Daraxonrasib
Also known as Rasonque
Revolution Medicines, Inc. RVMD RVMDW · PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma Metastatic
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
4
From ClinicalTrials.gov
Latest FDA action
Approved
NDA220910,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Revolution Medicines, Inc. RVMD RVMDW Source: Company record for Revolution Medicines, Inc. (opens in a new tab)
- Indications
- PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma Metastatic Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 220910 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 220910 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 6 May 20254 linked trials
- Filed Completed
- Approved Current stageFirst approval 26 Aug 2026
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Daraxonrasib. Editors add each one with its source.
Filed application
No filed application is on record for Daraxonrasib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Daraxonrasib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT07805954ClinicalTrials.gov record for NCT07805954 (opens in a new tab)RASolute 309 | 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 | 400 (estimated) | Mar 2029 (estimated) | No |
| NCT07491445ClinicalTrials.gov record for NCT07491445 (opens in a new tab)RASolute 303 | Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma | Phase 3 | Recruiting | 900 (estimated) | Jun 2028 (estimated) | No |
| NCT07252232ClinicalTrials.gov record for NCT07252232 (opens in a new tab)RASolute 304 | Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) | Phase 3 | Recruiting | 500 (estimated) | 10 May 2029 (estimated) | No |
| NCT06881784ClinicalTrials.gov record for NCT06881784 (opens in a new tab)RASolve 301 | Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) | Phase 3 | Recruiting | 590 (estimated) | 1 Dec 2027 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA220910Action letter for NDA220910 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
OpinionOrphan medicine
Rasonque (EMEA/H/C/007122)
- Authorised
- Not given
- Therapeutic area
- Pancreatic Neoplasms
- Marketing authorisation holder
- Revolution Medicines Netherlands B.V.
- Active substance (INN)
- Daraxonrasib
- ATC code
- L01XX
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Rasonque (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 220910 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT07805954 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT07491445 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT07252232 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06881784 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA220910 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.