• Completed enrollment of 105 patients in Phase 3 registration study of TLX591-Px (Illuccix^®) for prostate cancer imaging in Japan.
• The study data will be used to support a New Drug Application (NDA) for TLX591-Px in Japan.

Telix Pharmaceuticals announced completion of patient enrollment in the pivotal Phase 3 registration study of TLX591-Px (Illuccix^®, Kit for the preparation of ⁶⁸Ga-PSMA-11) for prostate cancer imaging in Japanese patients.

Telix is preparing an NDA for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix's application for Conditional Approval is under review by the Japan's Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared.                           

Completion of enrollment represents a significant milestone for the study and advances Telix's registration strategy for Illuccix^® in Japan, one of the world's largest nuclear medicine markets. The study complements Telix's early access and broader prostate cancer portfolio activities in Japan, including named patient use for TLX591-Px^[4] and patient enrollment in the Phase 3 ProstACT Global study of TLX591-Tx (lutetium (¹⁷⁷Lu) rosopatamab tetraxetan)^[5] in advanced prostate cancer.

David N. Cade, MD, Group Chief Medical Officer, Telix, said, "Completion of patient enrollment into this pivotal Phase 3 study was rapid and represents a significant step towards the registration of Illuccix in Japan. We are grateful to the patients, investigators and dedicated study teams across the 11 sites for their commitment to this important study. Together, our goal is to expand access for Japanese men to the benefits of PSMA-PET imaging and thus improve outcomes for men in Japan living with prostate cancer."