# Telix Completes Patient Enrollment in TLX591-Px (Illuccix®) Japan Phase 3 Study - Link: https://www.thailand-business-news.com/pr-news/telix-completes-patient-enrollment-in-tlx591-px-illuccix-japan-phase-3-study - Published: 2026-07-17T05:00:00+07:00 - Author: PR Newswire | | ◦ 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 ^(68)Ga-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 ^(68)Ga-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 ^(68)Ga-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 (^(177)Lu) 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 (^(177)Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (^(131)I-iodofalan) in recurrent glioblastoma, TLX250-Tx (^(177)Lu-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](http://www.telixpharma.com/) or follow Telix on [LinkedIn](https://www.linkedin.com/company/telixpharma/), [X](https://x.com/TelixPharma) and [Facebook](https://www.facebook.com/TelixPharma). **Telix Contacts** | **Investor Relations** **Annie Kasparian** [Annie.kasparian@telixpharma.com](https://www.thailand-business-news.com/pr-news/Annie.kasparian@telixpharma.com) **Charlene Jaw** [Charlene.jaw@telixpharma.com](https://www.thailand-business-news.com/pr-news/Charlene.jaw@telixpharma.com) | **Media ** **Eliza Schleifstein** [Eliza@schleifsteinpr.com](https://www.thailand-business-news.com/pr-news/Eliza@schleifsteinpr.com) | Legal Notices _Cautionary Statement Regarding Forward-Looking Statements._   _You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website._ _The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement._ _This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe"," outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements._ _Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ^(®) or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties._ _©2026 Telix Pharmaceuticals Limited. All rights reserved._ | ^([1]) 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. ^([2]) Japan Registry of Clinical Trials identifier: JRCT2031250473.^([3]) Positron emission tomography/computed tomography.^([4]) Since January 2024, Telix has supported the Japanese version of compassionate use of TLX591-Px in Japan through site-requested supply, consistent with local regulation.^([5]) ClinicalTrials.gov ID: [NCT06520345](https://clinicaltrials.gov/study/NCT06520345).^([6]) Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024. |   --- | This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. | --- **Read the original article :** [Telix Completes Patient Enrollment in TLX591-Px (Illuccix®) Japan Phase 3 Study ](http://www.prnasia.com/story/archive/5006169_AE06169_0?rand=184833)