Pipeline

At Sage we're advancing a leading brain health portfolio.

Compound

Target Indications

Phase 1

Phase 2

Phase 3

Status

Postpartum Depression Commercial Products

ZURZUVAE™*
(zuranolone) CIV

Postpartum Depression

Marketed

ZULRESSO®
(brexanolone) CIV injection

Postpartum Depression

Marketed

Pipeline

Zuranolone*
(SAGE-217)

Major Depressive Disorder**

IN PHASE 3

Dalzanemdor
(SAGE-718)

Huntington’s Disease Cognitive Dysfunction

IN PHASE 2

Parkinson’s Disease Cognitive Dysfunction

IN PHASE 2

Alzheimer’s Disease Mild Cognitive Impairment and Mild Dementia

IN PHASE 2

SAGE-324*

Essential Tremor

IN PHASE 2

Programs In Evaluation

SAGE-689

Acute GABA Hypofunction
SAGE-421

NMDA Hypofunction
SAGE-319

GABA 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.