Axsome Therapeutics Starts Phase 3 Trial of AXS-05 for Smoking Cessation

07:29 AM EDT, 08/31/2026 (MT Newswires) -- Axsome Therapeutics (AXSM) said Monday that it has dosed the first patient in its phase 3 trial evaluating AXS-05, its experimental drug intended for smoking cessation. The trial will compare AXS-05 with bupropion and placebo in adult smokers over about 12 weeks. The main goal of the study is to measure smoking abstinence at the end of the treatment period.