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A randomized, multi-regional, multi-center, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen's PH94B (referred to by AffaMed as AM005) for the acute treatment of anxiety in adults with social anxiety disorder (SAD)

Trial Profile

A randomized, multi-regional, multi-center, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy, safety, and tolerability of VistaGen's PH94B (referred to by AffaMed as AM005) for the acute treatment of anxiety in adults with social anxiety disorder (SAD)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 18 Apr 2022

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At a glance

  • Drugs Fasedienol (Primary)
  • Indications Anxiety; Social phobia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms PALISADE Global
  • Most Recent Events

    • 18 Apr 2022 New trial record
    • 12 Apr 2022 According to VistaGens Therapeutics media release, the company is looking forward to dosing participants in this trial later this year, topline results from this trial is anticipated in mid-2024; Michael Liebowitz, M.D. will serve as the principal investigator.
    • 12 Apr 2022 According to VistaGens Therapeutics media release, PALISADE Global is a study separate from PALISADE-1 and PALISADE-2, which are currently underway and designed to support VistaGens PH94B New Drug Application (NDA) submission to the FDA, should the studies be successful; this trial is designed to support commercialization of PH94B in China and other markets outside the U.S; the companies also anticipate initiating this Phase 3 study in Canada, Mexico, and South Korea.

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