Salt Lake City, UT — Lipocine Inc. announced positive progress in its pivotal phase 3 clinical trial evaluating oral brexanolone (LPCN 1154) for the treatment of postpartum depression (PPD). The study has reached one-third of its planned enrollment, with topline results expected in the second quarter of 2026.
LPCN 1154 is an oral formulation of brexanolone being developed to provide rapid relief from symptoms of PPD. The ongoing pivotal trial (NCT06979544) is a randomized, double-blind, placebo-controlled study enrolling women aged 15 years and older diagnosed with severe PPD. The trial is designed to assess the efficacy, safety, and tolerability of LPCN 1154 in reducing depressive and anxiety symptoms associated with PPD.
Following guidance from the US Food and Drug Administration (FDA), the phase 3 trial is being conducted entirely in an outpatient setting, eliminating the need for continuous medical supervision.
“We are very encouraged by the steady enrollment momentum in our pivotal phase 3 trial and pleased to see the program advancing as planned,” said Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. “LPCN 1154 is designed to stand apart from existing treatment options with its convenient 48-hour oral dosing schedule and potential for rapid, meaningful symptom improvement. We believe LPCN 1154 has the potential to become the new standard of care for women suffering from postpartum depression, and we plan to use these phase 3 data to support a 505(b)(2) NDA submission in 2026.”
If approved, LPCN 1154 could represent a transformative at-home treatment option—offering greater accessibility and convenience than the current standard of care, which typically requires hospitalization and medical monitoring. The oral formulation is also expected to minimize disruptions to maternal bonding and breastfeeding, enhance privacy, and address the urgent needs of patients at high risk for suicidal ideation by providing rapid symptom relief. Importantly, LPCN 1154 carries no significant risk of adverse effects for breastfed infants exposed to brexanolone.
An independent Data Safety Monitoring Board (DSMB) will conduct an interim review once one-third of participants have been randomized, with Lipocine planning to share a safety update in the fourth quarter of 2025.
“Postpartum depression is a serious, potentially life-threatening condition that affects mothers and families worldwide,” added Patel. “We believe LPCN 1154’s unique profile—as an oral, fast-acting therapy with a short 48-hour dosing duration—could deliver a significant improvement for patients and caregivers seeking effective, accessible treatment.”
