Regulatory and ethical-review milestones advance a capital-efficient Phase 2 study expected to enroll ~126 patients versus ~390 under the previously disclosed development plan
PHILADELPHIA, July 16, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, today announced that it has received written feedback from the U.S. Food and Drug Administration ("FDA") and central Institutional Review Board ("IRB") approval, with modifications, for its optimized Phase 2 clinical study of Teverelix® in men following a first episode of acute urinary retention ("AUR").
The randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, is a novel study designed to evaluate the pharmacodynamic effects of Teverelix DP, a long-acting gonadotropin-releasing hormone ("GnRH") antagonist, on prostate volume and urinary function in men following a first episode of AUR.
The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing Investigational New Drug ("IND") application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development.
"FDA's positive feedback and central IRB approval represent meaningful progress toward advancing our Teverelix Program," stated Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "Acute urinary retention is a serious and distressing complication frequently associated with benign prostatic hyperplasia. By redesigning this study, we believe we have transformed the Teverelix development program into a substantially more efficient clinical strategy, reducing anticipated enrollment from approximately 390 patients to approximately 126 patients while preserving our ability to generate decision-grade clinical evidence. We believe this approach has the potential to accelerate clinical development, optimize capital allocation and generate the robust dataset needed to inform future FDA interactions, subsequent late-stage development, potential strategic partnering opportunities, and ultimately improve outcomes for patients suffering from this significant unmet medical need."