Lipocine initiates BLOOM Phase 3 trial of LPCN 1154 oral brexanolone for postpartum depression
LPCN•Prior study and funding
A prior Phase 3 study missed its primary endpoint overall, though post hoc analyses excluding one site suggested symptom improvement.
Management expects existing resources to fund the study, citing about USD 23.3 million cash as of June 30, 2026.
BLOOM Phase 3 trial initiated
Lipocine initiated the BLOOM Phase 3 trial of LPCN 1154, an oral brexanolone, as a 48-hour at-home treatment for severe postpartum depression.
First participant dosing is expected in early Q4 2026, with about 120 participants planned.
No new results were presented; BLOOM is designed to generate future efficacy and safety evidence for a potential 505(b)(2) NDA.
