{"entity":{"id":"decitabine","kind":"drug","name":"Decitabine","aka":["5-aza-2'-deoxycytidine"],"tldr":"Decitabine (Dacogen) is an infusion that loosens the chemical silencing of genes in myelodysplastic syndromes and acute myeloid leukaemia, helping the bone marrow work again. An oral version combined with cedazuridine has its own record.","summary":"Decitabine was approved by the FDA in 2006 for myelodysplastic syndromes of all FAB subtypes and IPSS intermediate-1, intermediate-2 and high-risk groups, on a randomised trial of 170 patients in which decitabine plus supportive care produced responses and delayed progression to AML compared with supportive care alone. The EU authorised Dacogen in 2012 for newly diagnosed AML in adults aged 65 and over not eligible for standard induction (DACO-016). It is the hypomethylating partner for venetoclax in unfit AML alongside azacitidine, and the oral fixed-dose combination decitabine-cedazuridine (Inqovi, 2020) delivers equivalent exposure. Myelosuppression is universal early in treatment and responses typically take four to six cycles.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Decitabine","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=decitabine"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/decitabine"},{"label":"EPAR","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/dacogen"}],"tags":["nci-list"],"related":["decitabine-cedazuridine","azacitidine"],"cancers":["mds","aml","mds-higher-risk"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":[],"companies":["otsuka"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05883956","nct04229979","nct02781883"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Dacogen","modality":"Hypomethylating agent (DNA methyltransferase inhibitor)","mechanism":"Incorporated into DNA after phosphorylation and traps DNA methyltransferase, causing genome-wide hypomethylation that re-expresses silenced genes and drives differentiation or apoptosis.","approvals":[{"region":"US","year":2006,"indication":"Myelodysplastic syndromes, all FAB subtypes and IPSS intermediate-1 to high risk"},{"region":"EU","year":2012,"indication":"Newly diagnosed de novo or secondary AML in adults 65 and over not candidates for standard induction"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/decitabine/","neighbours":{"drug":[{"id":"azacitidine","kind":"drug","name":"Azacitidine","route":"/drugs/azacitidine/"},{"id":"decitabine-cedazuridine","kind":"drug","name":"Decitabine + cedazuridine (oral)","route":"/drugs/decitabine-cedazuridine/"}],"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"mds-higher-risk","kind":"cancer","name":"Higher-risk myelodysplastic syndromes","route":"/cancers/mds-higher-risk/"},{"id":"mds","kind":"cancer","name":"Myelodysplastic syndromes / neoplasms (MDS)","route":"/cancers/mds/"},{"id":"aml-secondary","kind":"cancer","name":"Secondary and therapy-related acute myeloid leukaemia","route":"/cancers/aml-secondary/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"company":[{"id":"otsuka","kind":"company","name":"Otsuka Pharmaceutical","route":"/companies/otsuka/"}],"trial":[{"id":"nct05883956","kind":"trial","name":"A Study Comparing Treatment Preference Between Oral Decitabine/Cedazuridine and Azacitidine in Myelodysplastic Syndrome, Low-Blast Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia","route":"/trials/nct05883956/"},{"id":"nct02781883","kind":"trial","name":"Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML","route":"/trials/nct02781883/"},{"id":"nct07007767","kind":"trial","name":"Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies）","route":"/trials/nct07007767/"},{"id":"nct04229979","kind":"trial","name":"Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2","route":"/trials/nct04229979/"},{"id":"nct06454448","kind":"trial","name":"Phase Ib/II Clinical Study of Adebrelimab in Combination With Decitabine, Albumin-bound Paclitaxel, and Gemcitabine for the First-line Treatment of Metastatic P","route":"/trials/nct06454448/"},{"id":"nct05201066","kind":"trial","name":"Roll-over Study for Patients Who Have Completed a Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Sabatolimab.","route":"/trials/nct05201066/"}],"target":[{"id":"dnmt3a","kind":"target","name":"DNA methyltransferase 3A (DNMT3A)","route":"/targets/dnmt3a/"},{"id":"dnmt1","kind":"target","name":"DNMT1 (DNA methyltransferase 1)","route":"/targets/dnmt1/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}],"pathway":[{"id":"micrornas-in-cancer","kind":"pathway","name":"MicroRNAs in cancer","route":"/pathways/micrornas-in-cancer/"}]}}