Zoldonrasib

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Revolution Medicines, Inc. RVMD RVMDW · PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenosquamous Carcinoma

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    3

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Adenocarcinoma; Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenosquamous Carcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 22 May 20263 linked trials
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Zoldonrasib. Editors add each one with its source.

Filed application

No filed application is on record for Zoldonrasib. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Zoldonrasib.

Clinical trials

Trials linked to Zoldonrasib
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07805954ClinicalTrials.gov record for NCT07805954 (opens in a new tab)RASolute 309Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic AdenocarcinomaPhase 3Recruiting400 (estimated)Mar 2029 (estimated) No
NCT07777822ClinicalTrials.gov record for NCT07777822 (opens in a new tab)RASolve 308Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLCPhase 3Recruiting430 (estimated)Oct 2029 (estimated) No
NCT07621718ClinicalTrials.gov record for NCT07621718 (opens in a new tab)RASolute 305Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )Phase 3Recruiting670 (estimated)30 Dec 2028 (estimated) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

No FDA approvals on record for this drug.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as Zoldonrasib.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.