Lipocine provides update on Phase 3 clinical trial in postpartum depression

Lipocine (LPCN) provided an update on its ongoing pivotal Phase 3 clinical trial evaluating LPCN 1154 for the treatment of postpartum depression, or PPD. The study is progressing on track with one-third of planned patients randomized. Topline results are anticipated in 2Q26. A meeting of the independent Data Safety Monitoring Board, or DSMB, to review safety data from the study in the one-third patients randomized will be held, and the company plans to provide a safety update in Q4 post DSMB review. The study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following feedback from the FDA, the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider.