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A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)

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Trial Profile

A US, Phase 3 Multicenter, Randomized, Double-blind, Placebo Controlled Trial of PH94B Nasal Spray for the Acute Treatment of Anxiety Induced by a Public Speaking Challenge in Adult Subjects With Social Anxiety Disorder (PaliSADe-2)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2025

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At a glance

  • Drugs Fasedienol (Primary)
  • Indications Social phobia
  • Focus Registrational; Therapeutic Use
  • Acronyms Palisade-2
  • Sponsors VistaGen Therapeutics

Most Recent Events

  • 07 Aug 2025 According to Vistagen media release, company believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for the acute treatment of social anxiety in adults.
  • 23 May 2025 According to a VistaGen Therapeutics Media Release, data from this study will be presented at the American Society of Clinical Psychopharmacology (ASCP) Conference in Scottsdale, Arizona from May 27-30, 2025.
  • 23 May 2024 According to a VistaGen Therapeutics media release, data from this study will be presented at the American Society of Clinical Psychopharmacology Conference in Miami Beach, Florida from May 28 to 31, 2024.

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