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All planned clinical studies in fasedienol U.S. registration-directed Phase 3 program for the acute treatment of social anxiety disorder are underway
Vistagen (NASDAQ:VTGN), a late clinical-stage company dedicated to pioneering neuroscience based on nose-to-brain neurocircuitry, today announced enrollment of the first subject in a repeat dose study of fasedienol, its investigational neuroactive pherine nasal spray in Phase 3 development for the acute treatment of social anxiety disorder (SAD).
The repeat dose study is a small exploratory U.S. Phase 2 multi-center, randomized, double-blind, placebo-controlled, three-arm clinical trial designed to assess the efficacy, safety, and tolerability of a repeat dose of fasedienol (3.2 micrograms) in adults with SAD during a public speaking challenge conducted in a clinical setting. The three dosing arms will be fasedienol followed by fasedienol (total 6.4 micrograms), fasedienol followed by placebo (total 3.2 micrograms), and placebo followed by placebo, with the second dose in each arm administered ten minutes after the initial dose. Other than the repeat dose and the additional study arm, the study is similar in design to the ongoing PALISADE Phase 3 studies for the acute treatment of adults with SAD, including an open-label extension.
Posted In: VTGN
