Vistagen Therapeutics, Inc. (VTGN)
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical entity dedicated to advancing and commercializing innovative medications for anxiety, depression, and various other disorders impacting the central nervous system (CNS). A key component of its CNS pipeline is PH94B, a fast-acting neuroactive nasal spray currently in Phase III trials for the rapid treatment of anxiety in adults experiencing social anxiety disorder. PH94B also shows potential for addressing a broader spectrum of anxiety conditions, including adjustment disorder with anxiety, postpartum anxiety, post-traumatic stress disorder (PTSD), pre-procedural anxiety, and panic disorders. The company's CNS development initiatives further encompass PH10, another quick-acting neuroactive nasal spray, which is in preparation for Phase 2B clinical assessment as a standalone therapy for major depressive disorder (MDD). Additionally, VistaGen is developing AV-101, an oral N-methyl-D-aspartate receptor antagonist, which is being investigated in conjunction with oral probenecid for its potential application in treating levodopa-induced dyskinesia, MDD, neuropathic pain, and suicidal ideation. VistaGen has established various collaborations, including a contract research and development agreement with Cato Research Ltd., a licensing agreement with Pherin Pharmaceuticals, Inc., and a license and collaboration agreement with EverInsight Therapeutics Inc. Founded in 1998, VistaGen Therapeutics, Inc. is headquartered in South San Francisco, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
VistaGen Therapeutics, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge
PH94B Nasal Spray, Placebo Nasal Spray
Social Anxiety Disorder
NCT04754802Enrollment224StartMay 2021Primary CompletionJun 2022CompletionJun 2022 - Phase 3Terminated
PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge - 2
PH94B Nasal Spray, Placebo Nasal Spray
Social Anxiety Disorder
NCT05011396Enrollment228StartAug 2021Primary CompletionAug 2022CompletionAug 2022 - Phase 3Terminated
Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
PH94B
Social Anxiety Disorder
NCT05030350Enrollment481StartOct 2021Primary CompletionSep 2022CompletionSep 2022 - Phase 3Active, not recruiting
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3)
Fasedienol Nasal Spray, Placebo Nasal Spray
Social Anxiety Disorder
NCT06358651Enrollment238StartMar 2024Primary CompletionOct 2025CompletionOct 2026est. - Phase 3Active, not recruiting
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Fasedienol Nasal Spray, Placebo Nasal Spray
Social Anxiety Disorder (SAD)
NCT06615557Enrollment238StartSep 2024Primary CompletionApr 2026CompletionApr 2027est. - Phase 2Completed
AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
AV-101, Placebo
Major Depressive Disorder
NCT03078322Enrollment180StartMar 2018Primary CompletionOct 2019CompletionOct 2019 - Phase 2Unknown status
AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesia
AV-101, Placebo
Parkinson Disease, Dyskinesia, Medication-Induced +1
NCT04147949Enrollment20StartAug 2022est.Primary CompletionDec 2023est.CompletionApr 2024est. - Phase 2Completed
PH94B in the Treatment of Adjustment Disorder With Anxiety
PH94B, Placebo
Adjustment Disorder With Anxious Mood
NCT04404192Enrollment41StartOct 2021Primary CompletionDec 2022CompletionDec 2022 - Phase 2Recruiting
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
Fasedienol Nasal Spray - Placebo Nasal Spray, Fasedienol Nasal Spray - Fasedienol Nasal Spray
Social Anxiety Disorder
NCT06809179Enrollment60StartJan 2025Primary CompletionApr 2026est.CompletionDec 2026est. - Phase 1Completed
Safety, Tolerability and Pharmacokinetics of Multiple Doses of AV-101 in Healthy Volunteers
AV-101, Placebo
Neuropathic Pain
NCT01483846Enrollment50StartDec 2011Primary CompletionSep 2012CompletionSep 2012 - Phase 1Unknown status
AV-101 Alone and in Combination With Probenecid in Healthy Subjects
AV-101, Probenecid
Drug Drug Interaction
NCT05280054Enrollment24StartDec 2021Primary CompletionSep 2022est.CompletionNov 2022est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | PH94B Nasal Spray, Placebo Nasal Spray | NCT04754802 |
| Phase 3 | Terminated | PH94B Nasal Spray, Placebo Nasal Spray | NCT05011396 |
| Phase 3 | Terminated | PH94B | NCT05030350 |
| Phase 3 | Active, not recruiting | Fasedienol Nasal Spray, Placebo Nasal Spray | NCT06358651 |
| Phase 3 | Active, not recruiting | Fasedienol Nasal Spray, Placebo Nasal Spray | NCT06615557 |
| Phase 2 | Completed | AV-101, Placebo | NCT03078322 |
| Phase 2 | Unknown status | AV-101, Placebo | NCT04147949 |
| Phase 2 | Completed | PH94B, Placebo | NCT04404192 |
| Phase 2 | Recruiting | Fasedienol Nasal Spray - Placebo Nasal Spray, Fasedienol Nasal Spray - Fasedienol Nasal Spray | NCT06809179 |
| Phase 1 | Completed | AV-101, Placebo | NCT01483846 |
| Phase 1 | Unknown status | AV-101, Probenecid | NCT05280054 |