LPCN 1154 for postpartum depression continues clinical process after safety review

An independent Data Safety Monitoring Board (DSMB) has recommended that a pivotal phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, continue as planned for the rapid relief treatment of postpartum depression (PPD), according to a press release from Lipocine Inc. The DSMB review represents the second of 2 planned safety assessments during the study and found no safety concerns in the trial, which will now proceed without modification, according to an announcement from Lipocine Inc.¹

The phase 3 trial’s (NCT06979544)² available safety data were from 82 randomized participants, 74 of whom had completed dosing at the time of the analysis. Investigators reported no treatment discontinuations and no drug-related serious adverse events. There were no cases of excessive sedation or loss of consciousness. One dose reduction was reported, which occurred in response to an adverse event.¹

The trial is a randomized, double-blind, placebo-controlled study evaluating LPCN 1154 in females aged 15 years and older diagnosed with severe PPD. After receiving feedback from the FDA, the trial is being conducted entirely in an outpatient setting, and administration of the investigational therapy does not require medical monitoring by a health care provider. Data from the study are expected to support a 505(b)(2) new drug application submission in 2026. The company plans to report topline safety and efficacy results “early in the second quarter of 2026.”

While the trial is no longer screening new participants, enrollment is continuing for individuals who have already met eligibility criteria.

“The data generated to date reinforces our confidence in the safety profile of LPCN 1154," said Mahesh Patel, CEO of Lipocine, in a statement.

PPD is a major depressive disorder that can begin during pregnancy or within weeks after delivery, with symptoms that may persist for up to a year following childbirth. Hormonal changes associated with pregnancy and the postpartum period are believed to contribute to dysregulation of gamma-aminobutyric acid signaling, a pathway implicated in depressive disorders.

Symptoms of PPD can include persistent sadness, loss of interest, fatigue, sleep disturbances, difficulty concentrating, excessive crying, fear of harming oneself or the baby, and suicidal ideation. According to survey data cited by the company, obstetricians estimate that approximately 20% to 40% of their patients may experience PPD.

While clinicians are generally comfortable diagnosing and prescribing antidepressants for PPD, traditional antidepressant therapies are not approved for this indication, often have a delayed onset of action, and may be associated with side effects or inadequate remission.

"We believe LPCN 1154's target profile, including superior tolerability, rapid therapeutic benefit, and a short 48-hour treatment course, has the potential to establish a new and improved treatment paradigm for PPD,” said Patel.

References:

1. Lipocine reports encouraging progress post second interim safety review in phase 3 trial of LPCN 1154 in postpartum depression. Lipocine Inc. Press release. Published January 12, 2026. Accessed January 16, 2026. https://prnmedia.prnewswire.com/news-releases/lipocine-reports-encouraging-progress-post-second-interim-safety-review-in-phase-3-trial-of-lpcn-1154-in-postpartum-depression-ppd
2. A study to assess the safety and efficacy of oral OPCN 1154A in women with severe PPD. ClinicalTrials.gov. Updated September 12, 2025. Accessed January 16, 2026. https://clinicaltrials.gov/study/NCT06979544