VistaGen's lead candidate, PH94B, is a nasally-administered spray currently in multiple Phase 3 trials in the U.S., with topline results anticipated in 2022. Should ongoing Phase 3 studies be successful, PH94B has the potential to be the first FDA-approved, fast-acting, acute treatment of anxiety for adults with social anxiety disorder..
VistaGen's lead candidate, PH94B, is a nasally administered spray currently in multiple Phase 3 trials in the U.S., with topline results anticipated in 2022. Should ongoing Phase 3 studies be. VistaGen currently has three innovative CNS drug candidates in its pipeline: PH94B, PH10 and AV-101. With a differentiated mechanism of action and an exceptional safety profile in all clinical studies to date, each of VistaGen's three drug candidates offers significant commercialization potential in multiple large CNS markets. Status: VistaGen said May 18 it submitted its proposed protocol for a Phase IIA study of PH94B to the FDA through its new Coronavirus Treatment Acceleration Program (CTAP). The proposed Phase II. VistaGen's lead candidate, PH94B, is a nasally-administered spray currently in multiple Phase 3 trials in the U.S., with topline results anticipated in 2022. Should ongoing Phase 3 studies be. SOUTH SAN FRANCISCO, June 02, 2022--VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen), a late clinical-stage, central nervous system (CNS)-focused biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders, today announced that the clinical trial abstract for its exploratory Phase 2A clinical study in. VistaGen's lead asset, PH94B, is currently in multiple Phase 3 trials and has the potential to be the first FDA-approved, fast-acting, acute treatment of anxiety for adults with social anxiety. PH94B is entering Phase 3 development for social anxiety disorder and received Fast Track designation for that indication in December 2019. VistaGen licensed the nasal spray from Pherin Pharmaceuticals in 2018. VistaGen CEO Shawn Singh commented, “The recent onset of mental health stressors associated with the COVID-19 pandemic is.
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(RTTNews) - VistaGen Therapeutics Inc. (VTGN) said that its PALISADE-1 Phase 3 clinical trial of PH94B, which evaluated for the acute treatment of anxiety in adults with social anxiety disorder,.
Sponsors: Lead Sponsor: VistaGen Therapeutics, Inc. Source: VistaGen Therapeutics, Inc. Brief Summary: This placebo-controlled clinical study is designed to evaluate the efficacy, safety and tolerability of administration of PH94B nasal spray four times per day as a treatment of Adjustment Disorder with Anxiety symptoms in adults.
VistaGen'sPH94B is a first-in-class, odorless, tasteless rapid-onset (10-15 minutes) investigational pherine nasal spray with a novel mechanism of action (MOA) that regulates the...
VistaGen is currently evaluating PH94B in two Phase 3 clinical studies in the U.S., PALISADE-1 and PALISADE-2, and a long-term safety study, for the acute treatment of anxiety in adults with SAD.
Apr 12, 2022 · Currently, PH94B is not approved by the FDA, the NMPA, or any other regulatory agency for use in patients outside clinical studies.Separate from PALISADE Global, VistaGen is currently evaluating PH94B in Phase 3 clinical studies and a long-term safety study that, if successful, will support VistaGen’s PH94B NDA submission to the FDA..
VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder. ... PH94B is an investigational pherine nasal spray with a unique potential mechanism of action designed to achieve rapid-onset anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects ...