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Vistagen Announces Completion of Last Patient Visit in PALISADE-4 Phase 3 Public Speaking Challenge Study of Fasedienol for Acute Treatment of Social Anxiety Disorder

VTGN
  • Vistagen (NASDAQ: VTGN) announced the last patient completed the randomized portion of its Phase 3 PALISADE-4 trial for fasedienol nasal spray in acute social anxiety disorder.
  • Topline results for the randomized portion of PALISADE-4 are expected in the second quarter of 2026.
  • The open-label extension (OLE) portion of the PALISADE-4 study remains ongoing, allowing participants to use fasedienol up to six times daily for twelve months.
  • PALISADE-4 is a U.S. multi-center, randomized, double-blind, placebo-controlled study using the Subjective Units of Distress Scale (SUDS) as the primary endpoint to evaluate a single dose's efficacy.
  • Vistagen refined the statistical analysis plan (SAP) for PALISADE-4 to include pre-dosing distress levels (pre-IP SUDS) based on analyses of previous PALISADE-1, 2, & 3 datasets.
  • The FDA has reviewed the refined SAP, provided no comments on the changes, and confirmed no protocol changes were made.
  • Fasedienol has Fast Track designation from the FDA for the acute treatment of social anxiety disorder.
  • Successful results from PALISADE-4, combined with PALISADE-2 data, could support a future New Drug Application (NDA) submission.
  • Fasedienol is a "pherine" candidate designed to modulate nasal-limbic amygdala circuits without requiring systemic absorption or brain uptake to achieve rapid anxiolytic effects.
  • The drug exhibits no observed binding to dopamine or opiate receptors associated with abuse liability and does not potentiate GABA-A receptors like benzodiazepines.
  • Vistagen is a late clinical-stage company with a pipeline of five pherine candidates targeting social anxiety disorder, major depressive disorder, and menopausal vasomotor symptoms.