Telix Completes Patient Enrollment in TLX591-Px (Illuccix®) Japan Phase 3 Study

• 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.

MELBOURNE, Australia and TOKYO, July 17, 2026 /PRNewswire/ -- Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, "Telix") today announced completion of patient enrollment in the pivotal Phase 3 registration study of TLX591-Px (Illuccix^®, Kit for the preparation of ⁶⁸Ga-PSMA-11^[1]) for prostate cancer imaging in Japanese patients.

Illuccix Japan^[2] is a Phase 3 prospective, open-label, multicenter study designed to evaluate the detection efficacy and safety profile of ⁶⁸Ga-PSMA-11 PET/CT^[3] in Japanese patients with biochemically recurrent (BCR) prostate cancer following prior radical prostatectomy. The primary objective of the study is to compare the sensitivity of ⁶⁸Ga-PSMA-11 PET/CT with conventional imaging modalities, including 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 imaging findings on clinical management decisions.

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."

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^[6].

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. 

Telix's commercial franchise is anchored by its prostate cancer imaging portfolio: Illuccix^® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S. and Gozellix^® (kit for the preparation of gallium-68 gozetotide injection), Telix's next-generation PSMA-PET imaging agent approved by the U.S. FDA. The Company's late-stage therapeutic pipeline includes three assets in pivotal-stage trials - TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (¹³¹I-iodofalan) in recurrent glioblastoma, TLX250-Tx (¹⁷⁷Lu-girentuximab) in kidney cancer, complemented by a deep pipeline of next generation assets.

Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.

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