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

$AXSMPress releaseAug 31, 2026, 7:00 AM ETRead the release

Axsome Therapeutics dosed the first patient in the SUMMIT Phase 3 trial evaluating AXS-05 as a treatment for smoking cessation. The randomized, double-blind study will assess the efficacy and safety of AXS-05 compared to bupropion and placebo over a 12-week treatment period. This expansion targets a market of 34 million U.S.

Key figures

Drug Name
AXS-05
Phase Of Trial
Phase 3
Patent expiry
at least 2043
Us adult smokers
34 million
Annual smoking cost
$300 billion
Treatment duration weeks
12

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