Pipeline
At Sage we're advancing a leading brain health portfolio.
(zuranolone) CIV
- Postpartum Depression
(brexanolone) CIV injection
- Postpartum Depression
(SAGE-217)
- Major Depressive Disorder**
(SAGE-718)
- Huntington’s Disease Cognitive Impairment
- Alzheimer’s Disease Mild Cognitive Impairment and Mild Dementia
- Essential Tremor
-
SAGE-689Acute GABA Hypofunction
-
SAGE-421NMDA Hypofunction
-
SAGE-319GABA Hypofunction
*Collaboration Partners: Biogen Inc., and Shionogi for zuranolone and Biogen Inc. for SAGE-324
**The FDA issued a CRL on August 4, 2023, related to the NDA for the treatment of adults with MDD stating that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. No Phase 3 trials are currently ongoing.
Please refer to the
U.S. Prescribing Information for ZURZUVAE
and the
U.S. Prescribing Information for ZULRESSO
Safety and efficacy for investigational uses or compounds have not been established. There is no guarantee that the outcome of these studies will be positive or result in approval by a Health Authority.