Vistagen Achieves Minimum ICH Safety Exposure Recommendations Across Clinical Program for Fasedienol for the Acute Treatment of Social Anxiety Disorder

About this update from Vistagen Therapeutics, Inc.

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced that the Company’s clinical program for fasedienol nasal spray for the acute treatment of social anxiety disorder has achieved the minimum patient exposures as recommended under ICH E1, the international regulatory standard governing safety database exposure recommendations for drugs intended for long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening conditions1. As of May 31, 2026, the Company estimates that the fasedienol clinical development program now exceeds ICH E1 minimum recommendations with over 1,500 subjects receiving at least a single exposure to fasedienol, over 300 subjects with at least 6-months of exposure, and over 100 subjects with at least 12 months of exposure. The 6-month and 12-month exposure numbers represent Vistagen’s estimate of the number of subjects who have completed the 6-month and 12-month visits in the fasedienol open-label safety studies. These exposure estimates are expected to continue to increase to the extent they include subjects currently participating in the ongoing open label extension portion of Vistagen’s PALISADE-3 and PALISADE-4 Phase 3 studies, as well as the randomized and open label portions of its Phase 2 repeat dose study. Although the Company believes the minimum ICH E1 recommendations have been met, Vistagen has not yet aligned with the FDA on the specific patient exposure requirements to support a potential fasedienol NDA submission. “Achieving ICH E1 minimum safety exposure recommendations for fasedienol marks another important milestone in our social anxiety disorder program, and it has been encouraging to see subjects continue to opt into the open label extension portions of our PALISADE-3, PALISADE-4, and repeat dose studies,” said Shawn Singh, President and Chief Executive Officer. “We are encouraged to reach this level of exposure, with fasedienol having been well-tolerated across our completed clinical trials to date.” Topline results from the randomized, double-blind, placebo-controlled portion of PALISADE-4, Vistagen’s Phase 3 clinical trial evaluating fasedienol nasal spray for the acute treatment of social ...

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