(RTTNews) - Medicus Pharma Ltd. (MDCX), a clinical-stage biopharmaceutical company, announced that it has submitted an optimized Phase 2 study protocol to the U.S. FDA for Teverelix, its lead candidate in the treatment of acute urinary retention.
Acute urinary retention (AURr) is a sudden inability to urinate, often linked to benign prostatic hyperplasia (BPH), and can severely impact quality of life. Current management typically involves catheterization, which is invasive and uncomfortable. Teverelix, a novel GnRH antagonist, is being developed as a potential non-surgical therapeutic option to address this unmet need.
The optimized Phase 2 study, designated ANT-2111-02, will enroll 126 patients. The trial is designed to generate an early pharmacodynamic signal within approximately 12 weeks. The overall study duration is 52 weeks, including a 28-week treatment period followed by a 24-week observation period to assess long-term outcomes. Teverelix dosing will include 90 mg intramuscular and 120mg subcutaneous regimens, evaluated for its ability to reduce catheterization rates and improve urinary function.
"We are pleased to advance Teverelix into its next stage of clinical development with this FDA submission," said Medicus Pharma's management team. "This represents an important step toward providing patients with a new, less invasive treatment option for acute urinary retention."
The company emphasized that the submission reflects its commitment to addressing urological disorders with innovative therapies. Teverelix has already demonstrated promising results in earlier studies, showing potential to rapidly restore urinary function.
Medicus Pharma estimates the market opportunity for $6 billion, underscoring the commercial potential of Teverelix.
MDCX has traded between $0.37 and $8.94 over the past year. The stock closed Thursday's trading (April 2, 2026) at $0.44, up 6.43%. In pre-market the stock is at $0.44, down 1.01%.
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