COMPANY
REVOLUTION Medicines
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start Phase 3: Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma source ↗
- FDA FDA New drug/biologic (novel): RASONQUE (daraxonrasib) — NDA220910, Aug 26, 2026. Applicant at approval: Revolution Medicines, Incorporated. source ↗
- Trial start Phase 3: Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC source ↗
- Trial start Phase 3: Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute source ↗
- Raise Follow-on offering: $2.2B (total, as published), announced Apr 17, 2026. Source: company release on GlobeNewswire. source ↗
- Trial start Phase 3: Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma source ↗
- Trial start Phase 1/Phase 2: Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors source ↗
- Trial start Phase 1: Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors source ↗
- Trial start Phase 3: Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) source ↗
- Trial start Phase 3: Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) source ↗
- Raise Follow-on offering: $862.5M (total, as published), announced Dec 5, 2024. Source: company release on GlobeNewswire. source ↗
- Trial start 3: Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) source ↗
- Trial start Phase 1/Phase 2: Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors source ↗
- Trial start Phase 1/Phase 2: Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC source ↗
- Trial start Phase 1/Phase 2: Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors source ↗
- Trial start Phase 1: Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors source ↗
- Trial start Phase 1: Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors source ↗
- Trial start Phase 1/Phase 2: Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS source ↗
- Trial start Phase 2: Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies source ↗
- Trial start Phase 1: Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors source ↗
- Trial start Phase 1/Phase 2: Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC source ↗
- Trial start Phase 1: Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors source ↗
Upcoming milestones
- Dec 31, 2026 (ESTIMATED) · Phase 1 · Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors · NCT06040541
- Mar 31, 2027 (ESTIMATED) · Phase 1 · Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors · NCT05462717
- May 31, 2027 (ESTIMATED) · Phase 1/Phase 2 · Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS · NCT05379985
- 2027-06 (ESTIMATED) · Phase 1/Phase 2 · Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC · NCT06162221
- Dec 1, 2027 (ESTIMATED) · Phase 3 · Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) · NCT06881784
- 2028-04 (ESTIMATED) · Phase 1 · Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors · NCT07349537
- 2028-06 (ESTIMATED) · Phase 3 · Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma · NCT07491445
- Sep 30, 2028 (ESTIMATED) · Phase 1/Phase 2 · Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors · NCT06445062
Funding
Clinical trials (lead sponsor) 20
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07491445 | Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma | Phase 3 | Recruiting | Mar 9, 2026 | 2028-06 (estimated) |
| NCT06881784 | Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) | Phase 3 | Recruiting | May 6, 2025 | Dec 1, 2027 (estimated) |
| NCT07621718 | Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 ) | Phase 3 | Recruiting | May 22, 2026 | Dec 30, 2028 (estimated) |
| NCT07252232 | Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) | Phase 3 | Recruiting | Dec 15, 2025 | May 10, 2029 (estimated) |
| NCT06128551 | Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors | Phase 1/Phase 2 | Recruiting | Nov 14, 2023 | 2028-12 (estimated) |
| NCT06445062 | Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors | Phase 1/Phase 2 | Recruiting | May 24, 2024 | Sep 30, 2028 (estimated) |
| NCT07349537 | Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors | Phase 1 | Recruiting | Jan 8, 2026 | 2028-04 (estimated) |
| NCT07805954 | Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma | Phase 3 | Recruiting | Aug 28, 2026 | 2029-03 (estimated) |
| NCT07573215 | Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma | Not listed | Approved for marketing | Not listed | Not listed |
| NCT07777822 | Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC | Phase 3 | Recruiting | Aug 14, 2026 | 2029-10 (estimated) |
| NCT07397338 | Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors | Phase 1/Phase 2 | Recruiting | Jan 30, 2026 | 2029-05 (estimated) |
| NCT06162221 | Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC | Phase 1/Phase 2 | Recruiting | Jan 18, 2024 | 2027-06 (estimated) |
| NCT06040541 | Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors | Phase 1 | Recruiting | Sep 7, 2023 | Dec 31, 2026 (estimated) |
| NCT06625320 | Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) | 3 | Active, not recruiting | Oct 16, 2024 | 2026-06 (estimated) |
| NCT05462717 | Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | Phase 1 | Active, not recruiting | Sep 19, 2022 | Mar 31, 2027 (estimated) |
| NCT05379985 | Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS | Phase 1/Phase 2 | Recruiting | May 31, 2022 | May 31, 2027 (estimated) |
| NCT05054725 | Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies | Phase 2 | Completed | Dec 30, 2021 | Jul 3, 2024 (actual) |
| NCT04774952 | Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors | Phase 1 | Completed | Apr 7, 2021 | May 6, 2024 (actual) |
| NCT03989115 | Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC | Phase 1/Phase 2 | Completed | Jul 2, 2019 | Feb 8, 2022 (actual) |
| NCT03634982 | Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors | Phase 1 | Unknown status (ClinicalTrials.gov) | Sep 28, 2018 | Mar 31, 2023 (estimated) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): RASONQUE (daraxonrasib) — NDA220910, Aug 26, 2026. Applicant at approval: Revolution Medicines, Incorporated. source ↗
Raises and investors new
- InvestorListed in the portfolio of Bain Capital Life Sciences (captured Oct 12, 2026). portfolio page ↗