NDAORALCAPSULEPriority Review
Approved
Aug 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
ZURZUVAE (zuranolone) by Biogen is gaba a receptor positive modulators [moa]. First approved in 2023.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZURZUVAE (zuranolone) is an oral neuroactive steroid that acts as a GABA-A receptor positive modulator, enhancing inhibitory neurotransmission in the central nervous system. Approved in August 2023, it represents a novel mechanism for treating depression and related psychiatric disorders. The drug is administered as an oral capsule, offering a convenient non-IV alternative to existing GABA-modulating therapies.
Growth11.2 years to LOE
Early-stage growth phase with 11+ years of patent protection suggests expanding commercial infrastructure and sustained hiring for field, marketing, and medical affairs roles.
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
200 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
200 enrolled
Depression, Postpartum
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
Started Apr 2023
19 enrolled
Major Depressive Disorder
Career Relevance
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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.