XL092

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.

EXELIXIS, INC. EXEL · Colorectal Cancer; Non-Clear Cell Renal Cell Carcinoma

Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Indications
Colorectal Cancer; Non-Clear Cell Renal Cell 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 7 Sep 20222 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 XL092. Editors add each one with its source.

Filed application

No filed application is on record for XL092. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for XL092.

Clinical trials

Trials linked to XL092
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT05678673ClinicalTrials.gov record for NCT05678673 (opens in a new tab)STELLAR-304Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell CarcinomaPhase 3Active, not recruiting317 (actual)15 Dec 2026 (estimated) No

Publications listing STELLAR-304 (1), newest first

  1. STELLAR-304: a phase III study of zanzalintinib (XL092) plus nivolumab in advanced non-clear cell renal cell carcinoma.

    Future oncology (London, England) · 2025 Mar

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.

NCT05425940ClinicalTrials.gov record for NCT05425940 (opens in a new tab)STELLAR-303Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal CancerPhase 3Active, not recruiting901 (actual)16 Jun 2026 (actual) No

Publications listing STELLAR-303 (2), newest first

  1. Zanzalintinib plus atezolizumab versus regorafenib in refractory colorectal cancer (STELLAR-303): a randomised, open-label, phase 3 trial.

    Lancet (London, England) · 2025 Nov 15

  2. STELLAR-303: randomized phase III study of zanzalintinib + atezolizumab in previously treated metastatic colorectal cancer.

    Future oncology (London, England) · 2024

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 XL092.

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.