Lipocine begins second pivotal trial of at-home postpartum depression therapy after earlier miss

Lipocine said on 10 November 2026 that it has given the first dose in BLOOM, a late-stage outpatient study of LPCN 1154, its oral version of brexanolone for postpartum depression. The drug is taken over two days, and patients can use it at home. The trial is placebo-controlled and is planned to enrol about 120 participants.

The study is a second attempt. An earlier Phase 3 trial of the same candidate failed to reach its main goal. Lipocine says BLOOM's design draws on feedback from the US Food and Drug Administration.

According to the company, that feedback means one successful, well-controlled Phase 3 study would still be enough to back a 505(b)(2) application. That US pathway lets a sponsor lean partly on data it did not produce itself, such as established findings for an already approved drug. Lipocine has not disclosed a filing timetable or any commercial terms in this announcement.

Headline results are expected in the second half of 2027. Until then, the at-home, short-course positioning remains a development-stage proposition, and the programme's regulatory route hinges on the outcome of this single trial.