Vistagen Says Fasedienol Nasal Spray Showed Continued Improvement in Social Anxiety Extension Study

Key Points

• Vistagen released early results from a longer-term study of fasedienol nasal spray for people with social anxiety disorder.
• Participants could use the treatment when needed, up to six times a day, for as long as 12 months.
• The company said no new drug-related safety concerns appeared in 322 participants.
• Over four months, participants reported and showed lower levels of social anxiety, fear, and avoidance.
• The earlier placebo-controlled part of the Phase 3 study did not meet its main goal in the overall patient group.

Vistagen (NASDAQ: VTGN) has announced that its experimental fasedienol nasal spray was generally well tolerated and was linked to lower social-anxiety symptoms over time in a follow-up part of its PALISADE-4 Phase 3 study. The new results are early and come from an open-label study, meaning participants and researchers knew they were receiving fasedienol, so they do not prove the treatment caused the improvements.

How the Follow-Up Study Worked

The follow-up study included 322 adults with social anxiety disorder who chose to continue after the main PALISADE-4 trial.

Participants used fasedienol nasal spray before or during stressful social or performance situations in everyday life, such as speaking in front of others or interacting socially. They could use a 3.2-microgram dose up to six times per day for up to 12 months.

Researchers tracked side effects and changes in social-anxiety symptoms. The results released so far cover the first four months of treatment, using data collected through July 24, 2026.

What the Safety Results Showed

Vistagen said fasedienol did not produce new drug-related safety issues during the study period. Five participants—1.6% of the 322 people in the study—stopped participating because of side effects, but the company said none of those cases was linked to fasedienol.

Most side effects were mild or moderate. The most common were headache, upper respiratory infections, runny nose, and throat pain. The company said no serious side effects were judged to be related to fasedienol.

Social Anxiety Scores Improved During the First Four Months

One assessment, called the Liebowitz Social Anxiety Scale, measures how much fear, anxiety, and avoidance people experience in common social and performance situations.

Participants started with an average score of 99.3, which is considered very severe social anxiety. After one month, their scores improved by an average of 20.2 points. By Month 2, the average improvement was 24.6 points; by Month 3, it was 29.1 points; and by Month 4, it reached 31.4 points.

At Month 4, 65% of the 197 participants assessed had improved by at least 20 points on this measure. Vistagen said participants improved in both fear and avoidance, which could mean they felt less anxious and were less likely to avoid difficult social situations.

A second assessment, called the Social Phobia Inventory, asks patients directly about their symptoms. Participants began with an average score of 48.5, a level considered severe social anxiety. Their average score improved by 10.5 points after one month and by 14.9 points after four months. At Month 4, 59% of the 199 assessed participants improved by at least 10 points.

Why the Results Need Caution

These findings are promising but preliminary. The follow-up study did not compare fasedienol with a placebo, and participants chose whether to continue into it. That makes it impossible to know how much of the improvement was due specifically to the nasal spray rather than other factors, including expectations, changes over time, or continued care.

This point is especially important because the earlier randomized part of PALISADE-4 did not meet its main goal across all participants. That portion tested a single dose of fasedienol during a simulated public-speaking challenge and did not show a statistically significant benefit over placebo in the full study group.

Vistagen did report a favorable post-hoc result in a smaller subgroup of 123 people with very severe social anxiety, but that result will need confirmation in future controlled research.

What Happens Next

Vistagen plans to meet with the FDA during the current quarter to discuss a proposed new Phase 3 study of fasedienol for social anxiety disorder.

Fasedienol is still an experimental treatment and is not approved by the FDA. A new controlled trial would be important to determine whether the nasal spray can reliably reduce social-anxiety symptoms and provide a meaningful benefit for patients.