RMC-9805

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 12, 2025

RMC-9805 Medication Report

Name: RMC-9805 Name (English): RMC-9805

Mechanism of Action: RMC-9805 is an orally bioavailable covalent tri-complex inhibitor that selectively targets the active, GTP-bound form of the KRAS G12D mutation (KRASG12D(ON)). Upon oral administration, RMC-9805 first non-covalently binds to cyclophilin A, forming a binary complex. This complex then covalently and irreversibly binds to the KRASG12D(ON) protein at the Asp-12 residue. This interaction prevents KRAS G12D-mediated signaling and the activation of downstream survival pathways, leading to apoptosis in tumor cells expressing this mutation. Additionally, RMC-9805 may abrogate the suppressive tumor microenvironment and enhance anti-tumor immune responses.

Indications and Usage: RMC-9805 is an investigational drug currently being evaluated in Phase 1 clinical trials for the treatment of advanced solid tumors harboring the KRAS G12D mutation. Preliminary data suggest potential activity in:

Non-small cell lung cancer (NSCLC)
Pancreatic ductal adenocarcinoma (PDAC)
Colorectal cancer (CRC)

Clinical Trial Information: RMC-9805 is being investigated in several Phase 1/1b clinical trials, including:

NCT06040541: A multicenter, open-label study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
Other platform studies are evaluating RMC-9805 in combination with standard-of-care therapies or other novel agents in gastrointestinal solid tumors and advanced RAS-mutated NSCLC.

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients	2025/04/10	NCT06922591	Phase 1	Recruiting	Tango Therapeutics, Inc.
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors	2024/06/06	NCT06445062	Phase 1	Recruiting	Revolution Medicines, Inc.
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC	2023/12/08	NCT06162221	Phase 1	Recruiting	Revolution Medicines, Inc.
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors	2023/09/15	NCT06040541	Phase 1	Recruiting	Revolution Medicines, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Revolution Medicines Partners with Iambic Therapeutics in $25M AI-Driven Drug Discovery Collaboration for RAS-Addicted Cancers

18 days ago

Revolution Medicines and Iambic Therapeutics announced a multi-year collaboration in July 2025 to develop novel drug candidates using AI-driven discovery platforms targeting RAS-addicted cancers.

Revolution Medicines and Summit Therapeutics Launch Clinical Collaboration to Test RAS Inhibitor Combinations with Bispecific Antibody

a month ago

Revolution Medicines and Summit Therapeutics announced a clinical collaboration to evaluate three RAS(ON) inhibitors in combination with ivonescimab, a PD-1/VEGF bispecific antibody, across multiple solid tumor types.

Revolution Medicines Secures $2 Billion Funding Deal with Royalty Pharma for RAS Cancer Drug Development

a month ago

Revolution Medicines partnered with Royalty Pharma on a $2 billion flexible funding agreement to support global development and commercialization of its RAS(ON) inhibitor portfolio for cancer treatment.

Revolution Medicines Advances First-in-Class KRAS(G12D) Molecular Glue Inhibitor RMC-9805 with Novel Cyclophilin A Mechanism

2 months ago

Revolution Medicines has developed RMC-9805, a first-in-class covalent KRAS(G12D)(ON) molecular glue inhibitor that targets the previously "undruggable" KRAS(G12D) mutant using a cyclophilin A-recruiting tricomplex mechanism.

Revolution Medicines Reports Promising Results for Zoldonrasib in KRAS G12D Mutant Lung Cancer

3 months ago

• Revolution Medicines announced new clinical data for zoldonrasib (RMC-9805) showing a 61% objective response rate in patients with KRAS G12D mutant non-small cell lung cancer at the AACR Annual Meeting. • The RAS(ON) G12D-selective inhibitor demonstrated an acceptable safety profile with primarily Grade 1 or 2 adverse events and a favorable mean dose intensity of 98% in the Phase 1 study. • These results build on earlier promising data in pancreatic ductal adenocarcinoma, supporting further evaluation of zoldonrasib as both monotherapy and in combination treatments for these difficult-to-treat cancers.

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