Clinical TrialAug 6, 2026, 08:35 AM
Vistagen's Fasedienol Phase 2 Shows Efficacy Signals in Social Anxiety
AI Summary
Vistagen announced positive topline results from its exploratory Phase 2 repeat dose study of fasedienol nasal spray for social anxiety disorder. The study demonstrated favorable safety and tolerability, with efficacy signals observed across primary and secondary endpoints. Notably, a prespecified analysis of patients with very severe social anxiety disorder showed nominally statistically significant improvement. These results will inform discussions with the FDA regarding a potential registrational pathway for fasedienol.
Key Highlights
- Fasedienol repeat dose showed favorable safety and tolerability, similar to single dose.
- Efficacy signals observed across primary and secondary endpoints in both repeat and single dose.
- Prespecified analysis of very severe social anxiety disorder patients showed nominally significant improvement.
- Pooled fasedienol (N=24) in very severe SAD showed -16.2 SUDS change (p=0.04).
- Repeat dose fasedienol (N=10) in very severe SAD showed -17.5 SUDS change (p=0.08).
- CGI-I responder rates were 40% for pooled fasedienol vs. 19% for placebo.
- PGI-C responder rates were 33% for pooled fasedienol vs. 19% for placebo.
- Repeat dose fasedienol showed nominally significant reduction in anticipatory anxiety (p=0.01).
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