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MAX-40279-01
MAX-40279-01 is a Small molecule drug developed by Maxinovel Pty., Ltd.. It is currently in Phase 2 development. Also known as: Azacitidine (AZA).
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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 | MAX-40279-01 |
|---|---|
| Also known as | Azacitidine (AZA) |
| Sponsor | Maxinovel Pty., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of MAX-40279combined With KN046 in Patients With Advanced / Metastatic Solid Tumors (PHASE1, PHASE2)
- A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Max-40279 and Toripalimab in Patients With Advanced Solid Tumors (PHASE1)
- MAX-40279-01 in Patients With Advanced Solid Tumors (PHASE1)
- Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML) (PHASE1)
- A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer (PHASE2)
- A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) (PHASE1, 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:
- MAX-40279-01 CI brief — competitive landscape report
- MAX-40279-01 updates RSS · CI watch RSS
- Maxinovel Pty., Ltd. portfolio CI
Frequently asked questions about MAX-40279-01
What is MAX-40279-01?
Who makes MAX-40279-01?
Is MAX-40279-01 also known as anything else?
What development phase is MAX-40279-01 in?
Related
- Manufacturer: Maxinovel Pty., Ltd. — full pipeline
- Also known as: Azacitidine (AZA)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing