Daraxonrasib (RMC-6236) is an oral direct multi-selective RAS(ON) inhibitor in late-stage oncology development for RAS-driven cancers, including pancreatic ductal adenocarcinoma, NSCLC, and colorectal cancer. It is being evaluated in multiple global Phase 3 registrational trials, including first-line metastatic PDAC settings. The therapy remains investigational and unapproved in the cited source.
Tango Therapeutics said it plans to start a pivotal 300-patient randomized vopimetostat trial in second-line pancreatic cancer this year after FDA interactions. The company also reported early combination enrollment with daraxonrasib and zoldonrasib and said more monotherapy and combination data are expected later this year.
Revolution Medicines said daraxonrasib extended median survival to 13.2 months versus 6.7 months for chemotherapy in a phase 3 pancreatic cancer study. The company plans to seek FDA approval for the KRAS-targeting pill.
Daraxonrasib showed median overall survival of 13.2 months versus 6.7 months for chemotherapy in a Phase III trial in previously treated metastatic pancreatic adenocarcinoma. The once-daily pan-RAS(ON) inhibitor was generally well tolerated, and the company plans to seek FDA approval.
Revolution Medicines has initiated patient treatment in the Phase 3 RASolute 303 trial testing daraxonrasib as first-line therapy for metastatic pancreatic cancer. The company also expects top-line data from its Phase 3 RASolute 302 trial in second-line pancreatic cancer in the first half of 2026. Both trials are evaluating the oral RAS(ON) inhibitor in pancreatic ductal adenocarcinoma, a highly lethal cancer with significant unmet medical need.
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
Drug Hunter's most-accessed resources, reviews, and case studies in 2025 reflected key trends in drug discovery, including the rise of oral macrocycles, advances in new modalities, and the shift from biologics to small molecules in immunology.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07573215 |
Expanded Access Program for Daraxonrasib (RMC-6236) in Previously Treated Metastatic Pancreatic Adenocarcinoma |
AVAILABLE | |
| NCT07492680 |
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) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07491445 |
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma |
RECRUITING | PHASE3 |
| NCT07397338 |
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07349537 |
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors |
RECRUITING | PHASE1 |
| NCT07252232 |
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) |
RECRUITING | PHASE3 |
| NCT06881784 |
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) |
RECRUITING | PHASE3 |
| NCT06128551 |
Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
