BRLIZIO (LPCN 1154) (oral brexanolone) - (BLOOM)

Sept. 14, 2026: Lipocine Inc. (NASDAQ: LPCN) announced initiation of BLOOM, a placebo-controlled Phase 3 outpatient study of LPCN 1154 (oral brexanolone; proposed brand name BRLIZIO) for severe postpartum depression, with first participant dosing expected in early Q4 2026.

BLOOM is planned to enroll about 120 participants and is intended to support a potential 505(b)(2) NDA. The primary endpoint is change from baseline in HAM-D17 total score at 60 hours after dosing initiation, using the same 48-hour regimen as the prior Phase 3 study. Design changes include tighter site-quality controls, measures to reduce placebo response, and prespecified sensitivity analyses for outlier sites and pharmacokinetic data.

The company said the prior Phase 3 trial missed its primary endpoint in the full analysis set, but post hoc analyses found anomalies at one high-enrolling site, including no detectable study drug in blood samples from about 40% of treated participants there; excluding that site suggested rapid and sustained symptom improvement. These analyses were described as exploratory, not confirmatory.

Lipocine also said the prior trial showed favorable safety/tolerability, with no treatment-related severe or serious adverse events and no excessive sedation, loss of consciousness, or discontinuations. The company expects existing resources to fund BLOOM, with average cash use of about $1 million per month.