Data updated: Sep 20, 2026
RASONQUE (daraxonrasib) · REVOLUTION MEDICINES
Approved 2026-08-26
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-08-26
- Routes
- ORAL
- Dosage Forms
- TABLET
RASONQUE Approval History
Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
What RASONQUE Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07397338 | RMC-APEX-103 | Ph 1, Ph 2 | recruiting | Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors |
| NCT07252232 RASolute 304 | RMC-6236-304 | Ph 3 | recruiting | Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) |
| NCT06128551 | RMC-6291-101 | Ph 1, Ph 2 | recruiting | Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors |
| NCT07491445 RASolute 303 | RMC-6236-303 | Ph 3 | recruiting | Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma |
| NCT07492680 | CA240-0005 2025-524285-18, U1111-1330-1428 | Ph 2 | recruiting | 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) |
| NCT06881784 RASolve 301 | RMC-6236-301 | Ph 3 | recruiting | Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) |
| NCT07349537 | RMC-5127-001 | Ph 1 | recruiting | Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors |
| NCT07756281 | SNV1521-102 | Ph 1 | not yet recruiting | First in Human Study of SNV1521 With a RAS Inhibitor for People With Advanced Pancreatic Cancer |
| NCT07793253 | J2695 IRB00560104 | Ph 2 | not yet recruiting | Phase 2 Study of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer |
| NCT07805954 RASolute 309 | RMC-9805-309 | Ph 3 | recruiting | 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 |
| NCT07819838 | PEPN2611 NCI-2026-06456, PEPN2611 | Ph 1, Ph 2 | not yet recruiting | Testing the Addition of an Anti-Cancer Drug, Daraxonrasib, for Relapsed or Refractory Solid Tumors With RAS Mutations |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RASONQUE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.