PHILADELPHIA — September 29, 2026

Medicus Pharma Ltd. announced that it has submitted an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration (FDA) for Teverelix, its investigational next-generation long-acting GnRH antagonist, in patients with advanced prostate cancer (APC) who are at increased cardiovascular risk. The proposed design is intended to combine dose optimization and registration-intent development into a single stage-gated program. The study would begin with approximately 80 randomized patients, replacing a previously FDA-cleared 40-patient open-label Phase 2b dose-optimization study, before potentially expanding by approximately 528 additional patients to approximately 608 participants if predefined continuation criteria are met. Medicus said the approach could reduce the previously contemplated development population of approximately 1,500 patients to about 600, subject to FDA agreement and successful execution.

Proposed Program Targets Cardiovascular Differentiation

The proposed seamless study is designed to evaluate testosterone suppression while prospectively assessing cardiovascular differentiation in APC patients with elevated cardiovascular risk. Medicus plans to incorporate a 12-month coronary non-calcified plaque endpoint measured using non-invasive coronary CT angiography (CCTA), with standardized imaging at baseline and Month 12 and blinded central quantitative analysis. The company said the approach is informed by randomized clinical evidence published in JAMA Cardiology in 2026 showing that differences in coronary plaque progression between GnRH treatment pathways can be measured using CCTA over 12 months. The proposed protocol would combine testosterone-suppression requirements with coronary plaque assessment while allowing longer-term cardiovascular event follow-up in the same patients. However, the ability of this endpoint and overall design to support registration remains subject to FDA review.

Teverelix Moves From Dose Optimization Toward Registration-Intent Development

The FDA previously granted Study May Proceed clearance for a 40-patient open-label Phase 2b dose-optimization study of Teverelix in February 2026. That study was designed to confirm dosing and sustained testosterone suppression in men with advanced prostate cancer appropriate for androgen deprivation therapy. Medicus has instead proposed an approximately 80-patient randomized initial stage within the larger seamless program, with eligible participants potentially contributing to final registration analyses. The company said it continues to prepare for clinical development activities, including GMP-grade manufacturing, quality release and other study-readiness work expected to be completed before the end of 2026. Teverelix is an investigational long-acting GnRH antagonist formulated as a microcrystalline suspension and is designed to provide immediate receptor antagonism without the initial testosterone surge associated with GnRH agonists.

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Medicus Seeks Strategic Partner for APC Program

Medicus intends to use FDA feedback on the proposed protocol to support strategic partnering discussions rather than independently fund execution of the full APC registrational program at this time. If FDA agrees with the proposed development approach, the company plans to seek a pharmaceutical partner to fund and execute subsequent clinical development and commercialization. Medicus emphasized that there is no assurance that FDA will agree with the protocol, that the proposed development pathway will ultimately support registration, or that a licensing or strategic transaction will be completed. Teverelix is also being developed across other hormone-dependent indications, including acute urinary retention relapse associated with enlarged prostate and symptomatic endometriosis. The company’s broader strategy is focused on advancing selected therapeutic programs through clinical and regulatory milestones while using strategic partnerships to support later-stage development and commercialization.

Source :Medicus Pharma press release