Medicus Pharma wins FDA backing for optimized Phase 2 Teverelix study in acute urinary retention

Medicus Pharma wins FDA backing for an optimized Phase 2 Teverelix study in acute urinary retention. The company said it received written FDA feedback dated July 8, 2026, supporting the revised study design.

The protocol redesign cuts planned enrollment to about 126 patients from about 390, with the aim of generating an earlier pharmacodynamic signal.

ANT-2111-02 is a randomized, double-blind, placebo-controlled study of long-acting GnRH antagonist Teverelix DP via intramuscular and subcutaneous regimens. The primary endpoint targets reduction in total prostate volume, and the study will also track recurrent acute urinary retention and urinary function measures.

Central IRB Advarra cleared the protocol with modifications on June 18, 2026, supporting site activation and study start-up work.