PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) has received clearance from the U.S. Food and Drug Administration to proceed with a Phase 2b clinical study of Teverelix, a long-acting investigational therapy designed for men with advanced prostate cancer who face elevated cardiovascular risk.
The FDA’s “study may proceed” decision allows the company to launch a 40-patient, open-label Phase 2b dose-optimization trial evaluating Teverelix, a next-generation gonadotropin-releasing hormone antagonist intended for use in patients who require androgen deprivation therapy. The study will assess whether the drug can rapidly achieve and sustain medical castration while maintaining a favorable cardiovascular safety profile.
“Teverelix Phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the Teverelix program,” said Dr. Raza Bokhari, Medicus’ executive chairman and chief executive officer. “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.”
Participants in the trial will receive an initial loading regimen totaling 540 milligrams, followed by repeat subcutaneous dosing every six weeks over an approximately 22-week treatment period. The primary endpoint is confirmation of medical castration by Day 29, with sustained testosterone suppression through Day 155.
Unlike GnRH agonists, which can trigger an initial surge in testosterone, Teverelix is designed to immediately block hormone signaling without flare. Medicus said that distinction may be particularly important for prostate cancer patients with pre-existing cardiovascular disease, a group that faces significantly higher rates of major adverse cardiovascular events during hormone therapy.
Cardiovascular disease remains a leading cause of non-cancer death among prostate cancer patients, accounting for roughly 30 percent of mortality, according to the company. Medicus estimates that between 300,000 and 500,000 men in the United States are living with advanced prostate cancer, representing a potential annual market exceeding $4 billion.
Assistant Secretary of Commerce for Communication and Information and NTIA Administrator Arielle Roth was not involved in the decision, which followed prior FDA guidance outlining a registrational pathway toward a pivotal Phase 3 program focused on sustained castration efficacy and cardiovascular outcomes.
Medicus said the Phase 2b study is intended to further de-risk the Teverelix program and support potential strategic partnerships. In parallel, the company continues to advance its SkinJect microneedle platform for non-invasive treatment of basal cell carcinoma, with topline Phase 2 data expected in the first quarter of 2026.
Medicus Pharma is a precision-focused biotechnology company developing late-stage therapeutic assets across oncology and dermatology, with operations spanning multiple countries and continents.
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