Zuranolone

Generic Name
Zuranolone
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C25H35N3O2
CAS Number
1632051-40-1
Unique Ingredient Identifier
7ZW49N180B
Background

Zuranolone is a neuroactive steroid that acts as a positive allosteric modulator of the GABA receptors. Unlike other more common GABA positive allosteric modulators on the market like benzodiazepines, zuranolone can modulate both synaptic and extrasynaptic GABA conductance due to binding to a non-benzodiazepine site on the receptor. Zuranolone was designed with a pharmacological profile of a neuroactive steroid in mind while also possessing a pharmacokinetics profile of an oral, once-daily dosing formulation.

Zuranolone was approved by the FDA on August 4th, 2023, and it is currently the only approved treatment for women with postpartum depression. This approval was based on favorable results from 2 phase 3 clinical trials.

Indication

Zuranolone is indicated for the treatment of postpartum depression (PPD) in adults.

Associated Conditions
Postpartum Depression
Associated Therapies
-

Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-12-19
Last Posted Date
2024-11-18
Lead Sponsor
Sage Therapeutics
Target Recruit Count
19
Registration Number
NCT05655507
Locations
🇺🇸

Sage Investigational Site, Cincinnati, Ohio, United States

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