Lipocine Inc. reported that its Phase 3 study of LPCN 1154, an oral brexanolone for postpartum depression, has reached 80 % of its planned enrollment, with 66 of the 80 intended participants already randomized. The milestone confirms the study’s recruitment pace and supports the company’s plan to submit a 505(b)(2) NDA in 2026.
The company’s independent Data Safety Monitoring Board cleared the trial to continue after its first review, and the second review is scheduled for early January 2026. The enrollment rate suggests the study is on track to meet projected completion dates and to deliver topline data in the second quarter of 2026.
LPCN 1154 is an oral formulation of brexanolone designed to provide rapid relief of postpartum depression in an outpatient setting. It offers a 48‑hour dosing period and avoids the infusion and REMS requirements that limit the current FDA‑approved intravenous brexanolone (Zulresso). The product could address a significant unmet need for faster, more convenient treatment options.
Lipocine’s broader financial picture remains challenging. The company reports negative operating and net margins and declining revenue growth, and its market capitalization is around $17.4 million. The 80 % enrollment milestone is therefore a critical operational indicator that could influence the company’s near‑term valuation.
CEO Mahesh Patel said the recruiting rate is encouraging and highlighted the unmet medical need for postpartum depression treatments. He emphasized that the trial’s progress demonstrates the feasibility of the oral platform and reinforces confidence in the company’s strategy to bring LPCN 1154 to market.
The enrollment achievement underscores the feasibility of the study and positions Lipocine to potentially secure regulatory approval in 2026. While financial headwinds persist, the milestone strengthens the case for the company’s flagship product and may support investor confidence in its long‑term prospects.
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