GlobeNewswire·Aug 31, 2026, 7:00 AM ET

Axsome Therapeutics Initiates SUMMIT Phase 3 Trial of AXS-05 in Smoking Cessation

Axsome Therapeutics announced that the first patient has been dosed in the SUMMIT Phase 3 trial of AXS-05 for smoking cessation.
The SUMMIT trial is a randomized, double-blind, active- and placebo-controlled, multicenter study assessing the efficacy & safety of AXS-05 in adult smokers over approximately 12 weeks.
Participants will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo, with the primary endpoint being smoking abstinence at the end of the 12-week treatment period.
AXS-05 is an oral investigational NMDA receptor antagonist, sigma-1 agonist, & aminoketone CYP2D6 inhibitor covered by a patent estate extending to at least 2043.
AXS-05 is currently approved in the U.S. for major depressive disorder & agitation associated with dementia due to Alzheimer's disease but is not approved for smoking cessation.
Smoking remains the single largest cause of preventable disease in the U.S., accounting for 1 in 5 deaths & costing over $300 billion annually.
Approximately 34 million U.S. adults smoke cigarettes, with nearly 70% expressing a desire to quit, yet only 3-5% of those attempting to quit without assistance succeed for 6-12 months.