Pixclara (floretyrosine F 18 or 18F-FET)

September 14, 2026: Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) said the FDA approved Pixclara (floretyrosine F 18; 18F-FET), an amino acid PET imaging drug for glioma. The label is for use with PET, alongside other diagnostic evaluations, to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients 1 month and older.

The company said Pixclara is the first FDA-approved FET-PET imaging drug for glioma in the U.S. and the only FDA-approved radiopharmaceutical imaging drug for glioma. The release notes FET-PET is recommended in international clinical practice guidelines, including NCCN Guidelines.

Safety data cited in the release covered 382 glioma patients (371 adults, 11 pediatric patients). Adverse reactions occurring in at least 0.5% of patients were headache (0.5%); less frequent events included nausea, injection site reaction, fatigue, and malaise.

The release also mentions Pixclara/TLX101-Px is in a Phase 3 registrational study for a potential label expansion in diagnosis of brain metastases, with the company noting an IND was cleared by FDA on August 20, 2026.