A New Approach to Brain Health Disorders

Sage is developing novel drug candidates with the potential to transform the lives of people with brain health disorders. We continue to advance a neuroactive steroid pipeline that includes:

ZURZUVAE^® (zuranolone) CIV, in collaboration with Biogen, the first and only oral, 14-day treatment approved for adults with postpartum depression
ZULRESSO^® (brexanolone) CIV, the first treatment approved in the United States for patients 15 years and older with postpartum depression
An in-house library of >12,000 neuroactive steroid compounds

We focus our research and development efforts on modulation of GABA and NMDA receptors—two critical neurotransmitter systems. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system (CNS); NMDA is the major excitatory pathway. Both contribute significantly to regulating CNS function. Dysfunction in these two systems is known to be at the core of numerous depressive, neurological and neuropsychiatric disorders.

Developing potential therapies for brain health disorders

GABA and NMDA Receptors

GABA and NMDA receptors contribute significantly to regulating brain function. Our novel investigational compounds are intended to alter activity at these receptors by working with the brain’s natural signaling mechanisms. We believe compounds that are designed to restore balance between excitatory and inhibitory signals within the brain have the potential to treat a range of brain health disorders associated with a variety of cognitive, neurological, and behavioral symptoms.

We’ve established a translational foundation to build an innovative, differentiated portfolio.

Our distinct approach leverages a translational foundation across our discovery and clinical programs. Sage selects compounds for development that have potent activity in pre-clinical models of brain function at the network level. It is important not only that our compounds are well understood, but that our patient populations are well defined.

We make data-driven decisions, even before moving into patients. So how do we do this?

Insight from our translational experiments drives the design of deliberate, step-wise clinical trials in well-defined patient populations. Early clinical data also guide development of new investigational medications from a rich and growing library of proprietary compounds.
We identify functional biomarkers early in the process that respond to target engagement, enabling us to design and execute small, targeted studies that inform our discovery and clinical programs.
We assess brain biomarkers to further understand the biology of disease and the targets of our drugs.
We are exploring genetic and biochemical criteria to potentially identify patient populations in the future.
We translate insights between compounds and indications for better odds of success across the pipeline.