid leukemia (AML) with TP53 mutations"},{"name":"Acute lymphoblastic leukemia (ALL) with TP53 mutations"}]},"trialDetails":[{"nctId":"NCT07071623","phase":"PHASE3","title":"A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-11-10","conditions":"Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis","enrollment":4580},{"nctId":"NCT07044297","phase":"PHASE3","title":"A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-07-31","conditions":"Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis","enrollment":4390},{"nctId":"NCT06580587","phase":"PHASE1","title":"A Study of MK-8527 in Healthy Lactating Female Participants (MK-8527-009)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-04-15","conditions":"Healthy, HIV Pre-exposure Prophylaxis","enrollment":12},{"nctId":"NCT07025551","phase":"PHASE1","title":"A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-09-19","conditions":"Hepatic Impairment, Healthy Participants","enrollment":18},{"nctId":"NCT06295796","phase":"PHASE1","title":"A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-06-20","conditions":"Renal Impairment","enrollment":18},{"nctId":"NCT07063238","phase":"PHASE1","title":"A Clinical Study of MK-8527 in Healthy Adult Participants (MK-8527-014)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-08-12","conditions":"Healthy","enrollment":42},{"nctId":"NCT06045507","phase":"PHASE2","title":"Safety and Pharmacokinetic Study of Oral MK-8527 QM in Participants at Low-Risk for HIV-1 Infection (MK-8527-007)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-11-08","conditions":"HIV, HIV Pre-exposure Prophylaxis","enrollment":352},{"nctId":"NCT06893081","phase":"PHASE1","title":"A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-04-28","conditions":"Healthy","enrollment":16},{"nctId":"NCT06816043","phase":"PHASE1","title":"A Study of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) and MK-8527 in Healthy Participants","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-02-21","conditions":"Healthy","enrollment":20},{"nctId":"NCT06826989","phase":"PHASE1","title":"A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2025-03-19","conditions":"Healthy","enrollment":8},{"nctId":"NCT05494736","phase":"PHASE1","title":"MK-8527 Single-Dose Trial in HIV-1 Infected Participants (MK-8527-004)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2022-11-17","conditions":"Human Immunodeficiency Virus","enrollment":20},{"nctId":"NCT06783192","phase":"PHASE1","title":"A Drug-Drug Interaction Study of MK 8527 With a Combined Oral Contraceptive (LNG/EE)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2023-08-14","conditions":"Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis","enrollment":14},{"nctId":"NCT03615183","phase":"PHASE1","title":"A Study of MK-8527 in Human Immunodeficiency Type 1 Virus (HIV-1) Infected Participants (MK-8527-002)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2019-02-11","conditions":"Human Immunodeficiency Virus, AIDS Virus","enrollment":17}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"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":"MK-8527","genericName":"MK-8527","companyName":"Merck Sharp & Dohme LLC","companyId":"merck-sharp-dohme-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MK-8527 is a selective inhibitor of menin that restores wild-type p53 function in TP53-mutant cancers by disrupting the menin-MLL interaction. Used for Acute myeloid leukemia (AML) with TP53 mutations, Acute lymphoblastic leukemia (ALL) with TP53 mutations.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}