Medicus Pharma Submits Optimized Teverelix® Registrational Protocol to FDA to Create Partner Ready Program in Advanced Prostate Cancer
Key Highlights
- ➤Medicus Pharma (MDCX) submits optimized Phase 2b/3 Teverelix protocol to FDA
- ➤Proposed program starts with approximately 80 randomized patients
- ➤Study could total approximately 608 patients after adding approximately 528 patients
- ➤Plan could reduce enrollment from approximately 1,500 patients to approximately 600
- ➤Medicus intends to seek a strategic partner rather than independently fund execution
Expert Statements
Raza Bokhari, Executive Chairman and CEO of Medicus Pharma
“Our objective with this submission is not to commit Medicus capital to another APC clinical study—it is to define the most efficient registrational pathway possible and make Teverelix ready for a strategic partner.”
Raza Bokhari, Executive Chairman and CEO of Medicus Pharma
“The FDA previously cleared a 40-patient open-label dose-optimization study. Rather than independently funding that study, we have now proposed an approximately 600-patient seamless registration-intent program that incorporates a more rigorous 80-patient randomized dose-optimization stage and could reduce the overall development population from ~ 1,500 patients to ~ 600 and is more likely to be partner-ready.”
PHILADELPHIA, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today 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 advanced prostate cancer (“APC”) patients at increased cardiovascular (“CV”) risk.
The submission is designed to establish a defined, capital-efficient and partner-ready registrational pathway for Teverelix without Medicus independently funding an additional clinical development study in the APC program at this time. Importantly, the proposed design is stage-gated: it begins with approximately 80 randomized patients, incorporating and replacing the previously FDA-cleared stand-alone 40-patient open-label Phase 2b dose-optimization study. Once predefined continuation criteria have been satisfied, the program would then proceed to add approximately 528 patients, for approximately 608 patients in total, with eligible patients from the initial stage contributing to the final registration analyses.
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