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Dacogen (decitabine) only
Decitabine is a DNA methyltransferase inhibitor that reduces DNA methylation, reactivating silenced tumor suppressor genes and promoting differentiation and apoptosis in myelodysplastic cells.
Decitabine is a DNA methyltransferase inhibitor that reduces DNA methylation, reactivating silenced tumor suppressor genes and promoting differentiation and apoptosis in myelodysplastic cells. Used for Myelodysplastic syndromes (MDS), including previously treated and untreated patients, Acute myeloid leukemia (AML) in elderly patients ineligible for intensive chemotherapy.
At a glance
| Generic name | Dacogen (decitabine) only |
|---|---|
| Also known as | decitabine |
| Sponsor | Eisai Inc. |
| Drug class | DNA methyltransferase inhibitor |
| Target | DNA methyltransferase (DNMT) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Decitabine is a cytidine analog that inhibits DNA methyltransferase (DNMT), leading to hypomethylation of DNA. In myelodysplastic syndromes and certain leukemias, aberrant DNA methylation silences tumor suppressor genes; decitabine reverses this epigenetic silencing, allowing re-expression of growth-inhibitory genes and promoting cell differentiation and death. This mechanism is distinct from traditional chemotherapy and works through epigenetic modulation rather than direct cytotoxicity.
Approved indications
- Myelodysplastic syndromes (MDS), including previously treated and untreated patients
- Acute myeloid leukemia (AML) in elderly patients ineligible for intensive chemotherapy
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Fatigue
- Constipation
- Fever
- Infection
Key clinical trials
- Testing the Use of an IDH1 Inhibitor, Olutasidenib, in Acute Myeloid Leukemia Added to ASTX727 and Venetoclax; in High-Risk MDS Added to ASTX727; and Alone in Low Risk MDS (A MyeloMATCH Treatment Substudy) (PHASE2)
- Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial (PHASE4)
- Maintenance Therapy of Hypomethylating Agent (HMA) in Favorable Risk Acute Myeloid Leukemia (AML) Patients (PHASE2)
- IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. (PHASE3)
- Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia (PHASE2)
- Discontinuation of Hypomethylating Agent and Venetoclax in Patients With AML MRD (PHASE2)
- A Phase I/II Trial to Assess the Efficacy and Toxicity of ASTX727 (Oral Decitabine/Cedazuridine) for the Treatment of Hematological Neoplasms After Allogeneic Stem Cell Transplantation (PHASE2)
- A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL) (PHASE1)
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:
- Dacogen (decitabine) only CI brief — competitive landscape report
- Dacogen (decitabine) only updates RSS · CI watch RSS
- Eisai Inc. portfolio CI