Enrollment and Dosing Complete in Phase 3 Trial of LPCN 1154 for Postpartum Depression

Enrollment and participant dosing have been completed in the phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for postpartum depression, Lipocine announced.¹ The drug has demonstrated a favorable safety profile thus far.

Currently, a total of 90 patients have been randomized in the study, which is a double-blind, placebo-controlled phase 3 trial.² The drug is being evaluated for women aged 15 years or older who have been diagnosed with severe postpartum depression. Administration is being conducted solely in outpatient settings and administration does not require medical monitoring by a healthcare provider. This administration strategy was based on constructive feedback from the US Food and Drug Administration (FDA). Change from baseline in Hamilton Depression Rating Scale score compared with placebo will be the primary endpoint measure. The trial’s secondary outcomes include changes in Hamilton Depression Rating Scale scores, Patient Global Impression Change scale response, Montgomery-Asberg Depression Rating Scale score, and Hamilton Anxiety Rating Scale score.

Patients included in the study are females between ages 15 and 45 who have had a depressive episode that began no earlier than the 3^rd trimester and later than the first 4 weeks following delivery.² Participants were less than 12 months postpartum at screening and had a Hamilton Depression Rating Scale 17-item score indicating severe depression. Individuals with a history of bipolar disorder, schizophrenia, or schizoaffective disorder; who were actively experiencing psychosis; had a history of suicidal behavior in the last year; or had a history of seizure in the last 6 months were excluded from the study.

LPCN 1154 has so far demonstrated a favorable safety profile, with no reports of drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events.

"We look forward to reporting topline safety and efficacy results early in the second quarter of 2026," said Mahesh Patel, PhD, chief executive officer of Lipocine, in a press release. Patel added in a previous press statement, “We believe LPCN 1154’s target profile, including superior tolerability, rapid therapeutic benefit, and a short 48-hour treatment course, has the potential to establish a new and improved treatment paradigm for PPD.”³

LPCN 1154 is an oral formulation of brexanolone currently in development for rapid relief of postpartum depression in a more convenient, at home environment. Lipocine noted the drug has potential to be a first line treatment option for women with postpartum depression. Patients needing rapid symptom relief, like those with elevated suicide risk, could benefit particularly from this medication, the company said. Current treatment options have more delayed onset and concerns with tolerability, which this medication may offer an improvement upon.

The phase 3 trial is no longer screening new participants but is continuing enrollment for patients already having met eligibility criteria. Phase 3 trial data are expected to support a 505(b)(2) New Drug Application for LPCN 1154 in 2026.

References

1. Lipocine announces completion of enrollment and dosing in phase 3 trial of LPCN 1154 in postpartum depression. Press release. January 20, 2026. Accessed January 20, 2026. https://www.prnewswire.com/news-releases/lipocine-announces-completion-of-enrollment-and-dosing-in-phase-3-trial-of-lpcn-1154-in-postpartum-depression-ppd-302664877.html

2. A study to assess the safety and efficacy of oral LPCN 1154A in women with severe PPD. ClinicalTrials.gov. September 2025. Accessed January 20, 2026. https://clinicaltrials.gov/study/NCT06979544

3. Lipocine reports encouraging progress post second interim safety review in phase 3 trial of LPCN 1154 in postpartum depression. Press release. January 12, 2026. Accessed January 20, 2026. https://www.lipocine.com/news-article/lipocine-reports-encouraging-progress-post-second-interim-safety-review-in-phase-3-trial-of-lpcn-1154-in-postpartum-depression-ppd/