NCT06775379

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

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-NOVA2 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: 2024-12-20
• Primary completion: 2026-08-01
• Completion: 2026-10-01
• First posted: 2025-01-15
• Last updated: 2025-10-22

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated drug study