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.

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 social anxiety disorder, as well as all benzodiazepines and other medications prescribed for social anxiety disorder 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 social anxiety disorder 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.

The FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of social anxiety disorder.

For information on clinical trials, please visit clinicaltrials.gov.