Developer · VTGN · United States
Vistagen Therapeutics, Inc.
Clinical-stage biopharmaceutical company (Nasdaq: VTGN) headquartered in South San Francisco, CA. Its neuroscience pipeline consists of five clinical-stage intranasal pherine candidates (including fasedienol and itruvone) plus the oral NMDA-receptor glycine-site prodrug AV-101, which it no longer plans to develop on its own.
Phase distribution
Modality
- Small molecule 2
Mechanism focus
Pipeline (2)
- Social anxiety disorderPhase 3Active
- Levodopa-induced dyskinesia in Parkinson's diseasePhase 1Suspended
- Neuropathic painPhase 1Suspended
- Major depressive disorderDiscontinuedDiscontinued
Deals & partnerships
- Fasedienol (PH94B)Licensee AffaMed Therapeutics, Inc.
- Mar 5, 2026Workforce reduction / restructuringVistagen cuts ~20% of workforce to prioritize the fasedienol PALISADE programBoard-approved reduction in force of approximately 20% to preserve cash while prioritizing fasedienol PALISADE development; cash runway guided into 2027.
- 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 · 8 reported
- Q3 2026Anticipated
Fasedienol (PH94B)forSocial anxiety disorderRegulatory
FDA meeting on potential future Phase 3 registrational pathway for fasedienol in social anxiety disorder expected during Q3 2026
Recently reported
- 2026-08-06mixed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
Phase 2 repeat-dose study topline: safety objective met for two-dose regimen; efficacy numerically separated from placebo but not statistically significant (exploratory)
- 2026-06-30missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-4 Phase 3 topline: fasedienol missed primary and secondary endpoints in social anxiety disorder public speaking challenge
- 2026-05-12met
Fasedienol (PH94B)forSocial anxiety disorderInterim analysis
PALISADE-3 open-label extension preliminary data: fasedienol well-tolerated over up to 12 months of as-needed use; clinically relevant improvement on LSAS and SPIN over four months
- 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.
- 2020-03-31missed
AV-101 (L-4-chlorokynurenine)forMajor depressive disorderFull results
NIMH crossover trial in treatment-resistant depression (n=19): 4-Cl-KYN 1080-1440 mg/day for 14 days had no antidepressant effect on HAM-D versus placebo (treatment-by-time P=.16); CSF 7-Cl-KYNA mostly below detection.
- 2019-11-14missed
AV-101 (L-4-chlorokynurenine)forMajor depressive disorderTopline data
ELEVATE Phase 2 (adjunctive AV-101 1440 mg/day in MDD, n=199): AV-101 did not differentiate from placebo on change from baseline in MADRS-10; well tolerated, no psychotomimetic effects or SAEs.
Recent activity
- Aug 6, 2026ReadoutFasedienol (PH94B)·Social anxiety disordermixedPhase 2 repeat-dose study topline: safety objective met for two-dose regimen; efficacy numerically separated from placebo but not statistically significant (exploratory)source ↗
- Jun 30, 2026ReadoutFasedienol (PH94B)·Social anxiety disordermissedPALISADE-4 Phase 3 topline: fasedienol missed primary and secondary endpoints in social anxiety disorder public speaking challengesource ↗
- Jun 15, 2026Phase changeAV-101 (L-4-chlorokynurenine)·Levodopa-induced dyskinesia in Parkinson's diseasePhase 1Vistagen's FY2026 10-K: 'We do not anticipate further development and commercialization of AV-101 on our own', while assessing a path forward with a third party for LID, neuropathic pain or other NMDAR-related disorders. The date is the filing date (an upper bound); the FY2023 10-K (2023-06-28) still said the company was 'preparing for Phase 2A development of AV-101, on our own or with collaborators'.source ↗
- Jun 15, 2026Phase changeAV-101 (L-4-chlorokynurenine)·Neuropathic painPhase 1Vistagen's FY2026 10-K: no further development of AV-101 on its own; assessing a third-party path for LID, neuropathic pain or other NMDAR-related disorders. Filing date used as an upper bound.source ↗
- May 12, 2026ReadoutFasedienol (PH94B)·Social anxiety disordermetPALISADE-3 open-label extension preliminary data: fasedienol well-tolerated over up to 12 months of as-needed use; clinically relevant improvement on LSAS and SPIN over four monthssource ↗
- 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 28, 2023Phase changeAV-101 (L-4-chlorokynurenine)·Major depressive disorderDiscontinuedINFERRED, not announced. The FY2022 10-K (2022-06-23) still listed AV-101 plus probenecid as a potential MDD treatment. The FY2023 10-K (2023-06-28) shifted to 'Phase 2A development ... as a treatment for one or more neurological disorders', and the FY2026 10-K names only LID and neuropathic pain and says no further development on its own. Vistagen has made no explicit discontinuation statement for MDD; the date is the first filing reflecting the pivot.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 ↗
- Mar 31, 2020ReadoutAV-101 (L-4-chlorokynurenine)·Major depressive disordermissedNIMH crossover trial in treatment-resistant depression (n=19): 4-Cl-KYN 1080-1440 mg/day for 14 days had no antidepressant effect on HAM-D versus placebo (treatment-by-time P=.16); CSF 7-Cl-KYNA mostly below detection.source ↗
Competitive landscape
Other companies developing against Vistagen Therapeutics, Inc.'s targets or indications.
- Axsome Therapeutics, Inc.2 compoundsNMDA receptorMajor depressive disorder
- Gilgamesh Pharmaceuticals, Inc.2 compoundsNMDA receptorMajor depressive disorder
- Vanda Pharmaceuticals Inc.2 compoundsMajor depressive disorderSocial anxiety disorder
- ABVC BioPharma, Inc.1 compoundMajor depressive disorder
- Alto Neuroscience, Inc.2 compoundsMajor depressive disorder
- Apurano Pharmaceuticals GmbH1 compoundNeuropathic pain
- Autobahn Therapeutics, Inc.1 compoundMajor depressive disorder
- Avanir Pharmaceuticals1 compoundNMDA receptor
- Beckley Psytech Limited1 compoundMajor depressive disorder
- Biohaven Ltd.1 compoundMajor depressive disorder
- Boehringer Ingelheim2 compoundsMajor depressive disorder
- Cerevel Therapeutics1 compoundMajor depressive disorder
Leadership & advisors (17)
Former leadership & advisors (2)
- H. Ralph Snodgrass — Co-Founder
- Jerry B. Gin — Independent Director