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(brexanolone) CIV injection
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.