Medicus Pharma Chief Medical Officer Dr Faisal Mehmud joined Steve Darling from Proactive to announce that the company has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration for Teverelix. The therapy is being developed to help prevent recurrent acute urinary retention (AUR) in men with benign prostatic hyperplasia (BPH) under the company’s existing open Investigational New Drug application.

Mehmud explained that the updated study design has been refined under the leadership of Steven A. Kaplan, MD, FACS, a globally recognized expert in urology and men’s health, who will serve as Principal Investigator.

He noted that there are currently no approved pharmacological therapies specifically indicated to prevent the recurrence of AUR, which is most caused by an enlarged prostate. Medicus Pharma’s proof-of-concept approach for Teverelix aims to address this unmet need, targeting a market estimated at approximately $2 billion.

The revised Phase 2 study design, known as ANT-2111-02, includes a targeted sample size of approximately 126 patients across sites in the United States and Europe. The study is designed to detect a clear pharmacodynamic signal, specifically total prostate volume reduction, within an expected timeframe of about 12 weeks.

The optimized design reflects a data-driven approach, reducing the study size by roughly threefold compared to the original plan. This adjustment is expected to significantly lower development costs while improving efficiency and execution speed. The streamlined approach also positions the company for earlier strategic engagement and potential partnering discussions.

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