VistaGen Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel medicines for the treatment of disorders involving the central nervous system (CNS). The Company’s lead product candidate, AV-101, is a next generation depression therapy with strong safety and an emerging efficacy profile addressing significant shortcomings of standard therapies. AV-101 is an orally-available NMDA receptor (NMDAR) glycine-binding (GlyB) site antagonist that has been shown to provide ketamine-like antidepressant effects without the undesired side effects.
AV-101 is currently being evaluated in an NIH-sponsored Phase 2a study for treatment-resistant major depressive disorder (MDD), with results expected in the second quarter of 2017. VistaGen is also planning to initiate a Phase 2b study of AV-101 for the treatment of MDD in the fourth quarter of 2016. Based on preclinical studies, AV-101 also has the potential to address multiple neuropsychiatric, neurological and neurodegenerative diseases, including bipolar disorder, chronic neuropathic pain, epilepsy, Huntington’s disease and Parkinson’s disease.