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Azacitadine
Azacitadine is a Small molecule drug developed by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. It is currently in Phase 3 development. Also known as: Vidaza.
Azacitidine is used to treat Myelodysplastic Syndrome, Acute Myeloid Leukemia, and Head and Neck Squamous Cell Carcinoma. It is often studied in combination with pracinostat, a medication that is also being investigated for these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Azacitadine |
|---|---|
| Also known as | Vidaza |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
- Genotype-guided Targeted Agents Plus EZH2i for Primary Refractory PTCL (PHASE1, PHASE2)
- Venetoclax to Augment Epigenetic Modification and Chemotherapy (PHASE1)
- Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy (PHASE2)
- Maintenance Low Dose 5'-Azacitidine Post T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Myelodysplastic Syndrome and Acute Myelogenous Leukemia With High Risk for Post-Transplant Relapse (PHASE2)
- Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PHASE2)
- Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients (PHASE2)
- Window Trial 5-aza in HNSCC, T-tare (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:
- Azacitadine CI brief — competitive landscape report
- Azacitadine updates RSS · CI watch RSS
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins portfolio CI
Frequently asked questions about Azacitadine
What is Azacitadine?
Who makes Azacitadine?
Is Azacitadine also known as anything else?
What development phase is Azacitadine in?
Related
- Manufacturer: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Vidaza
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing