Lipocine Inc. has announced the completion of the second scheduled independent Data Safety Monitoring Board (DSMB) review for its ongoing Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, for the rapid relief treatment of postpartum depression $(PPD)$. The DSMB assessed all available safety data from 82 randomized participants, with 74 having completed dosing, and recommended the trial continue as planned without modification. No drug discontinuations, excessive sedation, loss of consciousness, or drug-related serious adverse events have been reported. The company is no longer screening new participants but continues to enroll those who have already met eligibility criteria. Lipocine expects to report topline safety and efficacy results from the study early in the second quarter of 2026.

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