Medicus Pharma (NASDAQ:MDCX) has reached a critical regulatory milestone, submitting an optimized Phase 2 clinical trial protocol to the U.S. Food and Drug Administration (FDA) for its lead candidate, Teverelix, aimed at preventing recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia (BPH).
The proposed study is a multi-center, randomized, four-arm trial designed to evaluate the safety and efficacy of a single dose of Teverelix.
The company plans to enroll approximately 126 patients across clinical sites in the United States and Europe.
The study’s primary endpoint is a mechanism-driven measure: the percentage change in total prostate volume at Week 12.
The trial architecture includes a strategic interim analysis once approximately 50% of the patient cohort has completed the 12-week assessment.
This data checkpoint will allow Medicus Pharma to refine dose selection and the administration route for the remainder of the study.
The total study duration is set at 52 weeks, consisting of a 28-week treatment phase followed by a 24-week observational period.
Medicus Pharma is targeting a significant unmet need in the urology space.
Recurrent acute urinary retention is a painful and often emergency complication of BPH, and the company estimates the addressable market for AURr prevention to be approximately $2 billion.
Teverelix, a GnRH antagonist, is designed to rapidly reduce prostate volume, potentially offering a non-surgical alternative to long-term catheterization or invasive procedures.
The submission comes as Medicus Pharma continues to scale its clinical operations following its 2024 NASDAQ listing.
If the FDA grants clearance for the protocol, the company expects to begin patient screening in the second half of 2026.