NDAORALCAPSULEPriority Review
Approved
Aug 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
Priority Review
ZURZUVAE (zuranolone) by Biogen is gaba a receptor positive modulators [moa]. Approved for neuroactive steroid gamma-aminobutyric acid a receptor positive modulator [epc]. First approved in 2023.
Drug data last refreshed 8h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZURZUVAE (zuranolone) is an oral neuroactive steroid GABA-A receptor positive modulator approved by the FDA in August 2023. It is indicated for the treatment of postpartum depression (PPD) in adults. The mechanism works by enhancing GABAergic inhibitory neurotransmission in the central nervous system, providing rapid symptom relief in a patient population with limited treatment options.
Peak10.9 years to LOE
Product is in peak commercial phase with limited competitive pressure; brand teams are likely focused on market penetration and awareness building in a newly established category.
Mechanism of Action
GABA A Receptor Positive Modulators
Pharmacologic Class:
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
Started Dec 2025
300 enrolled
Postpartum Depression
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
Started Jun 2025
305 enrolled
Depression, Postpartum
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
Started Apr 2023
19 enrolled
Major Depressive Disorder
Why This Matters for Your Career
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.