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daraxonrasib
daraxonrasib is a Small molecule drug developed by Revolution Medicines, Inc.. It is currently in Phase 3 development. Also known as: RMC-6236.
Daraxonrasib, also known as RMC-6236, is a RAS inhibitor drug being tested to treat advanced solid tumors, including metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12X mutations. It has received a breakthrough therapy designation from the US FDA in 2025 for the treatment of advanced solid tumors, specifically including PDAC and Non-small Cell Lung Cancer (NSCLC).
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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 | daraxonrasib |
|---|---|
| Also known as | RMC-6236 |
| Sponsor | Revolution Medicines, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5) (PHASE2)
- Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (PHASE3)
- Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (PHASE3)
- Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors (PHASE1, PHASE2)
- Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors (PHASE1, PHASE2)
- Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors (PHASE1)
- Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (PHASE3)
- Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (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:
- daraxonrasib CI brief — competitive landscape report
- daraxonrasib updates RSS · CI watch RSS
- Revolution Medicines, Inc. portfolio CI
Frequently asked questions about daraxonrasib
What is daraxonrasib?
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Is daraxonrasib also known as anything else?
What development phase is daraxonrasib in?
Related
- Manufacturer: Revolution Medicines, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: RMC-6236
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing