VQW-765 - (Study 3201)

Oct. 14, 2026: Vanda Pharmaceuticals (NASDAQ: VNDA) said its Phase III study VP-VQW-765-3201 (NCT07221578) of VQW-765, an alpha-7 nicotinic acetylcholine receptor partial agonist, for on-demand treatment of acute anxiety in adults with social anxiety disorder failed its primary endpoint.

The randomized, double-blind, placebo-controlled U.S. trial enrolled 546 adults at about 30 sites. After a single oral dose of VQW-765 or placebo, patients underwent the Trier Social Stress Test. The primary endpoint was distress during the performance phase in female patients, measured by Subjective Units of Distress Scale (SUDS). Results were not significant: LS mean difference -0.4 (95% CI -5.32 to 4.62), p=0.8899. The key secondary endpoint in the full male and female population also missed: LS mean difference 0.9 (95% CI -3.00 to 4.73), p=0.6605.

Vanda said the Phase III results did not confirm an earlier Phase II signal in performance anxiety. Consistent with prior studies, VQW-765 was reported safe and well tolerated. The company said the VQW-765 program is on hold pending further analysis of the full dataset.