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Azetukalner

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.

Xenon Pharmaceuticals Inc. XENE · Major Depressive Disorder; Bipolar Depression; Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    5

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Xenon Pharmaceuticals Inc. XENE Source: Company record for Xenon Pharmaceuticals Inc. (opens in a new tab)
Indications
Major Depressive Disorder; Bipolar Depression; Bipolar Disorder; Bipolar I Disorder; Bipolar II Disorder 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 20 Dec 20245 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 Azetukalner. Editors add each one with its source.

Filed application

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

FDA advisory committees

No FDA advisory committee meetings are on record for Azetukalner.

Clinical trials

Trials linked to Azetukalner
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07217860ClinicalTrials.gov record for NCT07217860 (opens in a new tab)An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)Phase 3Active, not recruiting400 (estimated)Jun 2029 (estimated) No
NCT07172516ClinicalTrials.gov record for NCT07172516 (opens in a new tab)X-CEEDA Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)Phase 3Active, not recruiting400 (estimated)Jun 2028 (estimated) No
NCT07076407ClinicalTrials.gov record for NCT07076407 (opens in a new tab)X-NOVA3A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)Phase 3Active, not recruiting450 (estimated)May 2027 (estimated) No
NCT06922110ClinicalTrials.gov record for NCT06922110 (opens in a new tab)X-NOVA-OLEAn Open-Label Study of Azetukalner in Major Depressive DisorderPhase 3Active, not recruiting460 (estimated)Jan 2027 (estimated) No
NCT06775379ClinicalTrials.gov record for NCT06775379 (opens in a new tab)X-NOVA2A Randomized Study of Azetukalner Versus Placebo in Major Depressive DisorderPhase 3Active, not recruiting450 (estimated)Oct 2026 (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.

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 Azetukalner.

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.