This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve...

Topline results of PALISADE-3 Phase 3 Trial of fasedienol for acute treatment of social anxiety disorder expected in the fourth quarter of 2025 PALISADE-4 Phase 3 Trial topline results expected in the first half of 2026 Vistagen continues to advance diverse intranasal pherine pipeline targeting treatments in psychiatry, women’s health, and cancer supportive care SOUTH …

Reported Thursday, Sep 24 - 7:11am EDT (TheFly subscription required to read more.)

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Key Points Vistagen released early results from a longer-term study of fasedienol nasal spray for people with social anxiety disorder. Participants coul

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Exploratory analyses of patients with very severe social anxiety disorder demonstrated nominally statistically significant improvement in recently reported clinical studies FDA engagement planned during the current quarter regarding potential future Phase 3 path forward for fasedienol in social

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Reported Thursday, Aug 6 - 9:43am EDT (TheFly subscription required to read more.)

Vistagen (Nasdaq: VTGN) reported topline results from an exploratory Phase 2, three‑arm, randomized, double‑blind, placebo‑controlled study (N=61) of intranasal fasedienol for acute treatment of social anxiety disorder induced by a public speaking challenge. The trial compared repeat 3.2 µg dosing ten minutes apart, single 3.2 µg dosing, and placebo.The study met its primary safety objective, with repeat dosing showing safety and tolerability comparable to single dosing and no new safety findings. Numerically greater reductions in subjective units of distress (SUDS) versus placebo were observed for pooled, repeat, and single‑dose fasedienol, though overall group differences were not statistically significant (p=0.2). In a prespecified very severe subgroup (baseline LSAS ≥95), pooled and single‑dose fasedienol showed nominally statistically significant SUDS improvements versus placebo (p=0.04 and p=0.05).Responder rates on CGI‑I and PGI‑C were directionally higher for fasedienol than placebo, with repeat‑dose responder rates more than twice placebo overall and at least four times placebo in the very severe subgroup. A prespecified exploratory analysis of anticipatory anxiety showed larger SUDS reductions for pooled and repeat‑dose fasedienol versus placebo, with nominal statistical significance (p=0.03 and p=0.01). Vistagen indicated these data, together with prior Phase 2 and Phase 3 results, will inform discussions with the FDA about a potential registrational pathway for fasedienol.

The company plans further FDA discussions and a strategic pivot to longer-term treatment.

Vistagen Therapeutics stock crashes after fasedienol, its experimental nasal spray for social anxiety disorder, fails to meet primary endpoints in Phase 3 PALISADE-3 trial.

Vistagen has chalked up another trial failure for fasedienol, its drug candidate for social anxiety disorder.