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ASTX727
ASTX727 is a fixed-dose combination of decitabine and cedazuridine that inhibits DNA methyltransferase to reactivate silenced tumor suppressor genes in myelodysplastic syndrome.
ASTX727 is a fixed-dose combination of decitabine and cedazuridine that inhibits DNA methyltransferase to reactivate silenced tumor suppressor genes in myelodysplastic syndrome. Used for Myelodysplastic syndrome (MDS), including MDS with excess blasts.
At a glance
| Generic name | ASTX727 |
|---|---|
| Also known as | Oral decitabine and cedazuridine, INQOVI, C-DEC, Inqovi, decitabine 35 mg + cedazuridine 100 mg |
| Sponsor | Taiho Oncology, Inc. |
| Drug class | Hypomethylating agent |
| Target | DNA methyltransferase (DNMT) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Decitabine is a hypomethylating agent that inhibits DNA methyltransferase, leading to demethylation of DNA and reactivation of aberrantly silenced genes. Cedazuridine is a cytidine deaminase inhibitor that increases decitabine bioavailability by preventing its degradation, allowing for oral administration instead of intravenous infusion. This combination restores normal gene expression patterns in myelodysplastic syndrome cells.
Approved indications
- Myelodysplastic syndrome (MDS), including MDS with excess blasts
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Fatigue
- Thrombocytopenia
- Neutropenia
- Anemia
Key clinical trials
- Venetoclax in Combination With ASTX727 for the Treatment of Chronic Myelomonocytic Leukemia and Other Myelodysplastic Syndrome/Myeloproliferative Neoplasm (PHASE2)
- A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs) (PHASE2)
- Testing the Combination of Targeted Radiotherapy With Anti-Cancer Drugs, Venetoclax and ASTX-727, to Improve Outcomes for Adults With Newly Diagnosed Acute Myeloid Leukemia (PHASE1)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (PHASE1)
- Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma (PHASE2)
- Testing the Combination of Nivolumab and ASTX727 for Relapsed or Refractory B-Cell Lymphoma (PHASE1)
- Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ASTX727 CI brief — competitive landscape report
- ASTX727 updates RSS · CI watch RSS
- Taiho Oncology, Inc. portfolio CI