Lipocine Inc. announced 80% completion of enrollment in the Phase 3 clinical trial for LPCN 1154.
The trial evaluates LPCN 1154 for the rapid relief treatment of Postpartum Depression (PPD).
Second Drug Safety Monitoring Board meeting update is planned for mid-January 2026.
Enrollment Milestone Reached
80% enrollment milestone achieved in the Phase 3 trial evaluating LPCN 1154 for PPD.
DSMB Meeting Update
Second Drug Safety Monitoring Board meeting update scheduled for mid-January 2026.
Topline Results
Topline results for LPCN 1154 on track to be announced in the second quarter of 2026.
- The encouraging recruiting rate reflects potential unmet medical needs in the treatment of PPD.
- DSMB recommended continuation of the trial without modification after the first review.
- Data from the Phase 3 trial set to support a 505(b)(2) NDA submission for LPCN 1154 in 2026.
Lipocine's progress in the Phase 3 trial indicates promising outcomes in addressing the challenges of PPD treatment. The upcoming DSMB meeting and the anticipated topline results are crucial milestones for the company's development pipeline.