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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 an investigational small molecule being developed for the treatment of Major Depressive Disorder (MDD). It is currently in clinical development and has not been approved by the FDA. A Phase 1 study has been completed to evaluate its pharmacokinetics and safety in adolescent participants with MDD.
Zuranolone is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with Major Depressive Disorder.
Zuranolone is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug's pharmacokinetics and safety in adolescent participants with Major Depressive Disorder. The drug is investigational and has not received FDA approval.
Zuranolone has one completed clinical trial, NCT05655507, titled 'Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)'. This Phase 1 study enrolled 19 female participants aged 12 years and older in the United States.
Zuranolone is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Major Depressive Disorder. The FDA has granted it Priority Review designation, but it remains under investigation and has not been approved for any use.
Zuranolone is in Phase 1 clinical development for Major Depressive Disorder. One Phase 1 trial, NCT05655507, has been completed with 19 participants. The drug has received FDA Priority Review designation, though it remains investigational and unapproved.