First Participant in Phase 3 Study of LPCN 1154 for Postpartum Depression

The first participant has been dosed in the Brexanolone Lifting Outcomes of Moms (BLOOM) study, Lipocine’s phase 3 trial evaluating oral brexanolone (LPCN 1154) for postpartum depression (PPD). LPCN 1154—an investigational oral formulation of brexanolone that is chemically identical to the naturally occurring neuroactive steroid allopregnanolone, which modulates GABA-_A receptors—is being developed as a 48-hour oral, at-home treatment.¹

The placebo-controlled outpatient study is designed to evaluate efficacy and safety and complement the existing clinical data package in support of a potential New Drug Application (NDA) under the 505(b)(2) pathway.

"Our goal is to develop a treatment that provides rapid symptom relief through a 48-hour oral course taken at home," said Mahesh Patel, the president and chief executive officer of Lipocine. "We believe the BLOOM phase 3 study is designed to promote study enrollments that are representative of the actual patient population of postpartum depression and provide confidence in data quality."

About the BLOOM Study

The BLOOM study, initiated in September 2026,² is expected to enroll approximately 120 participants with PPD. The study builds on Lipocine’s prior phase 3 trial, which did not meet its primary endpoint in the full analysis set. Despite this trial failure, safety outcomes and exploratory post hoc findings supported further evaluation of LPCN 1154. BLOOM therefore incorporates lessons from the prior trial along with FDA feedback, equating to strengthened site selection, eligibility assessments, and data quality controls. These measures are intended to improve study execution and the interpretability of results. Notably, they do not establish efficacy or assure a successful outcome.

Consistent with this completed phase 3 trial, BLOOM will evaluate the same 48-hour dosing regimen and primary efficacy endpoint (change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score at 60 hours after dosing initiation).

There will be third-party support for site selection, geographic diversity, participation by academic sites, limitation of the number of participants at each site, and periodic review of site participant populations. Sites flagged for significant operational or data-quality concerns will not be selected for inclusion.

Importantly, the protocol includes fewer rating scales and assessments, reduced participant contact with site staff, centralized rating for screening and eligibility, and standardized participant education about study procedures and assessments. The intent from investigators is to reduce placebo response.

Lastly, planned analyses will address outlier sites and pharmacokinetic data to help assess the robustness of the study findings.

Next Steps

The dosing of the first participant marks an important first step in advancing LPCN 1154’s clinical development program towards an NDA submission. Topline results from the BLOOM study are expected in the second quarter of 2027.

References

1. Lipocine doses first participant in BLOOM phase 3 study of LPCN 1154 for postpartum depression. News release. November 10, 2026. Accessed November 10, 2026. https://ir.lipocine.com/2026-11-10-Lipocine-Doses-First-Participant-in-BLOOM-Phase-3-Study-of-LPCN-1154-for-Postpartum-Depression

2. Kuntz L. Initiation of BLOOM phase 3 study of LPCN 1154 for postpartum depression. Psychiatric Times. September 15, 2026. https://www.psychiatrictimes.com/view/initiation-of-bloom-phase-3-study-of-lpcn-1154-for-postpartum-depression