Lipocine doses first patient in Phase 3 trial for oral brexanolone (LPCN 1154) in postpartum depression

Lipocine Inc.

First patient dosed in pivotal Phase 3 trial of LPCN 1154 (oral brexanolone) for postpartum depression; top line data expected Q2 2026.
Trial is outpatient with no medical monitoring required; 48-hour treatment regimen, randomized, blinded vs placebo in women ≥15 with severe PPD.
Primary endpoint is change from baseline in HAM-D scale; NDA submission targeted for mid-2026 based on Phase 3 data.
Virtual investor event on LPCN 1154 scheduled for July 9, 2025 at 11:00 AM ET.

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