Drugs / Brexanolone
Brexanolone
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ZULRESSO | — | 2022-06-16 | fda.gov ↗ |
| Approved | US (FDA) | ZULRESSO | — | 2019-03-19 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05314153 | Feb 2022 → Jun 2024 | postpartum psychosis | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05223829 | Aug 2023 → Dec 2025 overdue | alcohol-related disorders, post-traumatic stress disorder | Yale University | Active not recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02052739 | Mar 2014 → May 2015 | new-onset refractory status epilepticus | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT05645432 | May → Nov 2023 | tinnitus | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02614547 | Dec 2015 → Jun 2016 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT02285504 | Jan → Jun 2015 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02277106 | Sep 2014 → Aug 2015 | essential tremor | Sage Therapeutics | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT04537806 | Dec 2020 → Jul 2021 | COVID-19, acute respiratory distress syndrome | Sage Therapeutics | Terminated | Missed primary |
| Phase 3 | NCT03665038 | Sep 2018 → Jan 2021 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02942004 | Aug 2016 → Sep 2017 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT02942017 | Jul 2016 → Sep 2017 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT05254405 | Jun 2023 → Dec 2025 | post-traumatic stress disorder | Donald Jeffrey Newport | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT05329779 | Nov 2022 → Jul 2023 | depressive disorder | Brigham and Women's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05059600 | Oct 2021 → Jul 2022 | postpartum depression | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT02433314 | — | new-onset refractory status epilepticus | Supernus Pharmaceuticals, Inc. | No longer available | No outcome recorded |
| — | NCT03924492 | — | postpartum depression | Supernus Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT06580444 Comparator | Jul 2025 → Feb 2027 expected | alcohol-related disorders, post-traumatic stress disorder | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02477618 Comparator | Jun 2015 → Jul 2017 | new-onset refractory status epilepticus | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT04273191 Background | Feb 2020 → Aug 2021 | postpartum depression | Sage Therapeutics | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-04-02 | Lipocine Inc. | Results Lipocine Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression lipocine.com ↗
LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary was not met. |
| 2026-01-12 | Lipocine Inc. | Results Lipocine Reports Encouraging Progress Post Second Interim Safety Review in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD) lipocine.com ↗
The DSMB recommended that the trial continue as planned without modification. |
| 2025-11-18 | Lipocine Inc. | Results Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD) lipocine.com ↗
47 participants have completed dosing to date and there have been no treatment discontinuations or dose reductions required, and no reports of drug-related serious adverse events. |
| 2025-02-06 | Lipocine Inc. | Regulatory Lipocine Receives Updated Regulatory Guidance on LPCN 1154 lipocine.com ↗
Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b)(2) NDA submission. |
| 2024-10-10 | Lipocine Inc. | Results Lipocine Announces Positive Oral Brexanolone Quantitative EEG Results lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression (PPD). |
| 2024-06-25 | Lipocine Inc. | Results Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study lipocine.com ↗
Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD). |
| 2024-02-06 | Lipocine Inc. | Results Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154 lipocine.com ↗ |
| 2023-05-16 | Lipocine Inc. | Results Positive Topline Clinical Results Support Streamlined Development Pathway for LPCN 1154, Lipocine's Oral Candidate for Rapid Relief of Depression lipocine.com ↗
Lipocine Inc. (NASDAQ: LPCN), today announced positive topline results from a pilot clinical PK bridge study of LPCN 1154 (oral brexanolone) with a comparator, IV brexanolone. |
| 2022-09-15 | Lipocine Inc. | Regulatory Lipocine Announces Favorable Regulatory Pathway on Oral LPCN 1154 for Post-Partum Depression (PPD) lipocine.com ↗
FDA agrees with Lipocine establishing LPCN 1154 pathway to efficacy through a pharmacokinetic (PK) bridge to an approved IV infusion brexanolone |
| 2019-03-21 | Ligand Pharmaceuticals | Regulatory Ligand to Receive Milestone and Royalties as Result of FDA Approval of Sage Therapeutics’ ZULRESSO™ (brexanolone) Injection ligand.com ↗
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it will receive a $3 million milestone payment as a result of the U.S. Food and Drug Administration’s (FDA) approval of Sage Therapeutics’ (NASDAQ: SAGE) ZULRESSOTM (brexanolone) injection for the treatment of postpartum depression (PPD). |
| 2014-07-22 | Ligand Pharmaceuticals | Regulatory Ligand Partner SAGE Therapeutics Receives Fast Track Designation for Captisol-enabled SAGE-547 to Treat Status Epilepticus ligand.com ↗
the U.S. Food and Drug Administration (FDA) has granted fast track designation to the SAGE-547 development program. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | brexanolone | “Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two...” PMID 33181049 ↗ Nov 202012“The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.” NCT05059600 ↗ “assessed brexanolone injection (formerly SAGE-547 injection), a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors” PMID 30177236 ↗ Aug 2018 |
| Known as | BRX | “Brexanolone (BRX) injection was approved by the United States Food and Drug Administration in 2019 for the treatment of adults with postpartum depression (PPD) based on two...” PMID 33181049 ↗ Nov 2020 |
| Known as | SAGE-547 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02942017 ↗ |
| Known as | ZULRESSO | “The purpose of this research study is to find out how Zulresso®/brexanolone influences Posttraumatic Stress Disorder (PTSD) symptoms and alcohol use.” NCT06580444 ↗1“ZULRESSO (brexanolone) injection” NCT03924492 ↗ |
| Action | Activate | “a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors” PMID 30177236 ↗ Aug 2018 |
| Route | Intravenous | “Solution for injection for IV infusion” NCT02052739 ↗ |