We are developing new medicines to make life better for patients suffering from rare, life-threatening CNS disorders.
Our different approach to drug discovery and development has allowed us to create and advance multiple candidates with the potential to treat a range of central nervous system (CNS) disorders.
Our proprietary approach to drug discovery and development has generated selective compounds with precise pharmacologic properties that may be applied to the treatment of multiple CNS disorders. These compounds, which we call next-generation neurosteroids, have improved pharmacokinetic properties that may allow for both oral availability and improved therapeutic indexes. As a result, they may be better suited for long-term, or chronic, use. SAGE-689 and SAGE-217 are next-generation neurosteroids we have selected as clinical candidates.
Our lead product candidate, brexanolone, is administered as an intravenous therapy designed to correct imbalances in GABA signaling within the brain.1 Brexanolone injection is a proprietary formulation of allopregnanolone, a naturally-occurring nerve signaling molecule, known to modulate GABA receptor activity.
Brexanolone has completed Phase 3 clinical development for postpartum depression and a New Drug Application is currently under review with the U.S. Food and Drug Administration. Brexanolone has been granted PRIME designation by the European Medicines Agency.
SAGE-217 is a novel, selective, next generation GABAA positive allosteric modulator that shares similar pharmacology properties to brexanolone. We are initially developing SAGE-217 as a once-daily, oral therapy for treatment of various CNS disorders.