Lipocine doses first participant in Phase 3 trial of LPCN 1154 for postpartum depression
LPCN•Lipocine dosed the first participant in BLOOM, a Phase 3 trial of LPCN 1154 for postpartum depression. The trial plans to enroll about 120 participants, with topline results expected in the second half of 2027.
1. BLOOM trial begins
Lipocine said it dosed the first participant in BLOOM, a placebo-controlled outpatient Phase 3 trial of oral brexanolone treatment LPCN 1154 for postpartum depression. The planned treatment is a 48-hour course for at-home use, and the trial plans to enroll approximately 120 participants, with topline results expected in the second half of 2027.
2. Further evaluation
A previous Phase 3 trial missed its primary endpoint, while safety outcomes and exploratory findings supported further evaluation. BLOOM incorporates tighter study controls following FDA feedback, aiming to support a potential New Drug Application.
