Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce that the company has received “study may proceed” clearance from the U.S. Food and Drug Administration 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).

Bokhari told Proactive that the Teverelix trial will be conducted as a Phase 2b open-label study enrolling approximately 40 men with advanced prostate cancer who are appropriate candidates for androgen deprivation therapy (ADT). Patients will undergo treatment for approximately 22 weeks. The study’s primary endpoint is confirmation of medical castration by Day 29, with sustained testosterone suppression maintained through Day 155. The company is targeting a probability of success exceeding 90% for achieving this endpoint.

Teverelix trifluoroacetate is formulated as a long-acting injectable GnRH antagonist delivered as a microcrystalline suspension. Unlike GnRH agonists—which typically cause an initial surge in testosterone levels before suppression—Teverelix works through immediate receptor antagonism. This mechanism enables rapid suppression of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and downstream sex hormones without the testosterone “flare” associated with agonist therapies.

This rapid suppression profile may hold particular clinical relevance for patients with advanced prostate cancer who are at elevated cardiovascular risk. Emerging evidence suggests that persistent FSH exposure in patients treated with GnRH agonists may contribute to adverse cardiovascular outcomes. While further clinical validation is required, prior Teverelix studies have not demonstrated significant cardiovascular safety signals to date.

Cardiovascular disease remains one of the leading causes of non-cancer mortality in men with prostate cancer, accounting for approximately 30% of deaths. The risk can be further amplified during androgen deprivation therapy, particularly among patients with pre-existing cardiovascular disease. Clinical and observational data indicate that such patients may face a five- to six-fold higher incidence of major adverse cardiovascular events (MACE) when treated with GnRH agonists compared to GnRH antagonists.

With FDA clearance now secured, Medicus Pharma is preparing to advance the Phase 2b study as it continues to evaluate Teverelix’s potential as a differentiated therapeutic option in the treatment of advanced prostate cancer.

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