Enrollment and participant dosing have been accomplished within the part 3 scientific trial evaluating LPCN 1154 (oral brexanolone) for postpartum melancholy, Lipocine introduced.1 The drug has demonstrated a positive security profile up to now.
Presently, a complete of 90 sufferers have been randomized within the examine, which is a double-blind, placebo-controlled part 3 trial.2 The drug is being evaluated for girls aged 15 years or older who’ve been identified with extreme postpartum melancholy. Administration is being carried out solely in outpatient settings and administration doesn’t require medical monitoring by a healthcare supplier. This administration technique was based mostly on constructive suggestions from the US Meals and Drug Administration (FDA). Change from baseline in Hamilton Despair Ranking Scale rating in contrast with placebo would be the major endpoint measure. The trial’s secondary outcomes embody adjustments in Hamilton Despair Ranking Scale scores, Affected person World Impression Change scale response, Montgomery-Asberg Despair Ranking Scale rating, and Hamilton Nervousness Ranking Scale rating.
Sufferers included within the examine are females between ages 15 and 45 who’ve had a depressive episode that started no sooner than the threerd trimester and later than the primary 4 weeks following supply.2 Members have been lower than 12 months postpartum at screening and had a Hamilton Despair Ranking Scale 17-item rating indicating extreme melancholy. People with a historical past of bipolar dysfunction, schizophrenia, or schizoaffective dysfunction; who have been actively experiencing psychosis; had a historical past of suicidal habits within the final yr; or had a historical past of seizure within the final 6 months have been excluded from the examine.
LPCN 1154 has thus far demonstrated a positive security profile, with no experiences of drug discontinuations, extreme sedation, lack of consciousness, or drug-related severe adversarial occasions.
“We stay up for reporting topline security and efficacy outcomes early within the second quarter of 2026,” mentioned Mahesh Patel, PhD, chief govt officer of Lipocine, in a press launch. Patel added in a earlier press assertion, “We consider LPCN 1154’s goal profile, together with superior tolerability, fast therapeutic profit, and a brief 48-hour therapy course, has the potential to ascertain a brand new and improved therapy paradigm for PPD.”3
LPCN 1154 is an oral formulation of brexanolone presently in growth for fast reduction of postpartum melancholy in a extra handy, at dwelling surroundings. Lipocine famous the drug has potential to be a primary line therapy choice for girls with postpartum melancholy. Sufferers needing fast symptom reduction, like these with elevated suicide danger, may gain advantage notably from this medicine, the corporate mentioned. Present therapy choices have extra delayed onset and considerations with tolerability, which this medicine could supply an enchancment upon.
The part 3 trial is now not screening new individuals however is continuous enrollment for sufferers already having met eligibility standards. Section 3 trial knowledge are anticipated to help a 505(b)(2) New Drug Utility for LPCN 1154 in 2026.
References
1. Lipocine declares completion of enrollment and dosing in part 3 trial of LPCN 1154 in postpartum melancholy. Press launch. January 20, 2026. Accessed January 20, 2026.
2. A examine to evaluate the protection and efficacy of oral LPCN 1154A in girls with extreme PPD. ClinicalTrials.gov. September 2025. Accessed January 20, 2026.
3. Lipocine experiences encouraging progress submit second interim security overview in part 3 trial of LPCN 1154 in postpartum melancholy. Press launch. January 12, 2026. Accessed January 20, 2026.