Inqovi (decitabine and cedazuridine)
An approved treatment for Acute Myeloid Leukemia and Myelodysplastic Syndromes.
The same compound appears under different names depending on the context. Here is how to identify Decitabine and cedazuridine wherever you encounter it, plus the key facts at a glance.
- Generic name
- Decitabine and cedazuridine
- Brand name
- Inqovi
- Development code
- ASTX727
- Drug class
- Hypomethylating agent (oral fixed-dose combination)
- Manufacturer
- Taiho Oncology
- How it's taken
- Oral tablet once daily, 5 days of each 28-day cycle
A once-daily tablet taken for 5 days of each 28-day cycle. Approved in 2020 for myelodysplastic syndromes and chronic myelomonocytic leukemia, and on May 13, 2026 in combination with venetoclax for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy, which makes the venetoclax regimen all oral.
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Where Decitabine and cedazuridine fits
Makes the venetoclax plus hypomethylating agent regimen fully oral, in place of 7 days of azacitidine injections or 5 days of decitabine infusions each cycle. It has not been compared head to head with azacitidine plus venetoclax.
How Decitabine and cedazuridine works
Swallowed decitabine is normally destroyed in the gut and liver by an enzyme called cytidine deaminase before it can reach the blood. Cedazuridine blocks that enzyme, so the decitabine in the same tablet is absorbed and reaches levels similar to the IV drug. Decitabine then works as a hypomethylating agent, locking up DNA methyltransferase so silenced genes are expressed again[1].
Mechanism: Oral decitabine protected from breakdown in the gut by cedazuridine, a cytidine deaminase inhibitor
Side effects and safety
- Myelosuppression. Severe and sometimes fatal low blood counts and infections; counts before each cycle, with cycle delays or dose reductions as needed.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 6 months after (women) or 3 months after (men).
- Complete blood counts before starting, before each cycle and as needed
- Pregnancy test before starting
Inqovi has no boxed warning. Its warnings are severe myelosuppression, including fatal infections, with blood counts before each cycle, and harm to an unborn baby[1]. In the MDS trials new or worsening thrombocytopenia occurred in 82% of patients (grade 3 or 4 in 76%) and neutropenia in 73%; the most common side effects were fatigue, constipation, bleeding, muscle pain, mouth sores, joint pain, nausea, shortness of breath, diarrhea, rash, dizziness, febrile neutropenia, swelling, headache, cough, decreased appetite, upper respiratory infection, pneumonia and raised liver enzymes[1].
With venetoclax the combined regimen carries venetoclax's tumor lysis and neutropenia precautions[2].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Decitabine and cedazuridine
One tablet (35 mg decitabine and 100 mg cedazuridine) by mouth once a day on days 1 to 5 of each 28-day cycle, on an empty stomach at least 2 hours before or after food[1]. For AML it is taken with venetoclax, 2 hours before or after the venetoclax dose, with day 1 of both drugs matched each cycle, until the leukemia progresses or side effects become unacceptable; for MDS or CMML it is taken alone for at least 4 cycles[1]. It must not be swapped for IV decitabine within a cycle[1].
Availability and cost
Only available as the brand-name product.
Help paying for Inqovi
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
$0 Co-Pay Program for eligible patients with certain private insurance. Not valid for prescriptions reimbursed under Medicaid, a Medicare drug plan, TRICARE or other federal or state programs.
For: private insurance · source - Free medicine program
Assistance if your insurance does not fully pay for Inqovi; the page describes help for people whose coverage falls short and refers to the full criteria at taihopatientsupport.com.
For: no insurance, underinsured · source - Insurance and case manager help
Insurance checks, specialty pharmacy coordination, support for people with Medicare or other public insurance, and an optional nurse navigator who calls to talk through Inqovi. Enroll by phone at 1-844-TAIHO-4U or by fax with the Patient Enrollment Form.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Phone is 1-844-TAIHO-4U. The Inqovi page lists Blood Cancer United (1-800-955-4572) and AAMDSIF (1-800-747-2820) as advocacy resources.
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Clinical Trials Co-Pay Fund (all blood cancers) fundOpen
Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Patient Aid Program fundOpen
Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.
The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.” - From a charity · HealthWell FoundationMyelodysplastic Syndromes (Medicare Access) fundOpen
Pays for: Copays, premiums or other treatment costs. Medicare patients only.
Clinical trial results
Study ASTX727-07 (NCT04657081), a single-arm study of 101 adults with newly diagnosed AML who were 75 or older or unfit for intensive chemotherapy, gave Inqovi with venetoclax. Complete remission was reached by 41.6% and complete remission with partial count recovery by 52.5%; the median time to complete remission was 2.0 months, and 36.4% (16/44) of transfusion-dependent patients became transfusion independent[1].
The MDS approval rests on 2 crossover studies (ASTX727-01-B and ASCERTAIN) showing that the tablet delivers the same decitabine exposure as the IV drug[1].
Development history
Inqovi was developed by Astex Pharmaceuticals, part of Otsuka, and is marketed in the United States by Taiho Oncology. The FDA approved it for MDS and CMML on July 7, 2020 and added the AML combination with venetoclax on May 13, 2026[3]. Syndax's SAVE study, published in 2026, tested Inqovi with venetoclax and revumenib in relapsed disease (88% overall response in 42 patients), a combination that is investigational[4].
Explore Acute Myeloid Leukemia and Myelodysplastic Syndromes trials
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Common questions about Decitabine and cedazuridine
▸What is Decitabine and cedazuridine (Inqovi)?
A once-daily tablet taken for 5 days of each 28-day cycle. Approved in 2020 for myelodysplastic syndromes and chronic myelomonocytic leukemia, and on May 13, 2026 in combination with venetoclax for newly diagnosed AML in adults 75 or older or unfit for intensive chemotherapy, which makes the venetoclax regimen all oral.
▸How does Decitabine and cedazuridine work?
Swallowed decitabine is normally destroyed in the gut and liver by an enzyme called cytidine deaminase before it can reach the blood. Cedazuridine blocks that enzyme, so the decitabine in the same tablet is absorbed and reaches levels similar to the IV drug. Decitabine then works as a hypomethylating agent, locking up DNA methyltransferase so silenced genes are expressed again[1].
▸What are the side effects of Decitabine and cedazuridine?
Inqovi has no boxed warning. Its warnings are severe myelosuppression, including fatal infections, with blood counts before each cycle, and harm to an unborn baby[1]. In the MDS trials new or worsening thrombocytopenia occurred in 82% of patients (grade 3 or 4 in 76%) and neutropenia in 73%; the most common side effects were fatigue, constipation, bleeding, muscle pain, mouth sores, joint pain, nausea, shortness of breath, diarrhea, rash, dizziness, febrile neutropenia, swelling, headache, cough, decreased appetite, upper respiratory infection, pneumonia and raised liver enzymes[1]. With venetoclax the combined regimen carries venetoclax's tumor lysis and neutropenia precautions[2].
▸How is Decitabine and cedazuridine taken?
One tablet (35 mg decitabine and 100 mg cedazuridine) by mouth once a day on days 1 to 5 of each 28-day cycle, on an empty stomach at least 2 hours before or after food[1]. For AML it is taken with venetoclax, 2 hours before or after the venetoclax dose, with day 1 of both drugs matched each cycle, until the leukemia progresses or side effects become unacceptable; for MDS or CMML it is taken alone for at least 4 cycles[1]. It must not be swapped for IV decitabine within a cycle[1].
▸Is Decitabine and cedazuridine FDA approved?
Yes, Decitabine and cedazuridine (Inqovi) is FDA approved (2020) for the treatment of Acute Myeloid Leukemia and Myelodysplastic Syndromes.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Taiho Pharmaceutical via openFDA · 2026-05-25. Inqovi (decitabine and cedazuridine) tablets prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%2291a0f80b-f865-4d06-a40d-4d148d99ee71%22
- AbbVie Inc. via openFDA · 2026-05-20. Venclexta (venetoclax tablets) prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22b118a40d-6b56-cee3-10f6-ded821a97018%22
- FDA. Inqovi approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212576
- Syndax Pharmaceuticals · 2026-06-11. Syndax Announces Publication of SAVE Data on Revuforj (revumenib) in Combination with Decitabine/Cedazuridine and Venetoclax in Relapsed/Refractory NPM1m, KMT2Ar, and NUP98r AML in the Journal of Clinical Oncology. https://ir.syndax.com/press-releases
- Taiho Oncology. Support and resources. https://www.inqovi.com/support-resources