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Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026.
About this update from Lipocine Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026","length":86,"tagName":"p"}]},{"val":[{"type":"text","content":"Topline results on track for the second quarter of 2026","length":55,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":141,"olType":false},{"type":"text","content":"SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026. Following the first DSMB review, the board recommended that the trial continue as planned without modification.","length":662,"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":""We are encouraged by the recruiting rate in our Phase 3 study for postpartum depression, which may be indicative of this population's unmet medical need," said Mahesh Patel, CEO of Lipocine. "We extend our deepest gratitude to the patients, their families, and the dedicated clinical teams at the trial sites whose commitment has made this progress possible."","length":384,"tagName":"p"},{"type":"text","content":"About the Phase 3 Study","length":23,"tagName":"p"},{"type":"text","content":"The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe P...