Lipocine Nears Full Enrollment In Phase 3 PPD Trial, Topline Results Expected Q2 2026

Benzinga · 1d ago
  • Second Drug Safety Monitoring Board (DSMB) meeting update planned for mid-January 2026
  • Topline results on track for the second quarter of 2026

SALT LAKE CITY, Dec. 16, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, today announced 80% completion of enrollment in the ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD, with 66 of the 80 planned study participants randomized. In addition, the second of two independent Data Safety Monitoring Board reviews is planned for early-January 2026. Following the first DSMB review, the board recommended that the trial continue as planned without modification.