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Medicus Pharma Receives FDA “Study May Proceed” Clearance For Teverelix® Phase 2b Study in Advanced Prostate Cancer Patients with High Cardiovascular Risk
The Company is developing Teverelix® as a best-in-class market product for advanced prostate cancer patients with high CV risk and a first in class product
About this update from Medicus Pharma Ltd.
[{"type":"text","content":"The Company is developing Teverelix® as a best-in-class market product for advanced prostate cancer patients with high CV risk and a first in class product for Acute Urinary Retention Relapse prevention (AURr) collectively representing ~US$6 billion in potential market opportunity\nPHILADELPHIA, Feb. 10, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (\"Medicus\" or the \"Company\"), a precision guided biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that it has received “study may proceed” clearance from the U.S. Food and Drug Administration (FDA) to initiate its Phase 2b dose-optimization study of Teverelix®, an investigational next generation long-acting GnRH antagonist, in men with advanced prostate cancer (APC). Teverelix® Clinical Trial Design in Advanced Prostate Cancer The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer appropriate for androgen deprivation therapy (ADT). Participants will receive: A loading regimen of 180 mg intramuscular (IM) plus two 180 mg subcutaneous (SC) injections (total 540 mg), followed byTwo 180 mg SC injections (360 mg total) on Day 29 and every six weeks thereafter Total treatment duration is approximately 22 weeks. The primary endpoint is confirmation of medical castration by Day 29 with sustained suppression through Day 155, with a target probability exceeding 90%. “Teverelix Phase 2 dose optimization study in advanced prostate cancer represents an important transition point for the Teverelix program,” stated Dr. Raza Bokhari, Medicus Exec. Chairman & CEO, “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.” Teverelix®: Differentiated Mechanism with Cardiovascular Relevance Teverelix trifluoroacetate is a long-acting injectable GnRH antagonist formulated as a microcrystalline suspension. Unlike GnRH agonists, which induce an initial testosterone surge, Teverelix provides immediate receptor antagonism, enabling rapid suppression of luteinizing hormone (LH), follicle...