What Is Daraxonrasib?
Daraxonrasib — you’ll also see it called RMC-6236 — is an oral cancer drug being developed by Revolution Medicines. It’s designed to treat pancreatic cancer and other solid tumors that carry RAS mutations.
Here’s why that matters: over 90% of pancreatic cancers are driven by a faulty RAS protein. For decades, researchers knew this was the problem. They just couldn’t figure out how to stop it. The protein was considered “undruggable” — its shape didn’t give small-molecule drugs anywhere to grab onto.
Daraxonrasib is a credible answer to that problem.
In 2026, the Phase 3 RASolute 302 trial showed that daraxonrasib nearly doubled overall survival compared to standard chemotherapy in patients with previously treated metastatic pancreatic cancer. Revolution Medicines announced plans to file a New Drug Application (NDA) with the FDA in April 2026. The FDA has already issued a “safe to proceed” letter for an expanded access program, so some eligible patients can get the drug now, before official approval.
KRAS Mutations and Pancreatic Cancer — Why This Is So Hard
To understand what daraxonrasib actually does, it helps to know a bit about KRAS.
KRAS is a protein that tells cells when to grow. In a healthy body, it switches on and off normally. When it mutates, it gets stuck in the “on” position — permanently signaling cells to divide, even when they shouldn’t. That’s cancer, in a nutshell.
A few things worth knowing about KRAS in pancreatic cancer:
- More than 90% of pancreatic ductal adenocarcinomas (PDAC) carry an activating RAS mutation.
- The most common subtypes are KRAS G12D, G12V, and G12R — all in the G12 family.
- KRAS G12C (the mutation that drugs like sotorasib and adagrasib target) is actually more common in lung cancer. It does show up in some pancreatic cancers, but it’s not the dominant subtype there.
- Earlier KRAS drugs only worked on G12C. That left the vast majority of pancreatic cancer patients without a targeted option.
Daraxonrasib targets G12D, G12V, G12R, and other RAS mutations — not just G12C. That’s the difference that makes it so relevant to pancreatic cancer specifically.
How Does Daraxonrasib Work?
The daraxonrasib mechanism of action differs from earlier KRAS-targeted therapies.
Most targeted cancer drugs work by binding to a protein when it’s switched off, locking it in place so it can’t turn on. Daraxonrasib does the opposite. It targets RAS while it’s already active — while it’s in the “on” state, driving tumor growth. Revolution Medicines calls this an RAS(ON) inhibitor approach.
Here’s how it works, step by step:
Step 1: Daraxonrasib binds to a protein already found in the body called Cyclophilin A (CypA). Together, they form a two-part complex.
Step 2: That two-part complex then latches onto RAS while RAS is actively signaling — catching it in the act, essentially.
Step 3: This three-part structure (drug + CypA + RAS) blocks RAS from activating the downstream pathways — RAF–MEK–ERK and PI3K–AKT — that cancer cells depend on to grow and survive.
Earlier KRAS G12C inhibitors like sotorasib and adagrasib bind to inactive RAS and only work on the G12C mutation. Daraxonrasib binds to active RAS and works across multiple mutation subtypes at once. That makes it a pan-RAS inhibitor — a much broader approach, and far more useful for pancreatic cancer patients where G12C is relatively rare.
Daraxonrasib Clinical Trial Results — What the Research Actually Shows
The daraxonrasib clinical trial data have been building quickly, with results published in the New England Journal of Medicine and presented at major oncology meetings.
Phase 1/2 Trial (RMC-6236-001)
The early-phase trial enrolled patients with previously treated RAS-mutated solid tumors, including a dedicated pancreatic cancer group.
Key numbers from the 168 PDAC patients treated at doses up to 300 mg:
- Among 26 patients with KRAS G12-mutated PDAC receiving second-line daraxonrasib at 300 mg, the objective response rate (ORR) was 35%.
- Across all RAS-mutant metastatic PDAC patients (n=38), the ORR was 47%, and the disease control rate was 92%.
- The 6-month progression-free survival rate was 71%.
These numbers were strong enough to justify moving straight to a Phase 3 trial.
Phase 3 Trial (RASolute 302) — The Results That Changed Things
The Phase 3 RASolute 302 trial (NCT06625320) compared daraxonrasib head-to-head against standard chemotherapy in previously treated metastatic PDAC patients. Topline results came out in April 2026. The full data were published in the New England Journal of Medicine in May 2026.
What the trial found:
- Median overall survival: 13.2 months with daraxonrasib vs. 6.7 months with chemotherapy.
- 60% reduction in the risk of death (Hazard Ratio 0.40; p < 0.0001).
- The trial hit all primary and key secondary endpoints — PFS, OS, ORR, and quality of life.
- Benefits held up in patients with RAS G12 mutations and in patients without identified RAS mutations.
And daraxonrasib is taken as a once-daily oral pill. For someone already dealing with metastatic pancreatic cancer, not having to go in for IV infusions matters a lot.
For a disease where median survival in the second-line setting has historically been around 6–7 months, these are numbers that don’t come along often.
Daraxonrasib FDA Approval Status
As of June 2026, daraxonrasib is not FDA-approved. But the regulatory process is moving faster than usual for a reason.
Timeline of what’s happened:
- June 2025: FDA granted Breakthrough Therapy Designation for previously treated metastatic PDAC with KRAS G12 mutations.
- October 2025: The FDA granted a National Priority Voucher designation.
- April 2026: Revolution Medicines announced plans to file a New Drug Application (NDA) under the FDA’s Commissioner’s National Priority Voucher pilot program.
- May 1, 2026: The FDA issued a “safe to proceed” letter authorizing an Expanded Access Treatment Protocol — meaning eligible patients in the U.S. can access daraxonrasib before formal approval.
- Orphan Drug Designation has also been granted.
With Breakthrough Therapy Designation, a strong Phase 3 dataset, and an NDA in progress, a daraxonrasib FDA approval decision in late 2026 or sometime in 2027 is plausible. Your oncologist will have the most current update on timing.
Daraxonrasib Side Effects — What to Know Going In
Daraxonrasib does have side effects. No cancer drug does. But the clinical trial data suggest the profile is manageable — and in some respects, more tolerable than standard chemotherapy.
Most common side effects (occurring in ≥10% of patients):
- Rash — the most frequently reported; preventive skincare can help
- Diarrhea
- Nausea
- Mouth sores (stomatitis/mucositis)
- Vomiting
- Fatigue
How serious are they?
In the Phase 1/2 study, 96% of patients experienced at least one treatment-related side effect of any grade. Serious (grade 3 or higher) events occurred in roughly 30–34% of patients. No patients in the 300 mg cohort stopped treatment entirely due to side effects, though 48% needed dose adjustments.
In the Phase 3 trial, grade 3 or higher adverse events occurred in 61.8% of daraxonrasib patients vs. 69.6% of chemotherapy patients — so the toxicity burden was comparable or slightly better with daraxonrasib.
Most side effects were mild to moderate and handled with supportive care. Tell your care team about any new or worsening symptoms quickly — don’t wait for your next appointment.
Daraxonrasib Cost, Price, and How to Access It
What Will It Cost?
There’s no official daraxonrasib price yet — the drug isn’t approved, so Revolution Medicines hasn’t announced one. Once it is, expect pricing in the range of other targeted oncology therapies, which often run $10,000–$30,000+ per month in the U.S. without insurance. Most companies launch patient assistance programs alongside approval; ask your oncology team about options when the time comes.
How Can You Get Daraxzanib Now?
Two paths exist right now:
1. Clinical trials: The RASolute 302 trial may still have open sites, and the upcoming first-line RASolute 303 trial will be enrolling. Search for “daraxonrasib” or “NCT06625320” on ClinicalTrials.gov to find studies near you.
2. Expanded Access Program (EAP): As of May 1, 2026, the FDA authorized an EAP for patients with previously treated RAS-mutated metastatic PDAC who aren’t eligible for a clinical trial. Contact Revolution Medicines directly or ask your oncologist to initiate the application.
Your oncologist is the right first call — they can tell you which path fits your situation.
About Revolution Medicines
Revolution Medicines is a late-stage oncology company based in Redwood City, California. Their focus is on cancers driven by mutations in the RAS protein family — KRAS, HRAS, NRAS. Daraxonrasib is their lead program, but they have more in the pipeline:
- Zoldonrasib (RMC-9805): A selective KRAS G12D inhibitor being studied in combination with daraxonrasib.
- RASolute 303: A Phase 3 first-line trial for metastatic PDAC, comparing daraxonrasib alone, daraxonrasib plus chemotherapy, and chemotherapy alone.
They’ve built their platform specifically around RAS(ON) inhibition — the approach that daraxonrasib is based on — and are pushing toward global regulatory submissions now.
FAQs
What is daraxonrasib used for?
Daraxonrasib (RMC-6236) is being developed primarily for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). It targets RAS mutations — especially KRAS G12 variants — found in over 90% of pancreatic cancers. It’s also being studied in other RAS-mutated solid tumors, including non-small cell lung cancer.
How does daraxonrasib work?
Daraxonrasib is a RAS(ON) multi-selective tri-complex inhibitor. It binds to a naturally occurring protein called Cyclophilin A, and that complex then attaches to RAS while RAS is actively signaling. This blocks the downstream pathways (RAF–MEK–ERK and PI3K–AKT) that cancer cells need to survive and grow. Unlike earlier KRAS G12C inhibitors, it targets multiple RAS mutation subtypes at once.
Is daraxonrasib FDA-approved?
Not yet, as of June 2026. It holds FDA Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic PDAC. Revolution Medicines has filed for NDA review, and an Expanded Access Program is now active for eligible patients.
What are daraxonrasib’s side effects?
The most common are rash, diarrhea, nausea, mouth sores, vomiting, and fatigue. Most are mild to moderate. Serious side effects (grade 3 or higher) occurred in about 30–34% of Phase 1/2 patients. The Phase 3 data showed a comparable or slightly better safety profile versus standard chemotherapy.
How much does daraxonrasib cost?
No price has been announced yet. Once approved, pricing will likely be in line with other targeted oncology drugs. Patient assistance programs typically become available at launch — your oncology team can help navigate that when the time comes.
How can I get access to daraxonrasib?
Two options: enroll in a clinical trial (search “daraxonrasib” or “NCT06625320” on ClinicalTrials.gov), or apply for the Expanded Access Program (EAP), which the FDA authorized in May 2026. Talk to your oncologist first — they’ll know which option fits your case.
Bottom Line
Daraxonrasib (RMC-6236) is the most promising development in pancreatic cancer treatment in a long time. Not because of hype — because of the actual numbers. Doubling median overall survival against chemotherapy, in a disease that has resisted progress for decades, is genuinely unusual.
It’s not approved yet. But an active NDA filing, Breakthrough Therapy Designation, and a working Expanded Access Program mean eligible patients don’t necessarily have to wait. If you or someone you love is dealing with metastatic pancreatic cancer, a conversation with an oncologist at a major cancer center about daraxonrasib — whether through a trial or expanded access — is worth having now.
Medical Disclaimer
This article is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Daraxonrasib is an investigational drug not yet FDA-approved as of June 2026. Clinical data are sourced from published research and company press releases. Individual outcomes vary. Always consult a qualified oncologist before making treatment decisions.
