Core Insights - The company is developing Teverelix® as a leading product for advanced prostate cancer patients with high cardiovascular risk and as a first-in-class treatment for Acute Urinary Retention Relapse prevention, representing a combined market opportunity of approximately US$6 billion [1][20]. Clinical Development - The Phase 2b study is an open-label trial enrolling 40 men with advanced prostate cancer, with a total treatment duration of approximately 22 weeks [2]. - The primary endpoint is to confirm medical castration by Day 29 with sustained suppression through Day 155, targeting a probability exceeding 90% [2][9]. Mechanism of Action - Teverelix is a long-acting injectable GnRH antagonist that provides immediate receptor antagonism, allowing for rapid suppression of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and downstream sex hormones without an initial testosterone surge [4][21]. - This mechanism is particularly relevant for patients with advanced prostate cancer and elevated cardiovascular risk, as GnRH agonists may contribute to adverse cardiovascular outcomes [5][6]. Target Patient Population - Teverelix is specifically developed for advanced prostate cancer patients with objectively defined cardiovascular risk, including those with recent major adverse cardiovascular events (MACE) or severe subclinical atherosclerosis [7]. - Approximately 300,000 to 500,000 men in the U.S. are living with advanced prostate cancer, representing an estimated annual market opportunity exceeding US$4 billion [7]. Regulatory Strategy - The company has received FDA clearance to initiate the Phase 2b study and has aligned on a development indication focused on hormone therapy for advanced prostate cancer patients with increased cardiovascular risk [10][23]. - A clear Phase 3 framework is defined to evaluate sustained castration efficacy alongside cardiovascular outcomes, which may establish Teverelix as a new therapeutic backbone for patients where cardiovascular safety is critical [11][10]. Strategic Partnerships - The company is well-positioned for strategic partnership discussions, particularly with organizations seeking differentiated late-stage oncology assets supported by a clear regulatory and labeling strategy [12]. - The development strategy includes advancing select programs through Phase 2 proof-of-concept and pursuing licensing or strategic partnerships for late-stage development and commercialization [13]. Additional Programs - Medicus is also advancing SkinJect™, a proprietary dissolvable microneedle array platform for the non-invasive treatment of basal cell carcinoma, with topline decision-grade data expected in Q1 2026 [14][27].
Medicus Pharma Receives FDA “Study May Proceed” Clearance For Teverelix® Phase 2b Study in Advanced Prostate Cancer Patients with High Cardiovascular Risk