Axsome posts ADVANCE-2 agitation results; smoking cessation trial recruiting
Axsome Therapeutics reported Phase 3 results for AXS-05 in Alzheimer's agitation and disclosed a recruiting Phase 3 trial testing AXS-05 for smoking cessation.
Axsome Therapeutics had two notable trial updates this week.
- ADVANCE-2, a Phase 3 trial of AXS-05 for agitation linked to Alzheimer's disease, posted results on 2026-08-13. On the Cohen-Mansfield Agitation Inventory, AXS-05 showed a change of -13.85 versus -12.77 for placebo, with a p-value of 0.407.1 The trial enrolled 408 participants.1
- SUMMIT, a Phase 3 trial testing AXS-05 against placebo and bupropion for smoking cessation in adults, is recruiting, with an actual start date of 2026-08-27 and first posting on 2026-08-14. The trial plans to enroll 705 participants.2 Its primary outcome is the 4-Week Continuous Smoking Abstinence Rate, measured from Weeks 9 to 12.2
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