First Patient Dosed in Pivotal Phase 3 Study of TLX591-Px (Illuccix®) for Prostate Cancer Imaging in Japanese Patients

Melbourne (Australia) | 29 January 2026

Telix today announces that the first patient has been dosed in the Phase 3 registration study of TLX591-Px (Illuccix®, Kit for the preparation of ⁶⁸Ga-PSMA-11) for prostate cancer imaging in Japanese patients. The patient was dosed at Shonan Kamakura General Hospital (SKGH) in Kamakura, Japan.

Illuccix Japan[1] is a Phase 3 prospective, open-label, multicenter study designed to evaluate the detection efficacy and safety profile of ⁶⁸Ga-PSMA-11 PET/CT[2] in Japanese patients with biochemically recurrent (BCR) prostate cancer following prior radical prostatectomy. The study will enroll up to 105 Japanese men at 11 sites and data are intended to support a future marketing authorization application for TLX591-Px in Japan.

The primary objective of the study is to compare the sensitivity of ⁶⁸Ga-PSMA-11 PET/CT to conventional imaging (CT and bone scintigraphy) for the detection of metastatic lesions. Secondary objectives include evaluating diagnostic performance for local and distant lesions, safety and tolerability, and the impact of ⁶⁸Ga-PSMA-11 PET/CT on clinical management decisions.

Commencement of the trial augments Telix’s early access and clinical activities in the world’s second-largest market for nuclear medicine. This includes compassionate use for TLX591-Px in Japan[3], and the Phase 3 ProstACT Global study of TLX591-Tx (lutetium (¹⁷⁷Lu) rosopatamab tetraxetan)[4] in advanced prostate cancer, which is now open for enrollment in Japan[5].

Dr. David N. Cade, Telix Group Chief Medical Officer, commented, “PSMA-PET[6] imaging has fundamentally changed how we detect and manage prostate cancer, providing greater accuracy and confidence in treatment planning compared with conventional imaging. Yet, access remains limited in much of Japan, where ⁶⁸Ga-PSMA-11 is not fully validated in the local clinical setting or across all stages of the disease. This milestone, together with Telix’s existing compassionate use supply to address unmet patient need, brings us significantly closer to improving access to gallium-based PSMA-PET and improving outcomes for men living with prostate cancer in Japan.”

About Prostate Cancer in Japan

The Asia Pacific region comprises approximately one-third of the world’s male population and includes many nations whose populations are ageing or increasingly adopting a more affluent, ‘Western-style’ lifestyle, the two main demographic trends driving increasing cancer incidence rates. Consequently, the incidence of prostate cancer is increasing in many parts of the region.

Prostate cancer is the most common cancer in Japanese men with more than 104,000 new diagnoses each year, and the sixth leading cause of cancer-related death with over 14,000 deaths annually[7].

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TLX591-Px (Illuccix®), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally, excluding in Japan where use is investigational only.

[1] Japan Registry of Clinical Trials identifier: JRCT2031250473.

[2] Positron emission tomography/computed tomography.

[3] Since January 2024, Telix has supported compassionate use of TLX591-Px in Japan through site-requested supply, consistent with local regulation.

[4] ClinicalTrials.gov ID: NCT06520345.

[5] Japanese regulator Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval for a Japan-specific Part 1 in nine patients, prior to commencing Part 2.

[6] Imaging of prostate-specific membrane antigen with positron emission tomography.

[7] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.