Product Description
Allopregnanolone, today best known as brexanolone and marketed as Zulressoâ"¢ 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: *
Approval Status: Approved
Approved Countries: United States
Approved Indications: None
Known Adverse Events: None
Company: Sage
Company Location: Eastern America
Company Founding Year: 1989
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Czech Republic, Slovakia, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
- PDUFA target date for Zulresso™ is March 19, 2019, planned U.S. launch in June 2019 pending DEA scheduling.
Highest Development Phases
Phase 3: Depression, Postpartum
Phase 2: Alcoholism|Alzheimer Disease|Depressive Disorder, Major|Stress Disorders, Post-Traumatic|Tinnitus
Phase 1: Psychotic Disorders|Schizophrenia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05223829 |
U54AA027989 | P1 |
Active, not recruiting |
Stress Disorders, Post-Traumatic|Alcoholism |
2025-12-31 |
50% |
2025-10-15 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05314153 |
NCT05314153 | P1 |
Completed |
Psychotic Disorders|Schizophrenia |
2024-06-01 |
14% |
2024-08-27 |
Primary Endpoints|Treatments|Trial Status |
NCT07065240 |
BUOY-1 Study | P2 |
Recruiting |
Depressive Disorder, Major |
2027-03-01 |
2% |
2025-07-16 |
Primary Endpoints |
NCT04838301 |
REGEN-BRAIN© | P2 |
Recruiting |
Alzheimer Disease |
2026-03-01 |
2025-05-13 |
||
NCT05645432 |
547-TRM-201 | P2 |
Completed |
Tinnitus |
2023-11-21 |
12% |
2023-12-23 |
|
NCT06979544 |
LPCN 1154-24-002a | P3 |
Completed |
Depression, Postpartum |
2026-01-16 |
9% |
2026-02-25 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT06580444 |
AS210006-A09 | P2 |
Not yet recruiting |
Stress Disorders, Post-Traumatic|Alcoholism |
2027-02-26 |
12% |
2024-09-04 |
Primary Endpoints |
2025-522347-18-00 |
SPT-300-2024-204 | P2 |
Not yet recruiting |
Depressive Disorder, Major |
2027-01-30 |
2% |
||
2025-521240-37-00 |
SPT-300-2024-203 | P2 |
Not yet recruiting |
Depressive Disorder, Major |
2026-12-30 |
2% |
||
NCT07161700 |
BUOY-1 OLE Study | P2 |
Enrolling by invitation |
Depressive Disorder, Major |
2027-05-01 |
2% |
2025-10-01 |
Primary Endpoints|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/20/2026 |
News Article |
Lipocine Announces Completion of Enrollment and Dosing in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD) |
|
01/12/2026 |
News Article |
Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD) |
|
12/16/2025 |
News Article |
Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone |
|
11/19/2025 |
News Article |
Alzheimer's Drug Discovery Foundation Launches Milestones in Motion Campaign and Announces Fifth Season of Symposium Series in Palm Beach |