Medicus Pharma (NASDAQ:MDCX) announced that it has received "study may proceed" clearance from the US Food and Drug Administration (FDA) to initiate a Phase 2b dose-optimization study of Teverelix, its investigational long-acting gonadotropin-releasing hormone (GnRH) antagonist, in men with advanced prostate cancer and elevated cardiovascular risk.
The open-label Phase 2b trial is expected to enroll 40 patients who are candidates for androgen deprivation therapy.
Participants will receive an initial loading regimen followed by maintenance dosing every six weeks over an approximately 22-week treatment period.
The primary endpoint is achieving and maintaining medical castration levels of testosterone, with sustained suppression through Day 155.
Teverelix is designed to provide rapid suppression of luteinizing hormone, follicle-stimulating hormone, and downstream sex hormones without the initial testosterone surge associated with GnRH agonists.
Medicus said the mechanism may be relevant for patients with cardiovascular risk, a population that can experience higher rates of adverse cardiovascular events during hormone therapy. The company noted that previous studies have not shown significant cardiovascular safety signals, though further validation is required.
The Phase 2b study will assess the durability and consistency of hormone suppression as well as cardiovascular safety, with the goal of supporting a potential registrational Phase 3 program.
Medicus said it has aligned with the FDA on a development indication focused on advanced prostate cancer patients with increased cardiovascular risk and has outlined a Phase 3 framework that would evaluate both castration efficacy and cardiovascular outcomes.
"[The] Teverelix Phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the Teverelix program," Medicus Pharma CEO Dr Raza Bokhari said in a statement.
"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."
In parallel, Medicus said it maintains a European clinical trial authorization framework for the program and views Teverelix as a potential candidate for strategic partnerships as development progresses.
The company also highlighted that it continues to advance its SkinJect microneedle platform delivering doxorubicin for basal cell carcinoma. Enrollment for its Phase 2 study has been completed, with topline data expected in the first quarter of 2026 and an end-of-Phase 2 FDA meeting planned for the first half of the year.
