Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Medicus Pharma Ltd. announced it has submitted an optimized Phase 2 clinical study design to the U.S. Food and Drug Administration for teverelix, an investigational gonadotropin-releasing hormone (GnRH) antagonist, for the prevention of recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia (BPH). The submission was made under the company’s existing open Investigational New Drug (IND) application.
The revised Phase 2 design was developed under the leadership of Steven A. Kaplan, who will serve as principal investigator. Kaplan is Professor of Urology at the Icahn School of Medicine at Mount Sinai and is recognized for his work in benign prostatic hyperplasia and lower urinary tract symptoms, with prior academic roles at Columbia University and Weill Cornell Medical College.
According to Executive Chairman and CEO Raza Bokhari, the refined study design aims to improve capital efficiency and accelerate clinical development. The company stated that focusing on pharmacodynamic endpoints and incorporating an interim analysis could enable earlier generation of actionable clinical data and support future development decisions and potential partnering discussions.
There are currently no approved pharmacologic therapies specifically indicated to prevent recurrence of acute urinary retention caused by enlarged prostate. Medicus said its proof-of-concept evaluation of teverelix in AURr is intended to address this unmet clinical need, which the company estimates represent an approximately $2 billion market opportunity.
Phase 2 Study Design
The updated Phase 2 study (ANT-2111-02) will enroll approximately 126 patients across the United States and Europe and is designed to detect a clear pharmacodynamic signal based on total prostate volume reduction while differentiating dose and route of administration. The company stated that the optimized design represents roughly a three-fold reduction in sample size compared with the original plan, with lower development costs and faster execution, and is expected to generate an early pharmacodynamic signal within about 12 weeks. The randomized, double-blind, single-dose, four-arm trial will evaluate teverelix 90 mg administered intramuscularly, teverelix 120 mg administered subcutaneously, and matched placebo controls.
All patients will receive a single injection on Day 1 and remain on standard-of-care alpha-blocker therapy. The total study duration is 52 weeks, including a 28-week treatment period and a 24-week follow-up.
The primary endpoint is percent change in total prostate volume at Week 12. Secondary endpoints include maximum urine flow rate (Qmax), post-void residual volume (PVR), recurrence of acute urinary retention, and need for intervention.
An interim analysis will be conducted after approximately 50% of participants complete the Week 12 assessment. The analysis is intended to inform dose selection, route optimization, and future Phase 3 study design while providing an early pharmacodynamic signal to guide development decisions.
Reference
Medicus Pharma Submits Optimized Phase 2 Study Protocol to U.S. FDA for Teverelix in Acute Urinary Retention, 06 April 2026, https://medicuspharma.com/medicus-pharma-submits-optimized-phase-2-study-protocol-to-u-s-fda-for-teverelix-in-acute-urinary-retention/
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.