{"id":"astx727-dose-confirmation","_chembl":null,"modality":"Small molecule","_dailymed":null,"mechanism":{"target":"DNA methyltransferase (DNMT)","explanation":"Decitabine inhibits DNA methyltransferases, leading to hypomethylation and reactivation of tumor suppressor genes. Cedazuridine inhibits cytidine deaminase in the gastrointestinal tract and liver, preventing decitabine degradation and allowing effective oral dosing instead of intravenous administration.","oneSentence":"Combines decitabine (DNA hypomethylating agent) with cedazuridine (cytidine deaminase inhibitor) to enable oral administration and improve bioavailability."},"_scrapedAt":"2026-03-28T05:38:38.087Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779123642,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"azacitidine","brand":"Vidaza","company":"Celgene/Bristol Myers Squibb","rationale":"Injectable hypomethylating agent for MDS and AML"},{"name":"decitabine","brand":"Dacogen","company":"Janssen","rationale":"Injectable DNA methyltransferase inhibitor for MDS"},{"name":"oral azacitidine","brand":"Onureg","company":"Celgene/Bristol Myers Squibb","rationale":"Oral hypomethylating agent for AML maintenance"}],"description":"ASTX727 is an investigational oral combination therapy developed by Astex Pharmaceuticals combining decitabine, a DNA methyltransferase inhibitor, with cedazuridine, a cytidine deaminase inhibitor. The dose confirmation study evaluates optimal dosing in patients with hematologic malignancies.","indications":{"approved":[{"status":"investigational","condition":"Myelodysplastic syndromes (MDS)","patientPopulation":"Adult patients"},{"status":"investigational","condition":"Chronic myelomonocytic leukemia (CMML)","patientPopulation":"Adult patients"},{"status":"investigational","condition":"Acute myeloid leukemia (AML)","patientPopulation":"Adult patients"}]},"trialDetails":[{"nctId":"NCT02103478","phase":"PHASE1, PHASE2","title":"Pharmacokinetic Guided Dose Escalation and Dose Confirmation With Oral Decitabine and Oral Cytidine Deaminase Inhibitor (CDAi) in Patients With Myelodysplastic Syndromes (MDS)","status":"COMPLETED","sponsor":"Astex Pharmaceuticals, Inc.","startDate":"2014-10-28","conditions":"Myelodysplastic Syndrome, MDS","enrollment":130},{"nctId":"NCT05456269","phase":"PHASE1","title":"A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS","status":"WITHDRAWN","sponsor":"Race Oncology Ltd","startDate":"2022-07-29","conditions":"Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ASTX727 oral (combination of oral E7727 and oral decitabine)","IV decitabine"],"phase":"phase_1","status":"active","brandName":"ASTX727 Dose Confirmation","genericName":"ASTX727 Dose Confirmation","companyName":"Astex Pharmaceuticals, Inc.","companyId":"astex-pharmaceuticals-inc","firstApprovalDate":"","aiSummary":"ASTX727, a small molecule, is being studied in combination with Cytarabine Hydrochloride for the treatment of Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Higher Risk Myelodysplastic Syndrome, and Chronic Myelomonocytic Leukemia. ASTX727, also known as Bisantrene Dihydrochloride, is administered in high and low doses as part of the study.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}