News & Views | Telix Pharmaceuticals Limited

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

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.

First U.S. Patient Dosed in BiPASS: Phase 3 Prostate Cancer Diagnosis Study

Telix today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET imaging agents, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies.

Telix at SUO 2025

Join Telix at the 2025 Society of Urologic Oncology (SUO) Annual Meeting, one of the world’s leading international congresses dedicated to advances in urologic cancer care. Telix will be showcasing its Phase 3 precision imaging and therapeutic trials in prostate and kidney cancer.

ZIRCON-X Analysis: TLX250-CDx Impacts Clinical Decision Making for Almost Half of Patients with Indeterminate Renal Masses

Telix today announces results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®[1], 89Zr-DFO-girentuximab) PET/CT[2] would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Phoenix, AZ, December 2 – 5, 2025.

OPALESCENCE Trial Published in EJNMMI: Confirms Theranostic Potential of TLX250-CDx in Breast Cancer

Telix today announces that final positive results from the Phase 2 OPALESCENCE trial[1] of TLX250-CDx (89Zr-girentuximab) in metastatic triple negative breast cancer (mTNBC) have been published in the European Journal of Nuclear Medicine and Molecular Imaging.

TLX250-CDx (Zircaix®) Included in Leading International Guidelines for Renal Imaging

Telix today welcomes updated guidelines from the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the European Association of Nuclear Medicine (EANM) and The American College of Nuclear Medicine (ACNM) that, for the first time, include the use of Telix’s investigational PET agent, TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), for molecular imaging of renal masses.

Telix Doses First Patient in SOLACE Trial for Metastatic Bone Pain

Telix today announces that it has dosed the first patient in a Phase 1 clinical trial of TLX090 (153Samarium (Sm)-DOTMP), a therapeutic radiopharmaceutical candidate for treating pain associated with bone metastasis.

TLX400 Therapy Published in Journal of Nuclear Medicine

Telix today announces that its Fibroblast Activation Protein (FAP)-targeting therapy candidate, TLX400, has been published in the Journal of Nuclear Medicine. TLX400 demonstrated clinical antitumor activity with a manageable safety profile in subjects with advanced sarcoma, a patient population with limited treatment options

Telix Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis

Telix today announces it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix® and Gozellix® (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis.

Illuccix China Phase 3 Study Completes Enrolment

Telix today announces that that the pivotal Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients has completed patient enrolment.