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 program AST-004 is a novel small molecule candidate currently completing preclinical toxicology and manufacturing activities.
Astrocyte Pharmaceuticals plans to begin human Phase I clinical safety trials for AST-004 in 2021, and then move into human Phase II patient clinical efficacy trials. Subsequent Phase IIb and 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 use of the new therapeutic.
Follow-on programs for an oral “field” formulation for mild TBI and concussions, and an oral chronic formulation for neurodegenerative diseases and migraine are being investigated.