Lipocine's postpartum depression drug fails primary endpoint in phase 3 trial

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

April 2, 2026 8:00 AM EDT

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... More