Medicus Pharma advances Teverelix Phase 2 study after FDA feedback, IRB approval
Published: 08:37 16 Jul 2026 EDT
Medicus Pharma (NASDAQ:MDCX) said it has received US FDA feedback and central Institutional Review Board approval for its optimized Phase 2 study of Teverelix in men following a first episode of acute urinary retention.
The redesigned study, designated ANT-2111-02, is expected to enroll approximately 126 patients across the United States and Europe, down from roughly 390 patients contemplated under the company's previously disclosed development plan.
The randomized, double-blind, placebo-controlled, multicenter trial will evaluate the pharmacodynamic effects of Teverelix DP, a long-acting gonadotropin-releasing hormone antagonist, on prostate volume and urinary function in men who have experienced a first episode of acute urinary retention.
"FDA's positive feedback and central IRB approval represent meaningful progress toward advancing our Teverelix Program," said Raza Bokhari, Medicus’s CEO.
"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."
The FDA provided seven comments on protocol implementation, safety monitoring and clarification. The company said the recommendations are operational in nature and do not require changes to the study's scientific rationale, patient population, treatment arms, primary endpoint or planned interim analysis.
Advarra, the study's central IRB, approved the protocol with modifications, with the approval period extending for one year. Each participating principal investigator and clinical site must still complete site-specific submissions and receive local authorization before initiating patient enrollment.
Medicus said it is working with its regulatory, clinical and contract-research partners to incorporate the FDA and IRB comments, finalize participating clinical sites and complete remaining study start-up activities.
Shares of Medicus added 8% on the update.
