New PSMA PET Prep Product Now Available in the U.S.
Offering an extended shelf life, the FDA-approved Gozellix, a preparation kit for gallium-68 (68Ga) gozetotide injection, is indicated for use in PSMA PET imaging of prostate cancer patients with suspected recurrence or metastasis.
Telix Pharmaceuticals has launched the prostate-specific membrane antigen (PSMA) positron emission tomography (PET) preparation kit Gozellix in the United States.
Approved by the Food and Drug Administration (FDA) in March 2025, Gozellix enables preparation of gallium-68 (Ga68) gozetotide injections for patients with suspected prostate cancer (PCa) metastasis who are candidates for definitive treatment, according to Telix Pharmaceutivcals. The company noted Gozellix is also indicated for use in men with suspected biochemical recurrence of PCa.
Approved by the FDA in March 2025, the PSMA PET preparation kit Gozellix is now available in the United States for gallium-68 (68Ga) gozetotide injections in patients with suspected biochemical recurrence of PCa or patients with suspected metastasis who may be candidates for definitive treatment. (Image courtesy of Adobe Stock.)
In addition to 90 percent specificity for PCa metastasis, Telix Pharmaceuticals said research has demonstrated that Gozellix enables detection of millimeter-scale micrometastases in patients with prostate-specific antigen (PSA) levels as low as 0.02 ng/mL5.
Emphasizing the product’s shelf life of up to six hours, the company suggested that Gozellix may bolster scheduling flexibility and broaden access for patients with PCa who may not live in close proximity to facilities with available PSMA PET imaging.
“(Gozellix) delivers a new level of flexibility in distribution, production and scheduling along with the high standard of service and reliability that customers have come to expect from Telix,” noted Kevin Richardson, the chief executive officer of precision medicine at Telix Pharmaceuticals.
Telix Pharmaceuticals noted that Gozellix is now available through Cardinal Health, Jubilant Radiopharma, PharmaLogic Holding Corp., and RLS Radiopharmacies.
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