Lipocine Doses First Participant in BLOOM Phase 3 Study of LPCN 1154 for Postpartum Depression
Key Highlights
- ➤Lipocine (LPCN) dosed first participant in BLOOM Phase 3 postpartum depression study
- ➤BLOOM plans approximately 120 participants using a 48-hour oral at-home treatment regimen
- ➤Topline BLOOM results expected in 2H 2027
- ➤Prior Phase 3 trial missed its primary endpoint in the full analysis set
- ➤FDA says one positive, well-controlled Phase 3 trial remains needed for 505(b)(2) NDA submission
Expert Statements
Mahesh Patel, President and Chief Executive Officer of Lipocine
“Our goal is to develop a treatment that provides rapid symptom relief through a 48-hour oral course taken at home.”
Mahesh Patel, President and Chief Executive Officer of Lipocine
“We believe the BLOOM Phase 3 study is designed to promote study enrollments that are representative of the actual patient population of postpartum depression and provide confidence in data quality.”
Lipocine Doses First Participant in BLOOM Phase 3 Study of LPCN 1154 for Postpartum Depression PR Newswire
* LPCN 1154 is being developed as a 48-hour oral treatment intended for at-home use in postpartum depression * Approximately 120 participants planned for the study, which incorporates insights from the previous Phase 3 trial to promote site and data quality * Topline results from BLOOM study are expected in 2H 2027 SALT LAKE CITY, Nov. 10, 2026 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company focused on the development of novel oral therapeutics, today announced that the first participant has been dosed in BLOOM, the Company's Phase 3 study evaluating LPCN 1154 (oral brexanolone) for postpartum depression (PPD). LPCN 1154 is being developed as a 48-hour oral treatment intended for at-home use.
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