Vistagen Presents Fasedienol Subgroup Data in Severe Social Anxiety Disorder

Vistagen (NASDAQ:VTGN) presented exploratory clinical data for its investigational fasedienol nasal spray at Psych Congress 2026 in New Orleans on September 24, reporting findings from subgroup analyses involving participants with very severe social anxiety disorder.

The findings were derived from two randomised, double-blind, placebo-controlled clinical trials and included one post-hoc analysis and one prespecified subgroup analysis.

Participants included in the very severe subgroup had baseline Liebowitz Social Anxiety Scale scores of 95 or higher.

The subgroup findings are exploratory and should be distinguished from results in the overall trial populations. Fasedienol remains an investigational Phase 3 product candidate and has not received regulatory approval.

PALISADE-4 Subgroup Shows Difference on Distress Scale

In a post-hoc analysis of the Phase 3 PALISADE-4 trial, fasedienol showed a statistically significant difference compared with placebo in average Subjective Units of Distress Scale scores during a public-speaking challenge among participants in the very severe subgroup.

However, PALISADE-4 did not meet its primary endpoint in the overall study population.

Because the subgroup analysis was conducted post hoc, its findings are exploratory and do not change the outcome of the trial’s primary endpoint.

Phase 2a Analysis Examines Repeat Dosing

Vistagen also reported results from a separate exploratory Phase 2a repeat-dose study.

A prespecified analysis of participants in the very severe subgroup showed a statistically significant improvement following a single dose of fasedienol compared with placebo. A second dose administered 10 minutes after the first was associated with a greater numerical improvement, according to the company.

The study also showed statistically significant improvements in anticipatory anxiety in both the overall study population and the very severe subgroup.

“These findings, including the potential benefit of repeat dosing, help inform our ongoing evaluation of fasedienol,” said Dr. Angel S. Angelov, Chief Medical Officer of Vistagen.

The comments reflect the company’s interpretation of the exploratory findings and do not establish the efficacy of repeat dosing.

Vistagen Reports No Serious Drug-Related Safety Signals

Vistagen said no serious drug-related safety signals were identified in the analyses.

According to the company, safety and tolerability findings in participants with very severe social anxiety disorder were consistent with those observed in the overall study populations and previous trials.

The findings were disclosed in a company press release. Fasedienol remains in Phase 3 clinical development, and the reported exploratory and subgroup results do not establish that the candidate will receive regulatory approval.

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