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Azacitidine Injection
Azacitidine is a DNA methyltransferase inhibitor that causes hypomethylation of DNA and promotes differentiation and apoptosis of abnormal hematopoietic cells.
Azacitidine is a DNA methyltransferase inhibitor that causes hypomethylation of DNA and promotes differentiation and apoptosis of abnormal hematopoietic cells. Used for Myelodysplastic syndromes (MDS), Chronic myelomonocytic leukemia (CMML), Acute myeloid leukemia (AML).
At a glance
| Generic name | Azacitidine Injection |
|---|---|
| Also known as | CC-486, CC-486; Onureg®, Azacitidine, BMS-986345, Onureg |
| Sponsor | Ascentage Pharma Group Inc. |
| Drug class | DNA methyltransferase inhibitor |
| Target | DNA methyltransferase (DNMT) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Azacitidine inhibits DNA methyltransferase enzymes, leading to decreased methylation of DNA and reactivation of silenced tumor suppressor genes. This mechanism promotes differentiation of myelodysplastic cells and induces apoptosis in abnormal hematopoietic cells, restoring normal cell function and reducing disease progression in myelodysplastic syndromes and related disorders.
Approved indications
- Myelodysplastic syndromes (MDS)
- Chronic myelomonocytic leukemia (CMML)
- Acute myeloid leukemia (AML)
Common side effects
- Myelosuppression (anemia, thrombocytopenia, neutropenia)
- Nausea and vomiting
- Fatigue
- Fever
- Injection site reactions
- Constipation
Key clinical trials
- 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)
- Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia (PHASE1)
- Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia (PHASE2)
- Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial) (PHASE2)
- Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (EARLY_PHASE1)
- Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (PHASE1)
- Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (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:
- Azacitidine Injection CI brief — competitive landscape report
- Azacitidine Injection updates RSS · CI watch RSS
- Ascentage Pharma Group Inc. portfolio CI