# Vanda Puts VQW-765 Anxiety Program on Hold After Phase III Trial Miss

By John Kim

Canonical URL: https://www.tokenpost.com/news/business/32480
Published: 2026-10-15T12:00:10.000Z
Updated: 2026-10-15T12:00:10.000Z
Section: Business

> The trial missed its primary endpoint, which measured distress among women with social anxiety disorder; a secondary analysis of all participants also found no significant difference.

Vanda Pharmaceuticals put its VQW-765 program on hold Oct. 14 after a Phase III trial missed its primary endpoint, which assessed distress scores among women with social anxiety disorder. The secondary analysis of all participants also found no significant difference between the drug and placebo.

Study 3201 randomized 546 adults ages 18 to 65 at about 30 U.S. sites to receive one oral dose of VQW-765 or placebo before a public-speaking stress test. The primary endpoint used the 0-to-100 Subjective Units of Distress Scale (SUDS). Women’s estimated mean scores were 65.6 with the drug and 66.0 with placebo, a difference of -0.4 points (95% confidence interval, -5.32 to 4.62; p=0.8899).

In the secondary analysis of men and women, estimated mean SUDS scores were 64.7 with VQW-765 and 63.8 with placebo. The 0.9-point difference was not statistically significant (95% confidence interval, -3.00 to 4.73; p=0.6605).

An earlier Phase II study of 230 adults with performance anxiety found a statistically significant result among women (p=0.034), but not across the full study population (p=0.1443). “We are disappointed that Study 3201 did not confirm the earlier Phase II findings for VQW-765 in patients with social anxiety disorder,” Vanda President, CEO and board chairman Mihael H. Polymeropoulos said.

Vanda plans to analyze the full Phase III dataset. The company has not provided a timeline for the review.