Lipocine announced the completion of the second interim safety review in the Phase 3 trial of LPCN 1154 for postpartum depression.
No drug-related serious adverse events reported in the study with 82 randomized participants.
Enrollment of new participants meeting eligibility criteria is ongoing, with topline results expected in Q2 2026.
Safety Validation
No drug discontinuations, excessive sedation, or loss of consciousness reported in the trial.
DSMB Recommendation
The Data Safety Monitoring Board recommended continuation of the trial without modification.
Upcoming Milestone
Topline safety and efficacy results are planned to be reported in early Q2 2026.
Treatment Potential
LPCN 1154 shows promise as an effective and safe treatment for postpartum depression.
- The positive safety data reinforces confidence in LPCN 1154's potential as a treatment for PPD.
- Enrollment of additional participants indicates ongoing progress in the Phase 3 trial.
Lipocine's Phase 3 trial progress marks a significant step towards providing a new treatment option for postpartum depression, potentially addressing unmet medical needs in this area.