VistaGen Therapeutics (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company developing new generation medicines for multiple CNS diseases and disorders with high unmet need. Our pipeline includes three clinical-stage CNS drug candidates, PH94B, PH10, and AV-101, each with a differentiated mechanism of action, an exceptional safety profile in all clinical studies to date, and therapeutic potential in multiple CNS markets.
• PH94B is an investigational first-in-class, odorless, fast-acting synthetic neurosteroid initially being developed as a potential fast-acting, non-sedating, non-addictive new generation treatment of social anxiety disorder (SAD). We are is now preparing for Phase 3 clinical development of PH94B for SAD and the FDA has granted Fast Track designation for development of PH94B for treatment of SAD, the FDA's first ever Fast Track designation for development of a drug candidate for treatment of SAD.
• PH10 is an investigational first-in-class, odorless, fast-acting synthetic neurosteroid initially being developed as a potential fast-acting, non-sedating, non-addictive new generation treatment of major depressive disorder (MDD) that can be conveniently self-administered at home. Following successfully completed Phase 2a development for MDD, we are now preparing for planned Phase 2b clinical development of PH10 for MDD.
• AV-101 (4-Cl-KYN) is an oral prodrug of 7-Cl-KYNA, which is a potent and selective NMDAR glycine site antagonist. Following positive preclinical efficacy studies of AV101 in multiple CNS indications, as well as recent positive preclinical studies of AV-101 in combination with probenecid, VistaGen is conducting additional AV-101 preclinical studies and assessing opportunities for potential Phase 2a clinical development of AV-101. The FDA has granted Fast Track designation for development of AV-101 as both a potential adjunctive treatment for MDD and as a non-opioid treatment for neuropathic pain.