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TLX007-CDx (brand name Gozellix) is an FDA-approved diagnostic radiopharmaceutical kit used to prepare gallium-68 (68Ga) gozetotide injection, a next-generation prostate-specific membrane antigen (PSMA)-targeted PET imaging agent. After radiolabeling with 68Ga, it is indicated for PET scanning of PSMA-positive lesions in adult men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. The product offers a longer shelf life and extended distribution radius compared to previous 68Ga-based agents, enabling broader access to advanced PSMA-PET imaging. It builds on the success of Telix’s earlier product Illuccix but features improved logistics and scalability. The mechanism involves targeting PSMA-expressing cells using the radiolabeled ligand gozetotide, allowing sensitive detection of prostate cancer lesions via PET scan[2][4][5][6][8].
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