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azacitidine for injectable suspension
azacitidine for injectable suspension is a Small molecule drug developed by US Oncology Research. It is currently in Phase 2 development. Also known as: Vidaza™.
Azacitidine is a small molecule inhibitor of DNA (cytosine-5)-methyltransferase 3A, a class of inhibitor. It is used to treat conditions such as Acute Myeloid Leukaemia, Myelodysplastic Syndrome, and Chronic Myelomonocytic Leukemia.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | azacitidine for injectable suspension |
|---|---|
| Also known as | Vidaza™ |
| Sponsor | US Oncology Research |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) (PHASE3)
- Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies (PHASE1, PHASE2)
- A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy. (PHASE1)
- Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer (PHASE1, PHASE2)
- A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies (PHASE1, PHASE2)
- Study of Elenestinib (BLU-263) in Advanced Systemic Mastocytosis (AdvSM) and and Other KIT Altered Hematologic Malignancies (PHASE1)
- Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML (PHASE3)
- Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants. (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:
- azacitidine for injectable suspension CI brief — competitive landscape report
- azacitidine for injectable suspension updates RSS · CI watch RSS
- US Oncology Research portfolio CI
Frequently asked questions about azacitidine for injectable suspension
What is azacitidine for injectable suspension?
Who makes azacitidine for injectable suspension?
Is azacitidine for injectable suspension also known as anything else?
What development phase is azacitidine for injectable suspension in?
Related
- Manufacturer: US Oncology Research — full pipeline
- Also known as: Vidaza™
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing