Lipocine Reports Positive Interim Safety Results in Phase 3 Trial of Oral PPD Treatment
Reuters
Nov 18, 2025
Lipocine Reports Positive Interim Safety Results in Phase 3 Trial of Oral PPD Treatment
Lipocine Inc. announced the completion of a scheduled independent Data Safety Monitoring Board (DSMB) review for its ongoing Phase 3 clinical trial evaluating LPCN 1154, an oral brexanolone product candidate for the rapid relief of postpartum depression $(PPD)$. The DSMB recommended that the trial continue as planned without modification after reviewing safety data from approximately one-third of the planned 80 participants. To date, 47 participants have completed dosing with no reported drug-related serious adverse events, dose reductions, discontinuations, excessive sedation, or loss of consciousness. Topline results from the Phase 3 study are expected in the second quarter of 2026.
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