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News
A promising on-demand treatment for social anxiety disorder hits a wall. Vanda Pharmaceuticals' VQW-765 failed to outperform placebo in a phase 3 trial of 546 adults, missing both primary and secondary endpoints. The clinical program is now on hold while the company reviews the data.
Vanda Pharmaceuticals' investigational drug VQW-765 — an oral alpha-7 nicotinic acetylcholine receptor partial agonist designed for on-demand use — has failed in its pivotal phase 3 trial for social anxiety disorder (SAD). The study enrolled 546 adults aged 18–65 with confirmed SAD diagnoses, randomizing them to a single dose of VQW-765 or placebo before undergoing the Trier Social Stress Test (TSST), a standardized public-speaking challenge designed to induce acute stress.
The results were a clear disappointment: distress scores during the performance phase were virtually identical between the VQW-765 and placebo groups, with no statistically significant difference in either female participants (the primary endpoint) or the overall study population. The drug's safety profile remained consistent with earlier studies, but that wasn't enough to salvage the program — Vanda has placed the VQW-765 clinical program on hold pending further data review.
By the Numbers
Why it matters: SAD affects millions of people worldwide, and effective on-demand treatment options remain limited. This failure underscores the persistent challenge of translating phase 2 signals into phase 3 success in psychiatric drug development — a hurdle that continues to slow progress in the field.
