VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company committed to developing and commercializing new generation medications that go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders. Our CNS portfolio includes three differentiated drug candidates, PH94B, PH10 and AV-101, each with a novel mechanism of action, an exceptional safety profile in all studies to date, and therapeutic potential for multiple indications.
PH94B Neuroactive Nasal Spray
PH94B is a non-systemic, rapid-onset (approximately 15 minutes) neuroactive nasal spray with potential to treat multiple anxiety disorders without the side effects and safety concerns associated with benzodiazepines. Following a highly statistically significant (p=0.002) Phase 2 study of PH94B in adults with social anxiety disorder (SAD) and a successful meeting with the U.S. Food and Drug Administration (FDA), we are currently preparing for pivotal Phase 3 development of PH94B for the acute treatment of anxiety in adults with SAD.
PH10 Neuroactive Nasal Spray
PH10 is a non-systemic, rapid-onset neuroactive nasal spray with potential to treat multiple depression disorders, without the side effects and safety concerns associated with current medications for depression, such as SSRIs, SNRIs, atypical anti-psychotics and ketamine-based therapy. VistaGen is preparing for planned Phase 2B clinical development of PH10 as a new generation stand-alone treatment for major depressive disorder (MDD).
AV-101, an Oral NMDAR Glycine Site Antagonist
AV-101 targets the NMDAR (N-methyl-D-aspartate receptor). Abnormal NMDAR function is associated with numerous CNS disorders. AV-101 is an oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), a potent and selective full antagonist of the glycine co-agonist site of the NMDAR that inhibits the function of the NMDAR. With its exceptional side effects and safety profile in all clinical studies to date, AV-101, in combination with probenecid, has potential to be an oral new generation treatment for multiple CNS indications. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for major depressive disorder and as a non-opioid treatment for neuropathic pain.