Washington – October 14, 2026 -- Vanda Pharmaceuticals (Nasdaq: VNDA) has put its VQW-765 program on hold after the Phase III Study 3201 in adults with social anxiety disorder missed its primary endpoint, and the company said the data did not confirm earlier Phase II findings.
Phase III trial misses primary and key secondary endpoints
Study 3201 (NCT07221578) tested VQW-765 as an on-demand treatment for acute anxiety. Female participants who received the drug showed no statistically significant difference in distress from those who received placebo during the performance phase of the Trier Social Stress Test (TSST). The primary endpoint was measured on the Subjective Units of Distress Scale (SUDS), a 0-to-100 self-rating of nervousness.
The study also missed its key secondary endpoint, SUDS during the TSST performance phase in the full male and female population.
Study enrolled 546 adults at about 30 U.S. sites
The multicenter, randomized, double-blind, placebo-controlled trial enrolled 546 adults aged 18 to 65 with a current social anxiety disorder diagnosis and elevated baseline scores on the Liebowitz Social Anxiety Scale and Public Speaking Anxiety Scale. Participants received a single oral dose of VQW-765 or placebo in a 1:1 ratio, then completed the TSST. The test has participants prepare and deliver an interview-style presentation to a panel that offers no feedback or encouragement.
Result fails to replicate Phase II signal
Study 3201 was designed to confirm Phase II Study 2201. In that trial, participants with a history of performance anxiety who received VQW-765 reported numerically lower stress levels during the TSST than those on placebo. The Phase III results did not confirm those findings.
Vanda said VQW-765 was safe and well tolerated, consistent with prior studies.
Vanda CEO cites disappointment; analysis continues
Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman, said he was disappointed that the study failed to confirm the earlier Phase II findings. The program remains on hold pending further analysis of the full Study 3201 dataset.
Drug targets an indication with no FDA-approved therapy
VQW-765 is a small-molecule alpha 7 nicotinic acetylcholine receptor partial agonist, licensed to Vanda from Novartis and formerly known as AQW-051. Vanda estimates that over 20% of the U.S. population experiences debilitating performance anxiety. The company says no FDA-approved drug treatment exists for the condition, and general anti-anxiolytics tend to be sedating, which is not preferred in performance situations.