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

2025-523202-32-00 · tracked via the Priya Life Science EU tracker

Sponsor

Xenon Pharmaceuticals Inc.

Sponsor type

Pharmaceutical company

Therapeutic area

Mental Disorders

Decision date

26/01/2026

Enrollment target

162

Sites

Spain, Czechia, Slovakia, Romania, Poland, Finland, Germany

Condition studied

Major Depressive Disorder

Investigational medicinal product(s)

XPF-010Placebo to match XPF-010

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Change from baseline in the HAMD-17 score at Week 6.

Endpoint detail

Change from baseline in the SHAPS score at Week 6, Change from baseline in the HAMD-17 score at Week 1, Change from baseline in the CGI-S score at Week 6

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523202-32-00 on CTIS ↗ ← All trials in the EU