The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).

SAGE-217 is a novel, orally-active, second-generation neuroactive steroid that acts as a positive allosteric modulator of synaptic and extrasynaptic GABAA receptor subtypes. Its unique pharmacokinetic profile and selective properties allow for once-daily oral dosing while minimizing potential off-target side-effects. 

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Sage is currently investigating SAGE-217 in a Phase 2 clinical development program, including four studies in both mood and movement disorders.  

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