Lipocine has announced the completion of enrolment and participant dosing in its Phase III clinical trial investigating LPCN 1154, an oral formulation of brexanolone, to treat postpartum depression (PPD).
The trial, focused on women aged 15 and above diagnosed with severe PPD, has randomised 90 patients to receive either LPCN 1154 or a placebo.
LPCN 1154 has so far displayed a favourable safety profile. No cases of excessive sedation, drug discontinuation, drug-related serious adverse events (SAEs), or loss of consciousness have been observed among participants.
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The double-blind, randomised Phase III study is being conducted entirely in an outpatient setting. It received constructive feedback from the US Food and Drug Administration (FDA).
Lipocine noted that the administration of LPCN 1154 does not require medical monitoring by a healthcare provider. Data from this trial is expected to support a 505(b)(2) new drug application submission in 2026.
LPCN 1154 is designed to provide rapid relief from PPD with convenient at-home treatment. It could offer advantages for individuals with severe PPD, particularly those at higher risk of suicide, for whom rapid improvement is essential.
PPD is a major depressive disorder with symptoms beginning during pregnancy or within four weeks after delivery, often persisting up to 12 months postpartum.
Lipocine CEO Mahesh Patel said: “We look forward to reporting topline safety and efficacy results early in the second quarter of 2026.”
Lipocine’s pipeline includes candidates targeting major depressive disorder, epilepsy, obesity management, essential tremor, preterm birth prevention, liver cirrhosis symptoms, and an FDA-approved oral testosterone product.
In June 2025, the company initiated subject dosing in its two-arm, blinded, randomised Phase III trial of LPCN 1154 for PPD.
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