Decitabine + cedazuridine (oral)
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.
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.
1.Cedazuridine blocks cytidine deaminase in the gut and liver
- 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: www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-oral-combination-decitabine-and-cedazuridine-tablets-venetoclax-newly-diagnosed-acute. Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Inqovi is oral decitabine; Medicare contractors generally treat it as Part D rather than under the oral anticancer Part B benefit because cedazuridine has no injectable equivalent.
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
- Assistance programmes
- Taiho Oncology Patient Support
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Notes
- EU-licensed 2023 for AML; UK licence and NICE position not yet researched.
Sources: NICE search: decitabine-cedazuridine. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 7 Jul 2020ApprovalUS
MDS/CMML
- 13 May 2026ApprovalUS
With venetoclax in newly diagnosed unfit AML source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | MDS and CMML |
| US | 2026 | Newly diagnosed AML, unfit for intensive induction, with venetoclax (ASCERTAIN-V) |
| Adverse event |
|---|
| Neutropenia and febrile neutropenia Class effect with venetoclax; counts monitored each cycle |
| Nausea, fatigue Common, mostly grade 1-2 |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Trials
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Decitabine + cedazuridine" OR ABSTRACT:"Decitabine + cedazuridine" OR TITLE:"oral" OR ABSTRACT:"oral" OR TITLE:"Inqovi" OR ABSTRACT:"Inqovi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Decitabine + cedazuridine (oral), not a curated reading list.