PR Newswire·Nov 10, 2026, 8:00 AM ET

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

Lipocine Inc. announced that the first participant has been dosed in the BLOOM Phase 3 study for LPCN 1154 (oral brexanolone) for postpartum depression.
LPCN 1154 is an investigational 48-hour oral treatment designed for at-home use to provide rapid symptom relief.
The BLOOM study is a placebo-controlled outpatient trial expected to enroll approximately 120 participants.
Topline results from the BLOOM study are projected for the second half of 2027.
The study design incorporates lessons from a prior Phase 3 trial that did not meet its primary endpoint, including enhanced site selection, eligibility assessments, and data quality controls.
Key design measures include third-party support for site selection, geographic diversity, limiting participant numbers per site, and protocols to reduce placebo response.
The primary efficacy endpoint is the change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score at 60 hours after dosing initiation.
Lipocine aims to submit a New Drug Application (NDA) under the 505(b)(2) pathway, contingent on a positive Phase 3 trial outcome as requested by the FDA.
LPCN 1154 is chemically identical to allopregnanolone but remains unapproved by the FDA, with efficacy & safety subject to ongoing clinical evaluation.
No head-to-head trials have established the superiority of LPCN 1154 over currently approved postpartum depression treatments.