Phase 3 Top Line Results Expected Q2 2026
Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced that the first patient has been dosed in its pivotal Phase 3 clinical trial of LPCN 1154 (oral brexanolone), its investigational oral treatment for postpartum depression (PPD).
Following FDA feedback, this study is being conducted in an outpatient setting, with no requirement for medical monitoring by a healthcare provider. The Company anticipates using the data from this Phase 3 trial to support an NDA submission of LPCN 1154 for PPD in mid-2026.
The trial is a two-arm, randomized, blinded study evaluating LPCN 1154 compared to placebo in women aged 15 years and older with severe PPD. The treatment regimen involves a 48-hour dosing period which was informed by the dosing in Lipocine’s successful PK bio-bridge study with injectable brexanolone. The study is being conducted at multiple clinical sites across the U.S.
The primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D), a widely recognized clinical measure of depression severity. Additional secondary endpoints include the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to assess anxiety symptoms, as well as key safety and tolerability measures. The trial size is powered based on the treatment effect observed with the FDA approved injectable brexanolone. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. For more information, refer to ClinicalTrials.gov ID NCT06979544.
“Given the unmet need for rapid relief, this Phase 3 trial is an important step in our development program to bring LPCN 1154 to women suffering from postpartum depression,” said Mahesh Patel, CEO of Lipocine. “By offering a novel bioidentical oral treatment with 48-hour treatment duration and expected robust efficacy, LPCN 1154 is designed to be a differentiated, rapid relief product with the potential to be the standard of care.”
Virtual Investor Event on LPCN 1154
Lipocine will host a virtual research and development (R&D) investor event to discuss LPCN 1154 on Wednesday, July 9, 2025 at 11:00 AM ET. The event will feature Kristina M. Deligiannidis, MD (Zucker Hillside Hospital, Northwell Health, New York), who will join company management to discuss the current treatment landscape and unmet needs in PPD.
