zuranolone

Generic: ZURANOLONE·Brand: ZURZUVAE, Zurzuvae

zuranolone: developed by 3 companies · 1 FDA decision.

What we can confirm

1 FDA record

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What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.

BioSniper AIPage evidence connected

Prepared research question

What is verified about zuranolone, and what remains unknown?

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Postpartum depression (PPD)Postpartum depression (PPD) in adultsMajor Depressive Disorder (MDD)

No additional listed-company sponsor is linked.

Development Pipeline (3)

Company	Phase	Indication
BIOGEN INC. (BIIB) Postpartum depression (PPD)	Approved	Postpartum depression (PPD)
Sage Therapeutics, Inc. (SAGE) Postpartum depression (PPD) in adults	Approved	Postpartum depression (PPD) in adults
SUPERNUS PHARMACEUTICALS, INC. (SUPN) Major Depressive Disorder (MDD)	Approved	Major Depressive Disorder (MDD)

FDA Decisions1 records

Aug 4, 2023

NDA217369Type 1 - New Molecular EntityPriorityOralCapsule

Frequently asked questions

zuranolone is being developed by BIOGEN INC., Sage Therapeutics, Inc., SUPERNUS PHARMACEUTICALS, INC..

The most recent tracked FDA decision for zuranolone is Approval, dated August 4, 2023.