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RMC-6236
RMC-6236 is a KRAS G12C inhibitor Small molecule drug developed by Revolution Medicines, Inc.. It is currently in Phase 3 development for Non-small cell lung cancer with KRAS G12C mutation, Colorectal cancer with KRAS G12C mutation, Other solid tumors with KRAS G12C mutation.
RMC-6236 is a selective inhibitor of KRAS G12C mutations that blocks oncogenic signaling in cancer cells.
RMC-6236 is a selective inhibitor of KRAS G12C mutations that blocks oncogenic signaling in cancer cells. Used for Non-small cell lung cancer with KRAS G12C mutation, Colorectal cancer with KRAS G12C mutation, Other solid tumors with KRAS G12C mutation.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | RMC-6236 |
|---|---|
| Sponsor | Revolution Medicines, Inc. |
| Drug class | KRAS G12C inhibitor |
| Target | KRAS G12C |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
RMC-6236 binds covalently to the mutant KRAS G12C protein, preventing its interaction with downstream effectors and blocking proliferative signaling. This mechanism is designed to selectively target tumors harboring KRAS G12C mutations, which are common in non-small cell lung cancer, colorectal cancer, and other solid tumors. The drug aims to provide clinical benefit in patients whose cancers depend on this specific oncogenic driver.
Approved indications
- Non-small cell lung cancer with KRAS G12C mutation
- Colorectal cancer with KRAS G12C mutation
- Other solid tumors with KRAS G12C mutation
Common side effects
- Diarrhea
- Nausea
- Fatigue
- Vomiting
- Abdominal pain
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 RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors (PHASE1, PHASE2)
- Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (PHASE3)
- Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC (PHASE1, PHASE2)
- A Study Evaluating AMG 193 in Combination With Other Therapies in Participants With Advanced Gastrointestinal, Biliary Tract, or Pancreatic Cancers With Homozygous Methylthioadenosine Phosphorylase (MTAP)-Deletion (MTAPESTRY 103) (PHASE1)
- Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors (PHASE1, PHASE2)
- 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:
- RMC-6236 CI brief — competitive landscape report
- RMC-6236 updates RSS · CI watch RSS
- Revolution Medicines, Inc. portfolio CI
Frequently asked questions about RMC-6236
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Related
- Drug class: All KRAS G12C inhibitor drugs
- Target: All drugs targeting KRAS G12C
- Manufacturer: Revolution Medicines, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-small cell lung cancer with KRAS G12C mutation
- Indication: Drugs for Colorectal cancer with KRAS G12C mutation
- Indication: Drugs for Other solid tumors with KRAS G12C mutation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing