Product Description
Allopregnanolone, today best known as brexanolone and marketed as Zulresso™ for the treatment of postpartum depression is part of only two recently Food and Drug Administration (FDA)-approved fast-acting antidepressants, with esketamine nasal spray, an NMDA receptor antagonist used in treatment-resistant depression being the other (Sourced from: https://www.frontiersin.org/articles/10.3389/fendo.2020.00236/full)
Mechanisms of Action: GABA Modulator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Depression, Postpartum | Depressive Disorder
Known Adverse Events: Flushing
Company: Sage
Company Location: CAMBRIDGE MA 02142
Company CEO: Barry E. Greene
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 2: Alcoholism|Stress Disorders, Post-Traumatic|Tinnitus
Phase 1: Psychotic Disorders|Schizophrenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| AS210006-A09 | P2 |
Not yet recruiting |
Stress Disorders, Post-Traumatic|Alcoholism |
2027-02-26 |
|
| U54AA027989 | P1 |
Recruiting |
Stress Disorders, Post-Traumatic|Alcoholism |
2024-12-31 |
|
| NCT05314153 | P1 |
Completed |
Psychotic Disorders|Schizophrenia |
2024-06-01 |
|
| 547-TRM-201 | P2 |
Completed |
Tinnitus |
2023-11-21 |