PHILADELPHIA, July 16, 2026
Medicus Pharma announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) and Central Institutional Review Board (IRB) approval for its optimized Phase 2 ANT-2111-02 clinical trial evaluating Teverelix® in men following a first episode of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH). The redesigned study is intended to generate robust pharmacodynamic data while significantly improving development efficiency.
Optimized Trial Reduces Enrollment While Preserving Clinical Objectives
The randomized, double-blind, placebo-controlled, multicenter Phase 2 study has been redesigned to enroll approximately 126 patients, compared with the previously planned 390 participants. The streamlined trial will evaluate optimized intramuscular and subcutaneous Teverelix dosing regimens against placebo, with the goal of identifying the optimal dose and administration route while generating decision-grade clinical evidence to guide future development.
FDA Feedback Supports Study Advancement
The FDA provided seven recommendations focused on operational aspects of the study, including safety monitoring, protocol clarification, data collection, and endpoint wording. According to Medicus, the agency’s comments do not require changes to the study’s scientific rationale, patient population, treatment arms, primary endpoint, or planned interim analysis. The company plans to incorporate the recommendations into the final protocol while continuing preparations for study initiation.
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IRB Approval and Comprehensive Study Design Advance Development
Advarra, the study’s Central IRB, approved the ANT-2111-02 protocol with modifications through June 18, 2027, covering the clinical protocol, informed consent documents, investigator brochure, recruitment materials, and patient-reported outcome instruments. The study will evaluate reduction in total prostate volume as its primary endpoint while also assessing recurrent acute urinary retention, urinary flow rate, post-void residual volume, treatment failure, pharmacodynamic and endocrine biomarkers, safety, and durability of response. Medicus believes the integrated design will provide one of the most comprehensive Phase 2 datasets for Teverelix, supporting future regulatory discussions, late-stage clinical development, and potential strategic partnering opportunities.
Source: Medicus Pharma press release
