Lipocine reports ‘promising’ safety profile in Phase 3 trial of LPCN 1154

Lipocine (LPCN) announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit. The DSMB recommended that the trial continue as planned without modification. 47 participants have completed dosing to date and there have been no treatment discontinuations or dose reductions required, and no reports of drug-related serious adverse events. No cases of excessive sedation or loss of consciousness have been reported to date in the development of LPCN 1154. “We are encouraged by the safety profile observed in our clinical experience to date with our oral product candidate comprising GABAA positive allosteric modulating neuroactive steroid with low sedation,” said Mahesh Patel, CEO of Lipocine. “Target attributes of LPCN 1154, including superior tolerability, rapid relief, and a 48-hour treatment duration, could be a game changer in the treatment of PPD, a debilitating and life-threatening condition. We look forward to LPCN 1154 Phase 3 study results, expected in the second quarter of 2026.”