• In the Phase 3 study population (N=90) of patients with PPD, LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60 (primary endpoint); the primary endpoint was not met



     
  • In a post hoc analysis of participants (n=54) who had a history of psychiatric conditions, LPCN 1154 demonstrated nominal statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo as early as hour 12 and sustained through day 30



     
  • In the overall population, LPCN 1154 was well tolerated and demonstrated a differentiated safety profile with no reported adverse event, including somnolence or dizziness, occurring in more than 5% of the LPCN 1154-treated participants



     
  • The Company plans to evaluate all available options going forward

SALT LAKE CITY, April 2, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced topline results from its Phase 3 placebo-controlled trial evaluating LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD). For more information on the trial design, refer to clinicaltrials.gov: NCT06979544.

LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary was not met. The results showed LPCN 1154 to be well tolerated and demonstrated a favorable safety profile to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations were reported.

In a post hoc analysis of participants with a history of psychiatric conditions diagnosed using Mini-International Neuropsychiatric Interview (MINI, a structured diagnostic interview used to screen for and diagnose psychiatric disorders using DSM/ICD criteria), the Company identified signals that could indicate a potential development path for LPCN 1154.

Table: Placebo-Adjusted HAM-D17 Score Change from Baseline

Timepoint

Overall Population

N=90

History of Psychiatric

Conditions Subset

N=54

Placebo-Adjusted

 Difference

Statistical

Significance

Placebo-Adjusted

Difference

Statistical

Significance

Hour 12-3.9P < 0.01-7.2P < 0.001
Hour 36-1.7NSS-5.0P < 0.05
Hour 60-1.3NSS-6.1P < 0.01
Day 7-1.2NSS-4.2NSS
Day 30-2.3NSS-5.3P < 0.05

NSS: Not Statistically Significant. Mixed model for repeated measures, least squares means placebo-adjusted difference. P-values are nominal except for Hour 60 Overall Population.

Based on the results of the post hoc analysis of efficacy among participants with a history of psychiatric condition based on the MINI, the Company has applied for breakthrough therapy and fast track designations for LPCN 1154 in patients with PPD. While the Company is waiting for feedback from the FDA on such designations, the Company plans to preserve capital and engage with stakeholders, including investors, regulators, and advisors, to evaluate all options available to the Company going forward. Such options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product candidates, strategic transactions, partnerships, and other opportunities.

The Company intends to complete its full analysis of the trial data in the coming weeks and plans to present the results at upcoming conferences. The Company thanks patients, investigators, and site staff for their contributions.