Olomorasib

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.

ELI LILLY & Co LLY · Carcinoma, Non-Small-Cell Lung

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indication
Carcinoma, Non-Small-Cell Lung 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 27 Mar 20251 linked trial
  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 Olomorasib. Editors add each one with its source.

Filed application

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

FDA advisory committees

No FDA advisory committee meetings are on record for Olomorasib.

Clinical trials

Trials linked to Olomorasib
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06890598ClinicalTrials.gov record for NCT06890598 (opens in a new tab)SUNRAY-02Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung CancerPhase 3Recruiting700 (estimated)May 2029 (estimated) No

Publications listing SUNRAY-02 (1), newest first

  1. SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy.

    Future oncology (London, England) · 2026 Oct 1

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

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

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

Related news

Sources

Record updated .

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