VistaGen gets FDA feedback on Phase 3 path for fasedienol in social anxiety disorder

Vistagen announced on November 9, 2026 that it had held a Type C meeting with the U.S. Food and Drug Administration to go over possible registrational paths for developing fasedienol, its lead product candidate, in social anxiety disorder.¹

The FDA weighed in on the company's plan to use the Liebowitz Social Anxiety Scale as the main endpoint in a planned Phase 3 trial. The agency's feedback touched on interim assessments meant to show whether fasedienol's acute effects translate into longer-term functional improvement, in line with the drug's proposed mechanism and treatment rationale.¹ In response, Vistagen plans to add interim assessments using eDiaries and qualitative patient surveys to the future Phase 3 design and to submit a revised protocol to the FDA.¹

CEO Shawn Singh called the feedback important, saying receiving the FDA's feedback is an important milestone for the company's continued Phase 3 development of fasedienol, and that it provides direction as the company refines its registration-directed study design and development plan.¹

The FDA also addressed the drug's safety and reach. The agency acknowledged fasedienol's reported safety profile and its potential to benefit a broad population of patients with SAD.¹ Based on that input, Vistagen now plans to focus further development on the general SAD population and to pursue fasedienol for overall, rather than strictly acute, treatment of SAD.¹

Vistagen describes itself as developing a category of nasal treatments it calls "pherines," designed to work without being absorbed into the bloodstream or taken up by the brain, which the company says could make them a safer option than other drug approaches if development and approval succeed.¹ Its most advanced candidates include fasedienol, along with itruvone for major depressive disorder and refisolone for menopause-related hot flashes, according to the filing.