INSIGHTS & POINT OF VIEW Sage Thoughts

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“In Their Words”: Katie and Mike’s journey with Huntington’s disease
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At the Crossroads of Innovation and Policy, People Suffer
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Brain Works
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News The latest from Sage

press releases

Company Statement: Investigational SAGE-718 Granted Nonproprietary Name of Dalzanemdor

events

Piper Sandler 35th Annual Healthcare Conference

sage thoughts

At Sage, we believe we see possibilities where others do not and are working to find potential ways to treat people with brain health disorders. Sage Thoughts provides insights and points of view about brain health.

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PATIENTS & CARE PARTNERS Putting patients and their families first

We are rethinking care and how it is delivered to help patients and families impacted by brain health disorders.

See our resources for patients
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HEALTHCARE PROVIDERS It’s an exciting time in neuroscience

At Sage, our goal is to originate meaningfully differentiated drug candidates. We aim to discover new pathways to brain health by making medicines that matter so patients can get better, sooner.

 

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CLINICAL TRIALS A distinct approach to neuroscience drug development

Sage is committed to developing new medicines to treat life-altering brain health disorders.
LEARN MORE ABOUT OUR ONGOING CLINICAL TRIALS

PIPELINE Advancing a leading brain health portfolio

We seek to make a positive impact on the unmet treatment needs of patients by advancing product candidates from a robust development pipeline of potential brain health disorder treatments.
Compound
Target Indications
Phase 1
Phase 2
Phase 3
Status
Postpartum Depression Franchise
ZULRESSO®
(brexanolone) CIV injection
  • Postpartum Depression
Marketed
Marketed
ZURZUVAE™*
(zuranolone)
  • Postpartum Depression
FDA APPROVED
FDA APPROVED
Neuropsychiatry Franchise
Zuranolone*
(SAGE-217)
  • Major Depressive Disorder**
IN PHASE 3
IN PHASE 3
Dalzanemdor
(SAGE-718)
  • Huntington’s Disease Cognitive Dysfunction
IN PHASE 2
IN PHASE 2
  • Parkinson’s Disease Cognitive Dysfunction
IN PHASE 2
IN PHASE 2
  • Alzheimer’s Disease Mild Cognitive Impairment and Mild Dementia
IN PHASE 2
IN PHASE 2
SAGE-324*
  • Essential Tremor
IN PHASE 2
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 ZULRESSO and the U.S. Prescribing Information for ZURZUVAE
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.

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CAREERS Rethinking brain health disorders to make life better for patients and their families

Sage is a place where unconventional thinking to solve problems with new ideas is welcome - and where unconventional thinkers can imagine what's possible and do big.
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