Vistagen Achieves Key Safety Milestone in Fasedienol Clinical Program for Social Anxiety Disorder
Vistagen, a biopharmaceutical company, has announced that its clinical program for fasedienol nasal spray has met the minimum patient exposure recommendations set by the International Council for Harmonisation (ICH) E1 guidelines. These guidelines are crucial for drugs intended for long-term treatment of non-life-threatening conditions. As of May 31, 2026, over 1,500 subjects have received at least one exposure to fasedienol, with more than 300 subjects exposed for at least six months and over 100 subjects for twelve months. This achievement is part of Vistagen's ongoing Phase 3 clinical trials, PALISADE-3 and PALISADE-4, which aim to evaluate the effectiveness of fasedienol for the acute treatment of social anxiety disorder. The company is optimistic about the drug's potential, noting its well-tolerated nature in completed trials. Topline results from the PALISADE-4 trial are expected in the second quarter of 2026, with Phase 2 Repeat Dose study results anticipated in the third quarter. 
