Developer · VTGN · United States
Vistagen Therapeutics, Inc.
Vistagen Therapeutics, Inc. is a late clinical-stage biopharmaceutical company developing rapid-onset, neurocircuitry-focused intranasal product candidates called pherines for psychiatric and neurological disorders. Its lead candidate, fasedienol (PH94B) nasal spray, is in Phase 3 development for the acute treatment of social anxiety disorder.
Pipeline (1)
- Social anxiety disorderPhase 3Active
Deals & partnerships
- Fasedienol (PH94B)Licensee AffaMed Therapeutics, Inc.
- Jun 25, 2020Licensing dealVistagen out-licenses fasedienol (PH94B) to EverInsight (now AffaMed) for Greater China, South Korea and Southeast AsiaOn June 25, 2020, VistaGen entered into a strategic licensing and collaboration agreement granting EverInsight Therapeutics an exclusive license to develop, manufacture and commercialize fasedienol (PH94B) nasal spray for social anxiety disorder and potentially other anxiety-related disorders across Greater China (Mainland China, Hong Kong, Macau, Taiwan), South Korea and Southeast Asia (Indonesia, Malaysia, Philippines, Thailand, Vietnam). Terms include a $5 million upfront payment, up to $172 million in development and commercial milestones, plus tiered royalties. EverInsight subsequently became AffaMed Therapeutics, which Vistagen now refers to as its partner for the program; Vistagen retains development and the lead role.
Catalysts · 1 upcoming · 3 reported
- 2Q 2026Anticipated
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-4 topline anticipated 2Q 2026; randomized portion complete.
Recently reported
- 2025-12-17missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-3 missed its primary SUDS endpoint (large placebo response); no secondary difference.
- 2023-08-07met
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-2 met primary SUDS (p=0.015) and key secondary CGI-I (p=0.033) endpoints.
- 2022-06-22missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-1 missed its primary SUDS endpoint; tolerability favorable.
Recent activity
- May 8, 2026Phase changeFasedienol (PH94B)·Social anxiety disorderPhase 3PALISADE-4 (NCT06615557) completed last patient visit of the randomized portion; topline anticipated 2Q 2026 with a refined SAP (FDA had no comments). Program active.source ↗
- Dec 17, 2025ReadoutFasedienol (PH94B)·Social anxiety disordermissedPALISADE-3 missed its primary SUDS endpoint (large placebo response); no secondary difference.source ↗
- Aug 7, 2023ReadoutFasedienol (PH94B)·Social anxiety disordermetPALISADE-2 met primary SUDS (p=0.015) and key secondary CGI-I (p=0.033) endpoints.source ↗
- Jun 22, 2022ReadoutFasedienol (PH94B)·Social anxiety disordermissedPALISADE-1 missed its primary SUDS endpoint; tolerability favorable.source ↗
- May 24, 2021Phase changeFasedienol (PH94B)·Social anxiety disorderPhase 3Vistagen initiated the Phase 3 PALISADE program; PALISADE-1 (NCT04754802) first patient / study start.source ↗
- Feb 28, 2011Phase changeFasedienol (PH94B)·Social anxiety disorderPhase 2Phase 2 proof-of-concept of PH94B in social anxiety disorder (NCT01217788, n=90) completed under originator/early development; supported subsequent development.source ↗
Competitive landscape
Other companies developing against Vistagen Therapeutics, Inc.'s targets or indications.
Leadership & advisors (17)
Former leadership & advisors (2)
- H. Ralph Snodgrass — Co-Founder
- Jerry B. Gin — Independent Director