Vistagen Highlights Fasedienol Potential in Very Severe Social Anxiety Disorder

Key Points

• Vistagen Therapeutics presented exploratory fasedienol data at Psych Congress 2026 in New Orleans.
• The analyses focused on participants with very severe social anxiety disorder, defined by a baseline Liebowitz Social Anxiety Scale score of 95 or higher.
• Fasedienol showed improvements in anxiety symptoms compared with placebo in subgroup analyses from two randomized, double-blind, placebo-controlled clinical trials.
• In the PALISADE-4 Phase 3 study, the very severe subgroup showed a statistically significant benefit, although the overall study did not meet its primary endpoint.
• A Phase 2a repeat-dose study showed a greater numerical improvement after a second dose given 10 minutes after the first.

Vistagen Therapeutics (NASDAQ: VTGN) presented exploratory data at Psych Congress 2026 suggesting that its investigational fasedienol nasal spray may help people with very severe social anxiety disorder. The company said the findings came from analyses of participants with baseline Liebowitz Social Anxiety Scale, or LSAS, scores of 95 or higher in two randomized, double-blind, placebo-controlled clinical trials.

Fasedienol Showed Potential Benefit in Very Severe Social Anxiety Disorder

The data focused on people with very severe social anxiety disorder, which Vistagen defined as an LSAS score of 95 or above at baseline.

In one post-hoc analysis and one prespecified analysis, fasedienol-treated participants with very severe social anxiety showed improvements in anxiety symptoms compared with placebo during a public-speaking challenge. Anxiety was measured using the Subjective Units of Distress Scale, or SUDS.

The results support the company’s view that fasedienol may have potential in a subgroup of patients with especially severe social anxiety symptoms.

PALISADE-4 Phase 3 Subgroup Analysis Found Statistically Significant Results

In the randomized, placebo-controlled part of Vistagen’s PALISADE-4 Phase 3 study, the company reported that fasedienol produced a statistically significant benefit on average SUDS scores during the public-speaking challenge among participants with very severe social anxiety disorder.

However, PALISADE-4 did not meet its primary endpoint in the overall study population. The reported Phase 3 finding in the very severe subgroup was a post-hoc analysis, meaning it was conducted after the data were collected.

Repeat-Dose Phase 2a Study Showed Further Numerical Improvement

Vistagen also presented data from an exploratory Phase 2a repeat-dose study. In a prespecified analysis of participants with very severe social anxiety disorder, a single fasedienol dose produced a statistically significant improvement in average SUDS scores during the public-speaking challenge.

The company said a second intranasal fasedienol dose, administered 10 minutes after the first, led to an even greater numerical improvement in average SUDS scores.

The study also found significant improvement in anxiety before the public-speaking challenge, known as anticipatory anxiety, in both the overall trial population and the very severe social anxiety subgroup. Vistagen said the results suggest a second dose may further improve anticipatory anxiety.

Fasedienol Safety Results Were Consistent With Prior Studies

Vistagen said fasedienol’s safety and tolerability in people with very severe social anxiety disorder were consistent with results observed in the overall populations of the two trials and in previous fasedienol studies.

The company reported no serious drug-related safety signals in the very severe social anxiety participants included in the poster presentation.

Fasedienol remains an investigational, rapid-onset nasal spray candidate. Vistagen said the results provide insights into its potential role in treating very severe social anxiety disorder, but further clinical evaluation will be needed.