Lipocin completes section III enrollment for LPCN 1154 in PPD
Lipocine has introduced the completion of enrollment and dosing of individuals in its Part III scientific trial investigating LPCN 1154, an oral formulation of brexanolone, for the remedy of postpartum melancholy (PPD).
The trial, aimed toward ladies aged 15 years and older identified with extreme PPD, randomized 90 sufferers to obtain LPCN 1154 or a placebo.
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LPCN 1154 has demonstrated a good security profile so far. No instances of extreme sedation, drug discontinuation, drug-related severe antagonistic occasions (SAEs), or lack of consciousness had been noticed amongst individuals.
The double-blind, randomized section III examine is being performed solely on an outpatient foundation. It obtained constructive suggestions from the US Meals and Drug Administration (FDA).
Lipocine famous that administration of LPCN 1154 doesn’t require medical supervision by a healthcare supplier. Knowledge from this examine is anticipated to help a 505(b)(2) new drug utility in 2026.
LPCN 1154 is designed to supply speedy reduction from PPD with handy remedy at dwelling. It may gain advantage people with extreme PPD, particularly these at greater danger of suicide, for whom speedy enchancment is important.
PPD is a depressive dysfunction during which signs start throughout being pregnant or inside 4 weeks after supply and sometimes final for as much as twelve months after supply.
Lipocine CEO Mahesh Patel stated: “We stay up for reporting prime security and efficacy ends in early Q2 2026.”
Lipocine’s pipeline contains candidates focusing on depressive issues, epilepsy, weight problems administration, important tremor, prevention of preterm labor, liver cirrhosis signs and an FDA-approved oral testosterone product.
In June 2025, the corporate initiated dosing to topics in its two-arm, blinded, randomized Part III trial of LPCN 1154 for PPD.
