Azetukalner

Phase 3Small molecule

XXenon Pharmaceuticals Inc.

Azetukalner is one of 100 small molecule programs targeting Bipolar Depression. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bipolar DepressionEnrolling by invitation

Bipolar DisorderRecruiting

Major Depressive DisorderEnrolling by invitation

Bipolar DepressionPhase 3

Enrolling by invitation

Bipolar DisorderPhase 3

Recruiting

Major Depressive DisorderPhase 3

Enrolling by invitation

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 2

Ketalar

Boehringer Ingelheim

Phase 3

3 3

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 4

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 5

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 6

Psilocybin

COMPASS Pathways

Phase 3

11 7

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 8

Aticaprant

Johnson & Johnson

Phase 3

4 9

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

2 10

Azetukalner

XXenon Pharmaceuticals Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Major Depressive Disorder

NCT06775379

Q3 2027

Phase 3Recruiting

Major Depressive Disorder

NCT07076407

Q3 2028

Phase 3Recruiting

Bipolar Disorder

NCT07172516

Clinical

Trials by Indication[1]

Major Depressive Disorder3 trials

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

Recruiting·XXenon Pharmaceuticals Inc.·Phase 3·NCT07076407·450 enrolled

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder

Enrolling by invitation·XXenon Pharmaceuticals Inc.·Phase 3·NCT06922110·460 enrolled

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder

Recruiting·XXenon Pharmaceuticals Inc.·Phase 3·NCT06775379·450 enrolled

Bipolar Disorder1 trial

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Recruiting·XXenon Pharmaceuticals Inc.·Phase 3·NCT07172516·400 enrolled

Bipolar Depression1 trial

A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

Enrolling by invitation·XXenon Pharmaceuticals Inc.·Phase 3·NCT07217860·400 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Azetukalner. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Azetukalner compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Azetukalner. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Xenon Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: XXenon Pharmaceuticals Inc.

Azetukalner

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q3 2028

Trials by Indication[1]

Major Depressive Disorder3 trials

Bipolar Disorder1 trial

Bipolar Depression1 trial

References

Drug Info

Quick Facts

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