FDA Clears Phase 2b Study of Teverelix in Advanced Prostate Cancer

The U.S. Food and Drug Administration (FDA) has granted “study may proceed” clearance for a phase 2b clinical trial evaluating teverelix, an investigational hormone therapy for men with advanced prostate cancer who also face a high risk of cardiovascular disease, according to a news release from Medicus Pharma Ltd. The clearance allows the company to move forward with dose optimization testing of the drug, which is designed to suppress testosterone without triggering the hormone surge associated with some existing therapies.

Advanced prostate cancer is commonly treated with androgen deprivation therapy (ADT), which lowers testosterone levels to slow disease progression. However, many standard hormone therapies can increase cardiovascular risk, an important concern because heart disease remains a leading cause of death among men with prostate cancer. Teverelix is being developed specifically to address this unmet need by offering effective hormone suppression with a potentially more favorable cardiovascular safety profile.

“Teverelix phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the teverelix program,” stated Dr. Raza Bokhari, chairman and CEO of Medicus Pharma Ltd. “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.”

Key Goals of the Phase 2b Teverelix Study

The phase 2b study is an open-label trial that will enroll 40 men with advanced prostate cancer who are appropriate candidates for ADT. Participants will receive an initial loading dose of teverelix followed by maintenance dosing every six weeks, with total treatment lasting approximately 22 weeks.

The primary goal of the study is to confirm medical castration, defined as suppression of testosterone to very low levels, by Day 29 and to maintain that suppression through Day 155. Investigators are targeting a success rate exceeding 90%, which would support further development of the therapy.

In addition to testosterone suppression, the study will closely evaluate the durability and consistency of follicle-stimulating hormone (FSH) suppression, as well as overall cardiovascular safety. These data are expected to help inform the design of a future phase 3 trial intended to support regulatory approval.

Why Cardiovascular Risk Matters in Advanced Prostate Cancer

Cardiovascular disease accounts for approximately 30% of non-cancer deaths among men with prostate cancer, and the risk may increase during hormone therapy. Some commonly used treatments, known as gonadotropin-releasing hormone (GnRH) agonists, can cause an initial surge in testosterone before levels fall, as well as ongoing exposure to FSH. Emerging evidence suggests these effects may contribute to cardiovascular complications, particularly in patients with pre-existing heart disease.

Teverelix is a next-generation, long-acting GnRH antagonist. Unlike GnRH agonists, it works by immediately blocking the GnRH receptor, leading to rapid suppression of luteinizing hormone, FSH, and testosterone without an initial flare. This mechanism may be especially important for patients with advanced prostate cancer who have a history of major adverse cardiovascular events or severe underlying atherosclerosis.

Although further validation is needed, prior studies of teverelix have not shown significant cardiovascular safety concerns to date.

How the Teverelix Study Is Being Conducted

The phase 2b trial uses a dose-optimization design to determine the most effective and durable dosing schedule. Patients will receive an initial combination of intramuscular and subcutaneous injections, followed by repeat subcutaneous doses every six weeks.

Researchers will monitor hormone levels, safety outcomes and cardiovascular markers throughout the study. The goal is to generate decision-grade data that can support a registrational phase 3 program aligned with prior FDA guidance.
Medicus has indicated that the study is designed to create a clear pathway toward a pivotal trial evaluating both cancer control and cardiovascular outcomes.

Who May Benefit From Teverelix

The therapy is being developed for a specific subset of patients with advanced prostate cancer who also have objectively defined cardiovascular risk. This includes men with a recent history of major cardiovascular events or evidence of severe subclinical heart disease, such as a high coronary artery calcium score combined with elevated atherosclerotic cardiovascular disease risk.

An estimated 300,000 to 500,000 men in the United States are living with advanced prostate cancer, representing a substantial patient population with diverse treatment needs. For patients in whom cardiovascular safety plays a critical role in treatment decisions, therapies like teverelix could offer a new option.

References

1. “Medicus Pharma Receives FDA “Study May Proceed” Clearance For Teverelix® Phase 2b Study in Advanced Prostate Cancer Patients with High Cardiovascular Risk,” by Medicus Pharma Ltd. News release; Feb. 10, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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