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CEDAZURIDINE
Decitabine inhibits DNA methyltransferase, leading to DNA hypomethylation and cellular differentiation or apoptosis.
CEDAZURIDINE is a marketed drug indicated for Myelodysplastic Syndromes (MDS), leveraging decitabine's mechanism of inhibiting DNA methyltransferase to induce DNA hypomethylation and cellular differentiation or apoptosis. The drug's key strength lies in its unique mechanism of action, which differentiates it from other treatments in the MDS market. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | CEDAZURIDINE |
|---|---|
| Drug class | Nucleoside Metabolic Inhibitor [EPC] |
| Target | DNA methyltransferase |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Decitabine works by being incorporated into DNA and inhibiting DNA methyltransferase, which reduces DNA methylation. This can restore normal gene function and lead to cell differentiation or death, particularly in rapidly dividing cancer cells.
Approved indications
- Myelodysplastic Syndromes (MDS)
Common side effects
- fatigue
- hemorrhage
- edema
Drug interactions
- Drugs Metabolized by Cytidine Deaminase
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |