Rasonque

(daraxonrasib)

Phase 3Small molecule

Rasonque is one of 150 small molecule programs targeting Childhood Malignant Solid Neoplasm. It is currently in Phase 3.

Indications

Total Trials

Active Trials

149

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Childhood Malignant Solid NeoplasmNot yet recruiting

Pancreatic CancerRecruiting

NSCLC (non-Small Cell Lung Cancer)Recruiting

Non-Small Cell Lung Cancer (NSCLC)Recruiting

Biliary Tract CancerNot yet recruiting

Solid TumorRecruiting

Childhood Malignant Solid NeoplasmPreclinical

Not yet recruiting

Pancreatic CancerPhase 3

Recruiting

NSCLC (non-Small Cell Lung Cancer)Phase 3

Recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 1

Recruiting

Biliary Tract CancerPhase 2

Not yet recruiting

Solid TumorPhase 2

Recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Rasonque

Revolution Medicines

Phase 3

2 2

DATROWAY

Daiichi Sankyo

Preclinical

1 3

Fludara

Sanofi

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

2 5

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 7

Navmi

SSummit Therapeutics

Preclinical

1 8

Carboplatin AUC-5

Merck & Co.

Preclinical

1 9

Soc

Pfizer

Preclinical

1 10

Tulmimetostat

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 1Recruiting

Non-Small Cell Lung Cancer (NSCLC)

NCT07349537

Q1 2029

Phase 3Recruiting

Pancreatic Cancer

NCT07491445

Q2 2029

PreclinicalRecruiting

Solid Tumor

NCT07397338

Phase 1Not yet recruiting

Pancreatic Cancer

NCT07756281

PreclinicalRecruiting

Non-Small Cell Lung Cancer (NSCLC)

NCT06128551

Q2 2030

Phase 3Recruiting

Pancreatic Cancer

NCT07805954

Clinical

Trials by Indication[1]

Pancreatic Cancer4 trials

RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT07252232·500 enrolled

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT07491445·900 enrolled

A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients With Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT07805954·400 enrolled

Show 1 more trial

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of SNV1521 in Combination With RAS Inhibition in Participants With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Not yet recruiting·SSynnovation Therapeutics, Inc.·Phase 1·NCT07756281·40 enrolled

Non-small Cell Lung Cancer (NSCLC)2 trials

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 1·NCT07349537·574 enrolled

Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors

Recruiting· Revolution Medicines logo

Revolution Medicines·Preclinical·NCT06128551·534 enrolled

Solid Tumor2 trials

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT07492680·260 enrolled

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors

Recruiting· Revolution Medicines logo

Revolution Medicines·Preclinical·NCT07397338·370 enrolled

Childhood Malignant Solid Neoplasm1 trial

A Phase 1/2 Study of Daraxonrasib (RMC-6236) in Patients With Relapsed or Refractory RAS-Driven Tumors

Not yet recruiting·CChildren's Oncology Group·Preclinical·NCT07819838·77 enrolled

PDAC1 trial

Expanded Access Program to Treat Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma With Daraxonrasib

Approved for marketing· Revolution Medicines logo

Revolution Medicines··NCT07573215

2 more indications

Biliary Tract Cancer1 trial

A Multi-Institutional Phase 2 Evaluation of Daraxonrasib in Recurrent KRAS-Mutant Biliary Tract Cancer

Not yet recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07793253·55 enrolled

NSCLC (Non-small Cell Lung Cancer)1 trial

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

Recruiting· Revolution Medicines logo

Revolution Medicines·Phase 3·NCT06881784·590 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 26, 2026

RASONQUE

NDA NDA220910

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for daraxonrasib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — daraxonrasib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for daraxonrasib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220910). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Revolution Medicines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Revolution Medicines

Rasonque

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q1 2029

Q2 2029

Q2 2030

Trials by Indication[1]

Pancreatic Cancer4 trials

Non-small Cell Lung Cancer (NSCLC)2 trials

Solid Tumor2 trials

Childhood Malignant Solid Neoplasm1 trial

PDAC1 trial

Biliary Tract Cancer1 trial

NSCLC (Non-small Cell Lung Cancer)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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