FDA approves Telix's Pixclara for glioma imaging

Telix Pharmaceuticals announced on September 14, 2026 that the U.S. Food and Drug Administration approved its New Drug Application for Pixclara (floretyrosine F 18, also called 18F-FET), an amino acid positron emission tomography drug for imaging gliomas in the brain¹. The company said Pixclara is the first FDA-approved FET-PET imaging drug for glioma¹.

The drug is a radioactive diagnostic agent meant to be used alongside PET scanning to help distinguish recurrent or progressive glioma from changes caused by prior treatment, used together with other diagnostic tools, and it is approved for both adults and pediatric patients starting at 1 month of age¹.

Telix noted that FET-PET imaging already appears in international clinical guidelines, including those from NCCN, but no FDA-approved version had previously existed in the U.S.¹ The company said gliomas represent roughly 30% of all brain and central nervous system tumors and about 80% of malignant brain tumors¹, with about 24,000 new cases diagnosed annually in the U.S.¹

Mechanistically, Telix said Pixclara pairs a small molecule targeting compound with the radioisotope fluorine-18, which binds to LAT1 and LAT2 amino acid transport proteins on cell membranes, allowing a PET scanner to detect the resulting radioactive signal¹. The company also disclosed that Pixclara, under the designation TLX101-Px, is being studied in a Phase 3 registrational trial for a potential expanded indication in diagnosing brain metastases¹, an IND application for which has been cleared with an FDA Study May Proceed notification¹.

Telix said Pixclara joins Illuccix and Gozellix as part of its precision diagnostics portfolio¹, and that its therapeutic pipeline includes three assets in pivotal trials, TLX591-Tx, TLX101-Tx, and TLX250-Tx, none of which have received marketing authorization in any jurisdiction¹.