FDA Greenlights Medicus’ Phase 2b Study Of Teverelix, A Next-Generation GnRH Antagonist For Advanced Prostate Cancer

Medicus Pharma has secured clearance from the U.S. Food and Drug Administration to launch a Phase 2b dose-optimization trial of Teverelix, its investigational long-acting GnRH antagonist, in men with advanced prostate cancer. The open-label study will enroll 40 patients eligible for androgen deprivation therapy and is designed to confirm rapid and sustained testosterone suppression while closely monitoring cardiovascular safety. The program reflects the company’s strategy to develop differentiated oncology therapies for patient groups with high unmet medical need.

Participants will receive a loading regimen combining intramuscular and subcutaneous injections, followed by maintenance dosing every six weeks for about 22 weeks. The main goal is to achieve medical castration by Day 29 and maintain it through Day 155 with a success rate above 90%. Additional evaluations will examine durability of hormone suppression, consistency of follicle-stimulating hormone control, and overall safety, forming the basis for a future registrational Phase 3 program.

“Teverelix Phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the Teverelix program,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO, “Our development strategy is intentionally focused on a population that remains underserved by existing therapies. If successful, we believe Teverelix has the potential to become a best-in-class GnRH antagonist and the first hormone therapy specifically supported by a Cardiovascular-risk-focused label in this setting.”

Teverelix is formulated as a microcrystalline injectable GnRH antagonist that avoids the testosterone surge typically seen with GnRH agonists. This mechanism may be particularly important for patients with elevated cardiovascular risk, a group that experiences higher rates of adverse cardiac events during standard hormone therapy. Medicus is specifically targeting men with recent major cardiovascular events or severe underlying atherosclerosis, aiming to position Teverelix as a best-in-class option in this segment.

The company estimates that hundreds of thousands of men in the U.S. live with advanced prostate cancer, representing a multibillion-dollar commercial opportunity. With U.S. and European regulatory pathways already outlined, Medicus believes Teverelix is increasingly attractive for strategic partnerships and could emerge as a cornerstone therapy for prostate cancer patients where cardiovascular safety strongly influences treatment decisions.