Teverelix (ANT-2111-02) - (AURr)

July 16, 2026: Medicus Pharma Ltd. (NASDAQ: MDCX) announced it received written FDA feedback (dated July 8, 2026) and central IRB approval (with modifications) for its optimized Phase 2 trial of Teverelix® in men after a first episode of acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH).

Teverelix / ANT-2111-02 (Phase 2; AUR recurrence prevention): The randomized, double-blind, placebo-controlled, multicenter study will evaluate Teverelix DP (long-acting GnRH antagonist) versus placebo, including optimized intramuscular and subcutaneous regimens. Planned enrollment is ~126 patients across the U.S. and Europe (reduced from ~390 previously contemplated). Primary endpoint is reduction in total prostate volume; additional assessments include recurrent AUR, urinary function (Qmax and PVR), treatment failure/need for BPH intervention, and pharmacodynamic/endocrine/safety measures. A pre-specified interim analysis is intended to inform dose and route selection.

Regulatory/ethics milestones: FDA provided seven implementation/monitoring/clarification recommendations (e.g., contraception reporting alignment, maintaining blinding for injection-site assessments, capturing race, endpoint wording). Medicus said these are operational and do not change key scientific elements. Advarra approved the protocol June 18, 2026 through June 18, 2027; site-level authorizations are still required before enrollment. Medicus said it will update timing guidance after incorporating feedback and completing start-up activities.