Vistagen Therapeutics said its fasedienol nasal spray didn't achieve its primary endpoint in a trial for the acute treatment of social anxiety disorder.
The company said Tuesday there was no treatment difference between fasedienol and placebo for the secondary endpoints.
Favorable safety and tolerability data of fasedienol were consistent with previous placebo-controlled clinical trials, Vistagen said.
In a post-hoc analysis, fasedienol achieved a nominal statistically significant improvement on primary endpoint in patients with very severe social anxiety disorder, the company said.
Based on the totality of data to date from the fasedienol development program in social anxiety disorder, Vistagen said it believes there is evidence of the nasal spray's therapeutic potential for patients with social anxiety disorder.
The company said it plans to transition from the acute treatment of social anxiety disorder symptoms to a potential registrational pathway focused on the overall treatment of social anxiety disorder over time.
As a result, the company said it will meet with the Food and Drug Administration to discuss a registrational pathway for fasedienol involving a single future Phase 3 trial with the Liebowitz Social Anxiety Scale as the primary endpoint.
Write to Freddy Sebastian at freddy.sebastian@wsj.com
(END) Dow Jones Newswires
June 30, 2026 08:28 ET (12:28 GMT)
Copyright (c) 2026 Dow Jones & Company, Inc.
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