Medicus Pharma Ltd. (NASDAQ: MDCX) submitted a substantial modification application through the European Union Clinical Trials Information System to support a planned Phase 2b study of Teverelix in advanced prostate cancer patients with elevated cardiovascular risk.

The submission supports the company's plan to initiate the Phase 2b study in 2026. The study targets prostate cancer patients requiring androgen deprivation therapy who have elevated cardiovascular risk, representing what the company estimates as a $4 billion annual market opportunity.

"Cardiovascular disease remains one of the most significant challenges facing men undergoing androgen deprivation therapy," stated Dr. Raza Bokhari, Medicus' Executive Chairman and CEO. "We believe Teverelix's unique pharmacologic profile, including flare-free rapid testosterone suppression, profound follicle-stimulating hormone suppression and a long-acting depot formulation, may offer meaningful advantages for this patient population."

Teverelix is a long-acting GnRH antagonist designed to provide rapid testosterone suppression without causing testosterone flare, along with follicle-stimulating hormone suppression through a depot formulation. The company has engaged with the U.S. Food and Drug Administration regarding its advanced prostate cancer development strategy.

The planned Phase 2b study aims to optimize dose selection and characterize the drug's pharmacokinetic, pharmacodynamic, efficacy and safety profile before registrational development. Subject to regulatory review and authorization, Medicus intends to begin patient enrollment later this year.

According to the company, approximately 20% to 60% of advanced prostate cancer patients have underlying cardiovascular disease, and about 30% of patients requiring androgen deprivation therapy have elevated cardiovascular risk. Currently, no hormonal therapy carries a regulatory label specifically addressing treatment of high cardiovascular-risk prostate cancer patients.