Lipocine: DSMB recommended Phase 3 LPCN 1154 continue as planned

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 second of two DSMB reviews planned during the study. The DSMB recommended that the trial continue as planned without modification. The DSMB recommendation was based on assessment of available safety data collected from 82 randomized participants, of which 74 had completed dosing. There have been no treatment discontinuations or reports of drug-related serious adverse events. No cases of excessive sedation or loss of consciousness have been reported to date. The one reported case of a dose reduction was due to an adverse event. The study is no longer screening new participants, however the company continues to enroll the additional participants who have met the eligibility criteria. The company is on track to report topline safety and efficacy results early in the second quarter of 2026. “The data generated to date reinforces our confidence in the safety profile of LPCN 1154,” said Mahesh Patel, CEO of Lipocine. “We believe LPCN 1154’s target profile, including superior tolerability, rapid therapeutic benefit, and a short 48-hour treatment course, has the potential to establish a new and improved treatment paradigm for PPD. We look forward to sharing results from our Phase 3 study in the second quarter of 2026.”