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Lipocine doses first participant in Phase 3 BLOOM study of LPCN 1154 for postpartum depression
LPCNLipocine Inc.
Lipocine Inc. has dosed the first participant in the BLOOM Phase 3 clinical trial evaluating LPCN 1154, an oral formulation of brexanolone, for the treatment of postpartum depression. The placebo-controlled outpatient study is designed to enroll approximately 120 participants and will assess efficacy and safety using a 48-hour dosing regimen intended for at-home use. Topline results are expected in the second half of 2027. This trial incorporates design improvements based on feedback from the FDA and lessons learned from a prior Phase 3 study that did not meet its primary endpoint. Lipocine Inc. is a biopharmaceutical company developing oral therapeutics using proprietary drug-delivery technology.