Lipocine Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression

In the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60 (primary endpoint); the primary endpoint was not met In a post hoc analysis of participants (n=54) who had a history of psychiatric conditions, LPCN 1154 demonstrated nominal statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo as early as hour 12 and sustained through day 30 In the overall population, LPCN 1154 was well tolerated and demonstrated a differentiated safety profile with no reported adverse event, including somnolence or dizziness, occurring in more than 5% of the LPCN 1154-treated participants The Company plans to evaluate all available options going forward SALT LAKE CITY, April 2, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design, refer to clinicaltrials.gov: NCT06979544.