Vistagen reports Phase 2 repeat dose results for fasedienol in social anxiety disorder

Vistagen announced on August 6, 2026 topline results from an exploratory Phase 2 repeat dose study of its intranasal candidate fasedienol in adults with social anxiety disorder. The three-arm, randomized, double-blind, placebo-controlled trial enrolled 61 subjects and compared two 3.2 µg doses given ten minutes apart against a single 3.2 µg dose and placebo, in the context of a public speaking challenge.¹

The company noted upfront that the study was not designed to demonstrate statistically significant differences between treatment groups.¹ On the primary endpoint, measuring change in subjective units of distress from baseline to the randomized speech, both active treatment arms showed numerical separation from placebo, though the differences were not statistically significant (p=0.2).¹

In a prespecified subgroup of patients with very severe social anxiety disorder, defined by a baseline LSAS score of 95 or higher, fasedienol showed nominally statistically significant responses for the single dose arm compared with placebo and as pooled, with the pooled group at p=0.04 and the single dose arm at p=0.05.¹ The company said these findings are consistent with results previously observed in a post-hoc analysis of the Phase 3 PALISADE-4 trial, where the same very severe subgroup showed a nominally significant improvement versus placebo (p=0.036).¹

On safety, the repeat dose produced safety and tolerability data comparable to single-dose administration, with no new safety findings.¹ Vistagen said the data will help inform discussions with the FDA regarding a potential registrational pathway for fasedienol.¹