Medicus Pharma Submits Optimized Protocol for Teverelix to FDA

Medicus Pharma submitted an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration (FDA) for Teverelix®. Teverelix is an investigational, long-acting GnRH antagonist being developed for patients with advanced prostate cancer who have an increased cardiovascular risk. The company's CEO, Dr Raza Bokhari, stated the protocol aims to establish a defined and potentially more capital-efficient pathway toward registration and explore a strategic partnership. The study is stage-gated, beginning with approximately 80 randomized patients, with the potential to enroll an additional 528 participants if criteria are met.

The submission outlines a potential market pathway for Teverelix, which is currently under development for advanced prostate cancer. The protocol is designed to replace criteria from a previously FDA-cleared 40-patient study. The successful acceptance of this design by the FDA would allow the program to expand into a larger registration-intent study.