COMPANY

Vistagen Therapeutics

Profile checked Oct 10, 2026

Keywords: Social Anxiety Disorder epilepsy Adjustment Disorder With Anxious Mood Drug Drug Interaction Parkinson Disease Medication-Induced Dyskinesia L-Dopa Causing Adverse Effects in Therapeutic Use Major Depressive Disorder Neuropathic Pain AV-101 PH94B

11Trials (company is sponsor)14NIH grants

Timeline

Jan 9, 2025 Trial start Phase 2: A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder source ↗
Sep 16, 2024 Trial start Phase 3: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4) source ↗
Mar 28, 2024 Trial start Phase 3: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3) source ↗
2022-08 Trial start Phase 2: AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia source ↗
Dec 23, 2021 Trial start Phase 1: AV-101 Alone and in Combination With Probenecid in Healthy Subjects source ↗
Oct 12, 2021 Trial start Phase 2: PH94B in the Treatment of Adjustment Disorder With Anxiety source ↗
Oct 1, 2021 Trial start Phase 3: Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD) source ↗
Aug 30, 2021 Trial start Phase 3: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2 source ↗
May 24, 2021 Trial start Phase 3: PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge source ↗
Mar 5, 2018 Trial start Phase 2: AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression source ↗
2011-12 Trial start Phase 1: Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers source ↗

Clinical trials (lead sponsor) 11

Record	Title	Phase	Status	Start	Primary completion
NCT06615557	Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)	Phase 3	Active, not recruiting	Sep 16, 2024	Apr 21, 2026 (actual)
NCT06809179	A Clinical Trial to Assess the Efficacy, Safety, and Tolerability of a Repeat Dose of Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder	Phase 2	Recruiting	Jan 9, 2025	2026-04 (estimated)
NCT04404192	PH94B in the Treatment of Adjustment Disorder With Anxiety	Phase 2	Completed	Oct 12, 2021	Dec 14, 2022 (actual)
NCT06358651	Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)	Phase 3	Active, not recruiting	Mar 28, 2024	Oct 31, 2025 (actual)
NCT05011396	PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2	Phase 3	Terminated	Aug 30, 2021	Aug 16, 2022 (actual)
NCT05030350	Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)	Phase 3	Terminated	Oct 1, 2021	Sep 23, 2022 (actual)
NCT04754802	PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge	Phase 3	Completed	May 24, 2021	Jun 22, 2022 (actual)
NCT05280054	AV-101 Alone and in Combination With Probenecid in Healthy Subjects	Phase 1	Unknown status (ClinicalTrials.gov)	Dec 23, 2021	Sep 1, 2022 (estimated)
NCT04147949	AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia	Phase 2	Unknown status (ClinicalTrials.gov)	2022-08	2023-12 (estimated)
NCT03078322	AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression	Phase 2	Completed	Mar 5, 2018	Oct 1, 2019 (actual)
NCT01483846	Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers	Phase 1	Completed	2011-12	2012-09 (actual)

NIH awards 14

Annual award amounts. Total $11.2M.

Jul 19, 2010 NIH award 3R44DA018515-03S1 FY2010: $419,898 awarded for that fiscal year; activity R44 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Clinical Development of source ↗
Jun 25, 2010 NIH award 5R44DA018515-03 FY2010: $1,714,903 awarded for that fiscal year; activity R44 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Clinical Development of source ↗
Jun 22, 2009 NIH award 2R44DA018515-02 FY2009: $2,469,281 awarded for that fiscal year; activity R44 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Clinical Development of source ↗
Sep 28, 2007 NIH award 5U01NS048214-03 FY2007: $1,196,369 awarded for that fiscal year; activity U01 (OTHER_NIH); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Preclinical Develo source ↗
Sep 29, 2006 NIH award 5U01NS048214-02 FY2006: $1,194,505 awarded for that fiscal year; activity U01 (OTHER_NIH); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Preclinical Develo source ↗
Jul 1, 2005 NIH award 1R43DA018515-01A1 FY2005: $196,894 awarded for that fiscal year; activity R43 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Preclinical Development source ↗
May 23, 2005 NIH award 1U01NS048214-01A1 FY2005: $1,229,375 awarded for that fiscal year; activity U01 (OTHER_NIH); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Preclinical Deve source ↗
Jul 12, 2004 NIH award 3R43NS047808-01S1 FY2004: $38,000 awarded for that fiscal year; activity R43 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Development of 4-Chlorok source ↗
Jan 12, 2004 NIH award 1R43NS047808-01 FY2004: $380,752 awarded for that fiscal year; activity R43 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Development of 4-Chloroky source ↗
Jun 23, 2003 NIH award 5R44GM061468-03 FY2003: $742,682 awarded for that fiscal year; activity R44 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. DEVELOPMET OF STEM CELL T source ↗
Sep 12, 2002 NIH award 1R43CA094793-01 FY2002: $185,478 awarded for that fiscal year; activity R43 (SBIR); PI MICHELSON, SETH G; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. Multivariate Analysis fo source ↗
Sep 2, 2002 NIH award 2R44GM061468-02A1 FY2002: $948,465 awarded for that fiscal year; activity R44 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. DEVELOPMET OF STEM CELL source ↗
Mar 29, 2001 NIH award 1R43CA091665-01 FY2001: $219,757 awarded for that fiscal year; activity R43 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. IN VITRO STEM CELL ASSAY source ↗
Apr 30, 2000 NIH award 1R43GM061468-01 FY2000: $249,754 awarded for that fiscal year; activity R43 (SBIR); PI SNODGRASS, RALPH; recipient as written: VISTAGEN THERAPEUTICS, INC., SOUTH SAN FRANCISCO, CA. STEM CELL TECHNOLOGIES FO source ↗