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Volitinib
Volitinib is a Small molecule drug developed by Hutchison Medipharma Limited. It is currently in Phase 2 development. Also known as: HMPL-504, AZD6094.
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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 | Volitinib |
|---|---|
| Also known as | HMPL-504, AZD6094 |
| Sponsor | Hutchison Medipharma Limited |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC (PHASE2)
- Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib (PHASE2)
- AZD9291 in Combination With Ascending Doses of Novel Therapeutics (PHASE1)
- Savolitinib vs. Sunitinib in MET-driven PRCC. (PHASE3)
- Savolitinib Combine With Durvalumab in EGFR Wild-type Locally Advanced or Metastatic NSCLC (PHASE2)
- Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2) (PHASE2)
- Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification (PHASE2)
- Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC (PHASE3)
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:
- Volitinib CI brief — competitive landscape report
- Volitinib updates RSS · CI watch RSS
- Hutchison Medipharma Limited portfolio CI
Frequently asked questions about Volitinib
What is Volitinib?
Who makes Volitinib?
Is Volitinib also known as anything else?
What development phase is Volitinib in?
Related
- Manufacturer: Hutchison Medipharma Limited — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: HMPL-504, AZD6094
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing