Vistagen (Nasdaq: VTGN), a late-stage biopharmaceutical company, has launched PALISADE-4, a Phase 3 trial evaluating fasedienol, an investigational nasal spray for the acute treatment of social anxiety disorder (SAD).

This marks a significant milestone in Vistagen's Phase 3 program, which also includes the ongoing PALISADE-3 trial.

Both trials are designed to assess fasedienol's safety and efficacy, with results supporting a potential New Drug Application (NDA) to the FDA.

The double-blind, placebo-controlled trial will randomise 236 adults aged 18-65 nd will focus on acute relief from anxiety triggered by public speaking challenges.

Fasedienol, a neuroactive pherine nasal spray, offers a novel mechanism of action targeting the olfactory-amygdala neural circuits, with no systemic absorption or abuse potential. It is designed to rapidly alleviate symptoms of anxiety, positioning it as a potential first-in-class treatment for SAD, a condition that affects over 30 million Americans. There are currently no FDA-approved acute treatments for SAD, but fasedienol has Fast Track designation for this indication.