Vistagen’s fasedienol is an innovative, rapid-onset investigational pherine nasal spray in Phase 3 clinical development in the U.S. for the acute treatment of anxiety in adults with social anxiety disorder (SAD).

Designed for intranasal administration in low microgram doses, the proposed mechanism of action (MOA) of fasedienol is novel and fundamentally differentiated from all current anti-anxiety medications, including all medications approved by the U.S. Food and Drug Administration (FDA) for the treatment of SAD, as well as all benzodiazepines and other medications prescribed for SAD on an off-label basis.

When administered intranasally, fasedienol activates receptors of peripheral nasal chemosensory neurons that activate subsets of neurons in the olfactory bulbs that, in turn, connect to neurocircuitry in the limbic amygdala involved in the pathophysiology of SAD and potentially other anxiety and mood disorders. Fasedienol is pharmacologically active without requiring apparent systemic distribution or direct activity on neurons in the brain to achieve its rapid-onset and short-duration anxiolytic effects.

In the second half of 2023, Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol in adults with SAD. PALISADE-2 met its primary, secondary, and exploratory efficacy endpoints. During the first half of 2024, Vistagen initiated PALISADE-3 as the next step in its registration-directed PALISADE Phase 3 Program for fasedienol in SAD to complement PALISADE-2. Vistagen plans to initiate PALISADE-4, as well as other potential registration-enabling studies during the second half of 2024.

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