NCT07076407

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Azetukalner	Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
DRUG	Placebo	Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Timeline

• Start date: 2025-07-08
• Primary completion: 2027-05-01
• Completion: 2027-07-01
• First posted: 2025-07-22
• Last updated: 2026-04-08

Locations

42 sites across 5 countries: United States, Finland, Poland, Romania, Slovakia

Regulatory

• FDA-regulated drug study