{"entity":{"id":"decitabine-cedazuridine","kind":"drug","name":"Decitabine + cedazuridine (oral)","aka":["Decitabine-cedazuridine","Oral decitabine","Cedazuridine"],"tldr":"Oral decitabine-cedazuridine is a pill version of the hypomethylating chemotherapy that, since May 2026, lets older AML patients take their whole venetoclax regimen at home.","summary":"Cedazuridine inhibits cytidine deaminase in the gut and liver so oral decitabine achieves IV-equivalent exposure. Approved for MDS/CMML (2020). On 13 May 2026 the FDA approved Inqovi with venetoclax for newly diagnosed AML in adults ≥75 or with comorbidities precluding intensive induction, based on ASCERTAIN-V (CR 41.6%, median time to CR 2 months), the first all-oral hypomethylating regimen for AML.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Decitabine/cedazuridine","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Decitabine"}],"tags":[],"related":[],"cancers":["aml","mds-higher-risk"],"sections":[],"technologies":["epigenetic-drugs"],"targets":[],"drugs":["venetoclax"],"companies":["taiho-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":["ascertain-v"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Inqovi","modality":"Oral hypomethylating agent","mechanism":"Decitabine incorporates into DNA and traps DNMT1; cedazuridine protects it from first-pass deamination.","approvals":[{"region":"US","year":2020,"indication":"MDS and CMML"},{"region":"US","year":2026,"indication":"Newly diagnosed AML, unfit for intensive induction, with venetoclax (ASCERTAIN-V)"},{"region":"EU","year":2023,"indication":"EU brand Inaqovi"}],"mechanismSteps":["Cedazuridine blocks cytidine deaminase in the gut and liver","Oral decitabine survives first pass and reaches the marrow","Decitabine is incorporated into DNA and traps DNMT1","Methylation is lost at silenced genes; blasts differentiate or die","Venetoclax removes BCL-2 protection so primed blasts undergo apoptosis"],"dosing":{"route":"Oral","schedule":"One tablet (35 mg decitabine / 100 mg cedazuridine) daily on days 1-5 of each 28-day cycle, with venetoclax 400 mg daily after ramp-up","monitoring":"Blood counts; TLS precautions during venetoclax ramp","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute"},"toxicity":[{"event":"Neutropenia and febrile neutropenia","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Inqovi","note":"Class effect with venetoclax; counts monitored each cycle"},{"event":"Nausea, fatigue","note":"Common, mostly grade 1-2"}],"access":[],"regulatoryEvents":[{"date":"2020-07-07","type":"approval","region":"US","note":"MDS/CMML"},{"date":"2026-05-13","type":"approval","region":"US","note":"With venetoclax in newly diagnosed unfit AML","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute"}]},"route":"/drugs/decitabine-cedazuridine/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"cmml","kind":"cancer","name":"Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms","route":"/cancers/cmml/"},{"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/"}],"technology":[{"id":"epigenetic-drugs","kind":"technology","name":"Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)","route":"/technologies/epigenetic-drugs/"}],"drug":[{"id":"decitabine","kind":"drug","name":"Decitabine","route":"/drugs/decitabine/"},{"id":"venetoclax","kind":"drug","name":"Venetoclax","route":"/drugs/venetoclax/"}],"company":[{"id":"taiho-oncology","kind":"company","name":"Taiho Oncology (Otsuka)","route":"/companies/taiho-oncology/"}],"trial":[{"id":"ascertain-v","kind":"trial","name":"ASCERTAIN-V","route":"/trials/ascertain-v/"}],"pairing":[{"id":"venetoclax-plus-hma","kind":"pairing","name":"Venetoclax + hypomethylating agent","route":"/pairings/venetoclax-plus-hma/"}],"idea":[{"id":"idea-shortened-venetoclax","kind":"idea","name":"Shorter venetoclax courses in unfit AML","route":"/ideas/idea-shortened-venetoclax/"},{"id":"idea-bio2-epigenetic-priming-cold-tumours","kind":"idea","name":"Unmask hidden antigens with a short epigenetic course before immunotherapy","route":"/ideas/idea-bio2-epigenetic-priming-cold-tumours/"}],"roadmap":[{"id":"epigenetics-roadmap","kind":"roadmap","name":"Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome","route":"/roadmaps/epigenetics-roadmap/"}],"term":[{"id":"epigenetic-progenitor-theory","kind":"term","name":"Epigenetic progenitor theory: cancer without a first mutation","route":"/terms/epigenetic-progenitor-theory/"}]}}