Progress Update: LPCN 1154 for the Treatment of Postpartum Depression

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Lipocine Inc today shared an update on its ongoing pivotal phase 3 clinical trial evaluating oral brexanolone (LPCN 1154) for the treatment of postpartum depression (PPD): The study is on track, with one-third of planned participants randomly assigned. Investigators anticipate topline results in the second quarter of 2026.¹

LPCN 1154 is an oral formulation of brexanolone in development targeted for rapid relief of PPD. The pivotal, randomized, double-blind study (NCT06979544) is evaluating LPCN 1154 compared with placebo in women aged 15 years and older diagnosed with severe PPD.² The trial aims to determine if LPCN 1154 reduces depressive and anxiety symptoms in subjects with severe PPD, and how well participants tolerate LPCN 1154. Following feedback from the US Food and Drug Administration (FDA), the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a health care provider.

"We are very encouraged by the steady enrollment momentum in our pivotal phase 3 trial and are pleased to see the program advance as planned," said Mahesh Patel, the CEO of Lipocine. "LPCN 1154 is designed to be differentiated from existing options for PPD, with its 48-hour dosing schedule, and potential for rapid, meaningful clinical benefit. We believe it has the potential to become the standard of care for women suffering from this condition. We intend to use the data from this phase 3 trial to support a 505(b)(2) NDA submission in 2026."¹

LPCN 1154 is anticipated to be an at home treatment with easier treatment access than the current standard of care option that requires hospitalization and significant limitations. Additionally, LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with PPD, such as a greater level of privacy for a mother, no bonding/breast feeding interruptions due to hospitalizations. Moreover, LPCN 1154 could also appeal to individuals with acutely elevated suicide risk, and in whom rapid improvement is a priority. Notably, LPCN 1154 presents no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.

The independent Data Safety Monitoring Board (DSMB) will meet to review safety data from the study in the one-third patients randomized, and Lipocine plans to provide a safety update in the fourth quarter of 2025 following this DSMB review.

"PPD is a serious and potentially life-threatening condition. LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option. We believe a 48-hour oral dosing duration with fast onset of efficacy would be an important solution for patients and caregivers,” said Patel.³

Back in June 2021, the FDA cleared Lipocine’s Investigational New Drug Application to initiate a phase 2 study to evaluate the therapeutic potential of LPCN 1154 for the treatment of PPD in adults.⁴ Then on July 9, 2025, Lipocine hosted a virtual research and development investor event to discuss LPCN 1154. The event featured a discussion by Kristina M. Deligiannidis, MD, from Zucker Hillside Hospital in Northwell Health, New York, who was joined by company management to discuss the current treatment landscape and unmet needs in PPD.

References

1. Lipocine provides progress update on LPCN 1154 phase 3 clinical trial in postpartum depression (PPD). News release. September 30, 2025. Accessed September 30, 2025. https://www.benzinga.com/pressreleases/25/09/n47938621/lipocine-provides-progress-update-on-lpcn-1154-phase-3-clinical-trial-in-postpartum-depression-ppd

2. A study to assess the safety and efficacy of oral LPCN 1154A in women with severe PPD. Clinicaltrials.gov. Accessed September 30, 2025. https://clinicaltrials.gov/study/NCT06979544

3. Lipocine announces LPCN 1154 meets bioequivalence with IV brexanolone in pivotal study. News release. June 25, 2024. Accessed September 30, 2025. https://www.prnewswire.com/news-releases/lipocine-announces-lpcn-1154-meets-bioequivalence-with-iv-brexanolone-in-pivotal-study-302180958.html

4. LPCN 1154: an oral neurosteroid being developed for the treatment of postpartum depression. Lipocine Inc. Accessed September 30, 2025. https://www.lipocine.com/pipeline/lpcn-1154-copy/