PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) said it has received “study may proceed” clearance from the U.S. Food and Drug Administration to initiate a Phase 2b dose-optimization trial of Teverelix in men with advanced prostate cancer, as the company advances development of the investigational hormone therapy.
The company announced the clearance in a press release outlining plans for the open-label study, which will enroll 40 men with advanced prostate cancer who are appropriate candidates for androgen deprivation therapy.
Participants will receive a 540 mg loading regimen consisting of one 180 mg intramuscular injection and two 180 mg subcutaneous injections, followed by 360 mg administered subcutaneously on Day 29 and every six weeks thereafter. Total treatment duration is expected to be about 22 weeks.
The primary endpoint is confirmation of medical castration by Day 29 with sustained testosterone suppression through Day 155, with a target probability exceeding 90%.
Teverelix is a long-acting injectable gonadotropin-releasing hormone, or GnRH, antagonist formulated as a microcrystalline suspension. Unlike GnRH agonists, which can cause an initial surge in testosterone, antagonists are designed to suppress luteinizing hormone and follicle-stimulating hormone without a flare effect.
Medicus said the study will evaluate the durability of testosterone suppression, the degree and consistency of follicle-stimulating hormone suppression and cardiovascular safety. The company said the trial is intended to support a registrational Phase 3 pathway aligned with prior FDA guidance.
According to the release, cardiovascular disease accounts for about 30% of non-cancer deaths among men with prostate cancer, and the risk can increase during androgen deprivation therapy, particularly in patients with pre-existing cardiovascular conditions.
Medicus said Teverelix is being developed for patients with advanced prostate cancer and defined cardiovascular risk factors, including recent major adverse cardiovascular events or significant subclinical atherosclerosis.
The company stated that between 300,000 and 500,000 men in the United States are living with advanced prostate cancer.
In November 2025, Medicus said it aligned with the FDA on a development indication focused on hormone therapy for advanced prostate cancer patients with increased cardiovascular risk.
Separately, the company said it has completed enrollment in a Phase 2 study of SkinJect, a microneedle array platform delivering doxorubicin for basal cell carcinoma. Topline data from that study are expected in the first quarter of 2026, with an end-of-Phase 2 meeting with the FDA planned for the first half of 2026.
Medicus said it is advancing programs through Phase 2 development with the intention of pursuing licensing or strategic partnerships for later-stage development and commercialization.
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