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Lipocine Announces First Patient Dosed in Phase 3 Clinical Trial for LPCN 1154 in Postpartum Depression
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).
About this update from Lipocine Inc.
[{"type":"text","content":"Phase 3 Top Line Results Expected Q2 2026","length":41,"tagName":"p","attribs":{}},{"type":"text","content":"SALT LAKE CITY, June 26, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).","length":404,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Lipocine Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Lipocine Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":113,"url":"https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/KThUSUCVqrvKmZyz_JDnJA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5OTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2","width":400,"height":113}},"href":"https://mma.prnewswire.com/media/627654/Lipocine_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider. The Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.","length":279,"tagName":"p"},{"type":"text","content":"The trial is a two-arm, randomized, blinded study evaluating LPCN 1154 compared to placebo in women aged 15 years and older with severe PPD. The treatment regimen involves a 48-hour dosing period which was informed by the dosing in Lipocine's successful PK bio-bridge study with injectable brexanolone. The study is being conducted at multiple clinical sites across the U.S.","length":378,"tagName":"p"},{"type":"text","content":"The primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D), a widely recognized clinical measure of depression severity. Additional secondary endpoints include the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to assess anxiety symptoms, as well as key safety and tolerabil...