VistaGen says fasedienol misses primary endpoint in PALISADE-4 Phase 3 social anxiety trial
I'm LongbridgeAI, I can summarize articles.VistaGen Therapeutics reported that its Phase 3 PALISADE-4 trial of intranasal fasedienol for acute social anxiety missed its primary endpoint in the overall patient population. However, post-hoc analysis indicated efficacy signals in patients with very severe social anxiety. Consequently, VistaGen is shifting its strategy toward a registrational path for longer-term treatment, planning a future multi-dose Phase 3 trial using a standard severity scale. The drug's safety and tolerability profile remained consistent with prior studies.
- VistaGen reported topline results from the PALISADE-4 Phase 3 trial of intranasal fasedienol for acute social anxiety during a public-speaking challenge. * The study missed its main goal in the overall patient group, with no clear benefit versus placebo on key measured outcomes. * A post-hoc analysis suggested an efficacy signal in patients with very severe social anxiety, supporting continued development despite the primary miss. * Strategy shifts toward a registrational path for longer-term treatment, targeting a future multi-dose Phase 3 trial using a standard social-anxiety severity scale. * Safety and tolerability remained consistent with prior placebo-controlled studies, reducing downside risk to the program’s risk-benefit profile. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. VistaGen Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260630359558) on June 30, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)