Last reviewed 2026-05-22 · How we verify

RMC-9805

Revolution Medicines, Inc. · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

RMC-9805 is a Small molecule drug developed by Revolution Medicines, Inc.. It is currently in Phase 1 development.

RMC-9805, also known as Zoldonrasib, is an investigational drug that selectively targets the G12D mutation in KRAS dependent cancers. It functions by forming a non-covalent ligand-mediated protein-protein interaction between cyclophilin A and GTP-bound RAS, leading to the covalent modification of the mutant Asp12 residue.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	RMC-9805
Sponsor	Revolution Medicines, Inc.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors (PHASE1, PHASE2)
Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC (PHASE1, PHASE2)
Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients (PHASE1, PHASE2)
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

RMC-9805 CI brief — competitive landscape report
RMC-9805 updates RSS · CI watch RSS
Revolution Medicines, Inc. portfolio CI

Frequently asked questions about RMC-9805

What is RMC-9805?

RMC-9805 is a Small molecule drug developed by Revolution Medicines, Inc..

Who makes RMC-9805?

RMC-9805 is developed by Revolution Medicines, Inc. (see full Revolution Medicines, Inc. pipeline at /company/revolution-medicines-inc).

What development phase is RMC-9805 in?

RMC-9805 is in Phase 1.

Manufacturer: Revolution Medicines, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing