Medicus Pharma has filed an optimized Phase 2 clinical study design with the FDA under its existing IND for Teverelix to prevent recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia (BPH). The submission, led by Principal Investigator Dr. Steven A. Kaplan, emphasizes capital efficiency and accelerated data generation to support early strategic engagement.

The randomized, double-blind, single-dose, four-arm trial will enroll approximately 126 patients across the U.S. and Europe, representing a three-fold reduction in size from the original design. Primary endpoint is percent change in total prostate volume at week 12, with secondary measures including urine flow rate, post-void residual volume, AURr incidence and intervention need. An interim analysis after 50% of patients complete week 12 will inform dose selection and route optimization.

By focusing on clear pharmacodynamic endpoints and a leaner trial structure, the company expects meaningful cost savings and faster data readouts within 12 weeks. This approach is intended to enhance Medicus’s ability to attract partners and advance Teverelix toward commercialization in a potential $2 billion preventive market for AUR recurrence.