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Astrocyte Pharmaceuticals is currently investigating several programs for the potential treatment of acute ischemic stroke, TBI, concussion, and other injuries to the brain.

The company’s lead candidate program AST-004 is a novel small molecule candidate currently in human Phase I clinical safety trials with an intravenous injection formulation suitable for administration by emergency professionals. An oral “field” formulation of AST-004 for mild TBI and concussions, and for chronic administration for neurodegenerative diseases is in preclinical development.

Human Phase II patient clinical efficacy trials of AST-004 are planned to start in approximately a year, while subsequent Phase III studies, and New Drug Application (NDA) review by regulatory agencies such as the FDA typically take an additional 2-5 years to confirm results and approve the use of a new therapeutic.