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Label indication ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 ) FDA label
Zuranolone · 1 trial · 1 indication
PK Parameters of Zuranolone will be assessed.
| Arm | Type | Description |
|---|---|---|
| Zuranolone | EXPERIMENTAL | Participants will be enrolled to receive Zuranolone orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The first 10 enrolled participants will receive 50 mg (participants with a body weight of 54 kg or greater) or 40 mg (participants with a body weight less than 54 kg) once daily. The remaining participants will receive 40 mg once daily with the opportunity to down titrate to 30 mg if 40 mg is not tolerated. |
| Name | Type | Description |
|---|---|---|
| Zuranolone | DRUG | Administered as capsules |
Inclusion Criteria: * Participant meets Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime DSM-5 (KSADS-PL DSM-5) criteria for MDD. * Participant has a Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to 40 at screening and Day 1. *...
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Zuranolone is being developed for the treatment of major depressive disorder. The clinical program described here focuses on adolescent participants with major depressive disorder, a psychiatric condition in the therapeutic area of psychiatry. Zuranolone is a small molecule and remains in clinical development.
Zuranolone targets GABA-A receptor subunits, specifically GABRA1, GABRB2, GABRG2, GABRB3, GABRA4, and GABRG3. It acts as a positive allosteric modulator at these receptors. This target class places it among compounds that modulate GABA-A receptor signaling rather than acting as direct receptor agonists.
Biogen Inc. is developing Zuranolone. Biogen trades on the Nasdaq under the ticker BIIB. The company is the sponsor associated with the clinical development program for this asset in major depressive disorder.
Zuranolone is in Phase 1 clinical development. It is investigational and has not been approved. The program includes one completed Phase 1 trial, and no active trials are currently listed. A priority review designation is associated with this asset.
Zuranolone has been studied in the completed Phase 1 trial NCT05655507, titled Zuranolone Pharmacokinetics (PK) and Safety Study in Adolescent Participants With Major Depressive Disorder. That trial enrolled 19 participants in the United States, included females aged 12 years and older, and was an uncontrolled study without randomization or blinding.