Medicus Pharma Submits Optimised Phase 2 Trial Design For Teverelix To Address Unmet Need In BPH-Related Urinary Retention

Medicus Pharma Ltd. has announced the submission of an optimized Phase 2 clinical trial design to the U.S. Food and Drug Administration for Teverelix, its investigational GnRH antagonist. The study aims to evaluate the drug’s potential in preventing recurrent acute urinary retention (AURr) in men suffering from benign prostatic hyperplasia (BPH), under the company’s existing Investigational New Drug (IND) application.

The revised trial design has been developed under the guidance of Steven A. Kaplan, a globally recognized authority in urology and men’s health, who will serve as Principal Investigator. His extensive experience in BPH and urinary disorders is expected to support the clinical development strategy and strengthen the study’s scientific foundation.

“This refined study design reflects a more capital-efficient development strategy intended to accelerate Teverelix’s path to commercialization,” said Dr. Raza Bokhari, Executive Chairman and CEO of Medicus. “By focusing on clear pharmacodynamic endpoints and incorporating an interim analysis designed to inform subsequent clinical development, we believe Teverelix can generate actionable clinical data more rapidly, enabling earlier strategic engagement and potential partnering opportunities.”

Currently, there are no approved drug therapies specifically indicated to prevent the recurrence of acute urinary retention caused by prostate enlargement. Medicus’ approach with Teverelix aims to address this unmet medical need, targeting a market opportunity estimated at around $2 billion. The study is designed to assess key pharmacodynamic outcomes, particularly reductions in total prostate volume.

The updated Phase 2 design includes approximately 126 patients across the United States and Europe and focuses on identifying clear dose-response relationships while improving efficiency. Compared to earlier plans, the optimized design significantly reduces trial size and development costs, while enabling faster execution. The study is expected to deliver early pharmacodynamic insights within approximately 12 weeks, supporting quicker decision-making and potential partnership opportunities.