Drugs / daraxonrasib
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pancreatic ductal adenocarcinoma | 2026-07-22 | “today announced that the U.S. Food and Drug Administration (FDA) accepted for review the company’s New Drug Application (NDA) for daraxonrasib” revmed.com ↗ |
Trials 16
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Revolution Medicines, Inc. | Regulatory Revolution Medicines Announces U.S. FDA Breakthrough Therapy Designation for RASONQUE™ (daraxonrasib) in Combination with Chemotherapy for First Line Metastatic Pancreatic Cancer revmed.com ↗ |
| 2026-09-02 | Revolution Medicines, Inc. | Results New England Journal of Medicine Publishes Phase 1/2 Clinical Data on Revolution Medicines’ RASONQUE™ (daraxonrasib) in Metastatic Non-Small Cell Lung Cancer revmed.com ↗
The rates of objective response, disease control and survival observed in patients treated with RASONQUE in this Phase 1/2 study support the ongoing global, randomized pivotal RASolve 301 trial evaluating RASONQUE in previously treated RAS mutant non-small lung cancer. |
| 2026-08-26 | Revolution Medicines, Inc. | Regulatory U.S. FDA Approves Revolution Medicines’ RASONQUE™ (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer revmed.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved RASONQUE (daraxonrasib) once-daily oral tablets, for the treatment of adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. |
| 2026-08-05 | Revolution Medicines, Inc. | Regulatory Revolution Medicines Reports Second Quarter 2026 Financial Results and Update on Corporate Progress revmed.com ↗
U.S. FDA accepted daraxonrasib New Drug Application for review for previously treated metastatic pancreatic cancer following unprecedented Phase 3 RASolute 302 results |
| 2026-07-22 | Revolution Medicines, Inc. | Regulatory Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic Cancer revmed.com ↗ |
| 2026-07-07 | Revolution Medicines, Inc. | Regulatory European Medicines Agency Expedites Assessment of Revolution Medicines’ Daraxonrasib Under Phased Review Process revmed.com ↗
today announced that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has started a phased review of data on daraxonrasib, the company's investigational RAS(ON) multi-selective inhibitor. |
| 2026-07-02 | Revolution Medicines, Inc. | Results Revolution Medicines Presents Phase 1/2 Clinical Data for Zoldonrasib Combination Regimens in Patients with RAS G12D Metastatic Pancreatic Cancer at ESMO Gastrointestinal Cancers Congress 2026 revmed.com ↗
Zoldonrasib plus daraxonrasib demonstrated a manageable safety and tolerability profile that was broadly consistent with the established profile of daraxonrasib monotherapy. |
| 2026-06-08 | Tango Therapeutics, Inc. | Results Tango Therapeutics Announces Combination of Vopimetostat and Daraxonrasib Demonstrated 92% Objective Response Rate in Pancreatic Cancer tangotx.com ↗
Initial data from ongoing Phase 1/2 trial in patients with second and third line PDAC treated with vopimetostat and daraxonrasib showed 6-month PFS rate of 90% (median PFS not yet reached) suggesting durability of clinical benefit |
| 2026-05-31 | Revolution Medicines, Inc. | Results Revolution Medicines Announces ASCO Plenary Presentation Highlighting Unprecedented Results from Pivotal Phase 3 RASolute 302 Clinical Trial of Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer revmed.com ↗
Daraxonrasib exhibited a manageable safety profile and patients treated with daraxonrasib reported significantly delayed deterioration in cancer-related pain, overall global health status and quality of life, compared to those treated with chemotherapy. |
| 2026-05-06 | Revolution Medicines, Inc. | Results Revolution Medicines Announces Publication in New England Journal of Medicine of Phase 1/2 Clinical Data on Daraxonrasib in Pancreatic Cancer revmed.com ↗
Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile, in patients with previously treated metastatic RAS mutant PDAC. |
| 2026-04-21 | Revolution Medicines, Inc. | Results Revolution Medicines to Present Updated Phase 1/2 Clinical Data for Daraxonrasib in First Line Metastatic Pancreatic Cancer Across Monotherapy and Combination Cohorts at the 2026 AACR Annual Meeting revmed.com ↗
Findings from both trials support daraxonrasib’s continued evaluation in the first line setting, demonstrating manageable safety and tolerability profiles along with early signs of durable antitumor activity across monotherapy and combination approaches. |
| 2026-04-13 | Revolution Medicines, Inc. | Results Daraxonrasib Demonstrates Unprecedented Overall Survival Benefit in Pivotal Phase 3 RASolute 302 Clinical Trial in Patients with Metastatic Pancreatic Cancer revmed.com ↗
Daraxonrasib taken orally once daily demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care cytotoxic chemotherapy delivered intravenously. |
| 2025-10-27 | Revolution Medicines, Inc. | Regulatory Revolution Medicines’ RAS(ON) Multi-Selective Inhibitor Daraxonrasib Granted U.S. FDA Orphan Drug Designation in Pancreatic Cancer revmed.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer. |
| 2025-10-16 | Revolution Medicines, Inc. | Regulatory Revolution Medicines Awarded Voucher for Daraxonrasib (RMC-6236) Under FDA Commissioner's National Priority Voucher Pilot Program revmed.com ↗ |
| 2025-09-10 | Revolution Medicines, Inc. | Results Revolution Medicines Shares New Clinical Results Supporting Initiation of RASolute 303, a Global Phase 3 Registrational Trial of Daraxonrasib in First Line Metastatic Pancreatic Ductal Adenocarcinoma revmed.com ↗
Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced key clinical updates from its daraxonrasib Phase 1 clinical trials. |
| 2025-06-23 | Revolution Medicines, Inc. | Regulatory Revolution Medicines Announces FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations revmed.com ↗ |
| 2025-04-01 | Revolution Medicines, Inc. | Results Revolution Medicines to Deliver Multiple Presentations at the 2025 American Association for Cancer Research (AACR) Annual Meeting revmed.com ↗
Early reduction in circulating tumor DNA (ctDNA) is associated with clinical activity of daraxonrasib (RMC-6236) in RAS mutant non-small cell lung cancer (NSCLC) |
| 2024-12-02 | Revolution Medicines, Inc. | Results Revolution Medicines Provides Clinical Updates from its RAS(ON) Inhibitor Portfolio revmed.com ↗
Compelling Phase 1/1b update on RMC-6236 monotherapy in second-line metastatic pancreatic ductal adenocarcinoma supports ongoing Phase 3 RASolute 302 clinical trial |
| 2024-10-23 | Revolution Medicines, Inc. | Results Revolution Medicines Presents Updated Data from RMC-6236 Monotherapy Study in Patients with Advanced Pancreatic Ductal Adenocarcinoma revmed.com ↗
today announced encouraging antitumor activity and safety/tolerability data for RMC-6236, its RAS(ON) multi-selective inhibitor, in patients with previously treated pancreatic ductal adenocarcinoma (PDAC). |
| 2024-07-11 | Revolution Medicines, Inc. | Results Revolution Medicines Announces Publication Demonstrating Robust Anti-Tumor Activity of RAS(ON) Inhibitors in Preclinical Models of Refractory KRAS-Mutated Non-Small Cell Lung Cancer revmed.com ↗
The scientific paper demonstrates that the RAS(ON) multi-selective inhibitor RMC-7977 (a preclinical tool compound representative of the investigational drug candidate RMC-6236) exhibited robust and durable anti-tumor activity in multiple preclinical models of KRAS-mutated NSCLC. |
| 2024-04-09 | Revolution Medicines, Inc. | Results Revolution Medicines Announces Publication on the Discovery of and Translational Research for RMC-6236, an Investigational RAS(ON) Multi-Selective Tri-Complex Inhibitor Designed to Block Full Spectrum of Oncogenic RAS(ON) Proteins revmed.com ↗
The scientific paper details the discovery and preclinical to clinical translation for RMC-6236, an investigational RAS(ON) multi-selective inhibitor, and includes exemplary case studies from the current Phase 1/1b clinical trial demonstrating the initial anti-tumor activity of RMC-6236. |
| 2023-10-22 | Revolution Medicines, Inc. | Results Revolution Medicines Presents Promising Clinical Activity and Safety Data from Phase 1/1b Trial of RMC-6236 revmed.com ↗
These initial results were presented during a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress in Madrid, October 20-24, 2023. |
| 2023-10-13 | Revolution Medicines, Inc. | Results Revolution Medicines Presents Encouraging Clinical Data for RMC-6236 and RMC-6291 at 2023 Triple Meeting revmed.com ↗
Clinical dose escalation data for RMC-6236, a RASMULTI(ON) Inhibitor, show oral bioavailability, well-tolerated safety profile and preliminary evidence of anti-tumor activity across multiple RAS mutations |
All press releases naming this drug 31 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | daraxonrasib | “Herein, we describe the structure-guided SAR journey that led to the discovery of daraxonrasib (RMC-6236), a noncovalent, potent tri-complex inhibitor of multiple RAS mutant...” PMID 40056080 ↗ Mar 202511“Daraxonrasib (RMC-6236) is an oral RAS(ON) multiselective inhibitor that targets guanosine triphosphate-bound mutant and wild-type RAS.” PMID 42090791 ↗ May 2026 |
| Known as | RMC-6236 | “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” NCT07805954 ↗9“Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)” NCT07252232 ↗ “Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)” NCT06881784 ↗ |
| Action | Inhibit | “RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms...” NCT05379985 ↗ |
| Modality | Small molecule | “This orally bioavailable bRo5 macrocyclic molecule occupies a unique composite binding pocket comprising CypA and SWI/SWII regions of RAS(ON).” PMID 40056080 ↗ Mar 2025 |
| Route | Oral | “Patients received 10 to 400 mg of daraxonrasib orally once daily” PMID 42090791 ↗ May 2026 |
| Target | HRAS | “RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms...” NCT05379985 ↗ |
| Target | KRAS | “RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms...” NCT05379985 ↗ |
| Target | NRAS | “RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms...” NCT05379985 ↗ |