MELBOURNE, Australia, and TOKYO, Japan, July 17, 2026
Telix Pharmaceuticals has completed patient enrollment in its pivotal Phase 3 registration study evaluating TLX591-Px (Illuccix®) for prostate cancer imaging in Japan, marking a major milestone in the company’s regulatory strategy for one of the world’s largest nuclear medicine markets. The multicenter study successfully enrolled 105 Japanese patients with biochemically recurrent (BCR) prostate cancer following radical prostatectomy and is designed to evaluate the diagnostic efficacy and safety of 68Ga-PSMA-11 PET/CT imaging. The clinical data generated from the study will support a New Drug Application (NDA) submission in Japan while complementing Telix’s ongoing application for Conditional Approval currently under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Successful completion of enrollment reinforces Telix’s commitment to expanding access to PSMA-PET imaging and strengthening its prostate cancer diagnostic portfolio across the Asia-Pacific region.
Phase 3 Study Evaluates Advanced PSMA-PET Imaging in Recurrent Prostate Cancer
The Illuccix Japan Phase 3 study is a prospective, open-label, multicenter clinical trial designed to assess the ability of 68Ga-PSMA-11 PET/CT to detect recurrent prostate cancer in Japanese patients whose disease has returned following previous surgical treatment. The study’s primary endpoint compares the sensitivity of PSMA-PET imaging against conventional imaging techniques, including computed tomography (CT) and bone scintigraphy, for identifying metastatic disease. Secondary objectives include evaluating the diagnostic accuracy of detecting both local and distant lesions, assessing the safety and tolerability of the imaging agent, and determining how imaging results influence clinical treatment decisions. By generating local clinical evidence in Japanese patients, the trial is expected to provide important data supporting regulatory review while demonstrating the value of advanced molecular imaging for earlier and more accurate detection of recurrent prostate cancer.
Registration Strategy Advances Alongside Broader Prostate Cancer Portfolio
With enrollment now complete, Telix is preparing its New Drug Application for submission in Japan using the Phase 3 study data while simultaneously working with the PMDA on its ongoing Conditional Approval application. If Conditional Approval is granted, the company expects to benefit from an expedited NDA review process while final clinical datasets are completed. The Illuccix registration strategy also aligns with Telix’s broader prostate cancer development activities in Japan, including named-patient access programs for TLX591-Px and participation in the global Phase 3 ProstACT study evaluating TLX591-Tx (lutetium-177 rosopatamab tetraxetan) for patients with advanced prostate cancer. Together, these initiatives strengthen the company’s expanding portfolio of diagnostic and therapeutic radiopharmaceuticals designed to improve disease detection, treatment planning, and patient outcomes across multiple stages of prostate cancer.
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Enrollment Milestone Strengthens Telix’s Nuclear Medicine Leadership
The rapid completion of patient enrollment across 11 clinical sites highlights strong investigator participation and growing interest in PSMA-targeted molecular imaging within Japan. According to David N. Cade, M.D., Group Chief Medical Officer of Telix, the achievement brings the company significantly closer to making Illuccix® available to Japanese patients while expanding access to advanced diagnostic technologies capable of improving clinical decision-making. As demand for precision imaging continues to increase globally, successful registration of Illuccix in Japan would further strengthen Telix’s leadership in the field of nuclear medicine and precision oncology. The completion of this pivotal Phase 3 study represents another important milestone in the company’s strategy to deliver innovative radiopharmaceutical imaging agents that enable earlier diagnosis, more accurate staging, and improved management of prostate cancer worldwide.
Source:Telix Pharmaceuticals, press release
