Vistagen Therapeutics, Inc. is a late clinical-stage biopharmaceutical company, which engages in developing and commercializing medication and treatment for anxiety, depression, and other central nervous system disorders. Its product portfolio includes Fasedienol (PH94B) nasal spray for social anxiety disorder, Itruvone (PH10) nasal spray for depression disorders, AV-101 oral NMDR glycine site antagonist for depression and neurological disorders, PH15 acute treatment for improvement of cognition, PH80 acute management of vasomotor symptoms due to menopause, and PH284 acute management of Wasting syndrome (Cachexia). The company was founded by H. Ralph Snodgrass and Gordon Keller on May 26, 1998 and is headquartered in South San Francisco, CA.
Clinical Trials
11
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1998
Active, not recruiting
2
18.2%
Completed
4
36.4%
Recruiting
1
9.1%
Terminated
2
18.2%
Unknown
2
18.2%
No approval data available
- A comprehensive pipeline report reveals over 75 companies are developing innovative treatments for major depressive disorder, with several promising candidates advancing through Phase III trials. - Key emerging therapies include SAGE Therapeutics' SAGE-217 oral neuroactive steroid, Relmada Therapeutics' REL-1017 NMDAR channel blocker, and COMPASS Pathways' psilocybin-based COMP360. - The MDD therapeutics market was valued at $7.2 billion in 2023 across seven major markets, with significant growth expected through 2034 driven by novel mechanisms of action. - Several candidates have received FDA Fast Track designation, including REL-1017 and VistaGen's PH10 nasal spray, highlighting regulatory support for innovative depression treatments.
- VistaGen Therapeutics is progressing with Phase 3 clinical trials for fasedienol, a drug candidate for Social Anxiety Disorder (SAD). - Stifel reiterated a Buy rating on VistaGen's stock, citing the potential success of the PAL-3 and PAL-4 trials. - VistaGen is also advancing itruvone into Phase 2b trials and preparing for a U.S. IND submission for PH80 for menopausal hot flashes. - The company's shares are trading near cash value, presenting a favorable risk/reward balance according to Stifel.
- VistaGen's Phase 3 trials for fasedienol in acute social anxiety disorder are progressing, with PALISADE-4 active and results expected from PALISADE-3 and PALISADE-4 in 2025. - The Phase 2 PALISADE-2 trial demonstrated significant positive results, supporting the ongoing Phase 3 studies for fasedienol in treating social anxiety disorder. - VistaGen is also advancing itruvone for major depressive disorder, with a Phase 2b study planned after encouraging Phase 2a results, expanding its pipeline. - With a cash reserve of $97.6 million, VistaGen is financially stable through fiscal year 2026, supporting its clinical development programs.
