LPCN Overview

Clinical Trial Update: Lipocine Inc. announced that the independent Data Safety Monitoring Board (DSMB) has reviewed its Phase 3 clinical trial for LPCN 1154, an oral treatment for postpartum depression (PPD), and recommended that the trial continue as planned without modifications.

Safety Profile: Over half of the planned participants have completed dosing with no serious adverse events, dose reductions, or reports of excessive sedation, indicating a favorable safety profile for LPCN 1154.

Expected Results Timeline: Topline results from the trial are anticipated in the second quarter of 2026, with an interim DSMB meeting and safety update expected in early 2026.

Product Overview: LPCN 1154 aims to provide rapid relief for PPD with a favorable tolerability profile, potentially becoming a first-line treatment option for women experiencing severe PPD.

Financial Results: Lipocine Inc. reported a net loss of $3.2 million for Q3 2025, with total revenues of $114,574, a significant decrease from $7.7 million in the same period in 2024. The company had $15.1 million in cash and equivalents as of September 30, 2025.

LPCN 1154 for Postpartum Depression: The Phase 3 trial for LPCN 1154, an oral treatment for postpartum depression, is ongoing, with top-line data expected in Q2 2026. A safety update will follow a review by the Data Safety Monitoring Board in November 2025.

LPCN 2101 for Epilepsy: Lipocine is considering a Phase 2 study for LPCN 2101, a treatment for epilepsy, and has two abstracts accepted for presentation at the upcoming American Epilepsy Society meeting in December 2025.

LPCN 2401 for Obesity Management: The company is exploring a Phase 2 study for LPCN 2401, aimed at obesity management, and is also looking for potential partnerships for commercialization of its drug candidates, including LPCN 1154 and LPCN 2401.

LPCN 2401 Presentation: Lipocine Inc. presented data at the ObesityWeek annual meeting, showcasing that LPCN 2401 significantly improves body composition and liver health in men with obesity over a 20-week Phase 2 trial.

Trial Results: The trial demonstrated that LPCN 2401 increased lean mass and reduced fat mass, with notable improvements in liver health markers observed as early as 4 to 8 weeks into treatment.

Safety and Tolerability: LPCN 2401 was well tolerated throughout the study, with no significant safety concerns reported over 72 weeks of exposure.

Company Overview: Lipocine is focused on developing innovative oral delivery biopharmaceuticals, with multiple candidates in various stages of development targeting significant medical needs, including obesity management and liver health.