Medicus Pharma received FDA feedback and IRB approval for its optimized Phase 2 ANT-2111-02 trial evaluating Teverelix in men with acute urinary retention secondary to benign prostatic hyperplasia.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Medicus Pharma has advanced the clinical development of Teverelix, its long-acting gonadotropin-releasing hormone (GnRH) antagonist, after receiving written feedback from the U.S. Food and Drug Administration (FDA) and modified approval from a central Institutional Review Board (IRB) for an optimized Phase 2 study in men experiencing a first episode of acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH).
The randomized, double-blind, placebo-controlled, multicenter Phase 2 ANT-2111-02 trial will evaluate Teverelix in approximately 126 patients across the United States and Europe, a substantial reduction from the previously planned 390 patients. Medicus said the redesigned study aims to generate early pharmacodynamic data while supporting dose optimization, route selection, and future clinical development.
FDA Feedback Supports Trial Initiation
The FDA reviewed the optimized protocol submitted under the existing Investigational New Drug (IND) application and issued written feedback on July 8, 2026. The agency provided seven recommendations related to safety monitoring, protocol implementation, and documentation, including contraception reporting, injection-site assessments, alpha-blocker use, demographic data collection, and clarification of a secondary endpoint.
Medicus said the recommendations are operational and do not require changes to the study design, treatment arms, patient population, primary endpoint, or planned interim analysis.
The study also received modified approval from Advarra, the central IRB, covering the clinical protocol, investigator brochure, informed consent documents, recruitment materials, and patient-reported outcome instruments. Individual clinical sites must still obtain site-specific authorization before enrolling participants.
Study Evaluates Prostate Volume and Urinary Function
ANT-2111-02 will compare optimized intramuscular and subcutaneous Teverelix regimens with matched placebo in men following a first episode of AUR caused by BPH.
The primary endpoint is reduction in total prostate volume. Secondary assessments include recurrent AUR, maximum urinary flow rate (Qmax), post-void residual volume (PVR), treatment failure, BPH-related medical or surgical intervention, endocrine effects, safety, and durability of response. A pre-specified interim analysis will support dose and administration route selection for later-stage development.
Path Forward
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus Pharma, said the optimized protocol improves development efficiency by reducing enrollment while preserving the ability to generate clinically meaningful evidence for future regulatory discussions and late-stage development.
The company is incorporating FDA and IRB recommendations, finalizing clinical sites, and completing study start-up activities before initiating enrollment. Teverelix has previously been evaluated in more than 400 patients across multiple clinical studies and is also under development for advanced prostate cancer and selected women’s health indications.
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About the Writer
Samiksha Vikram Jadhav (LinkedIn) is a B. Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She specializes in pharma market research, with a focused interest in mergers and acquisitions, strategic partnerships, and global pharma and biotech deals. Her work centers on analyzing industry transactions, market positioning, and business strategies, translating complex developments into clear, accurate, and insightful scientific and commercial reporting.