Clinical Trial

A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Name: A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults — clinical trial record (NCT07766655)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

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Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.

Trial Details

NCT Number	NCT07766655
Lead Sponsor	Axsome Therapeutics, Inc.
Conditions	Smoking Cessation
Enrollment	705 participants
Start Date	2026-08
Primary Completion	2027-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-08-14