Telix wins FDA approval for Pixclara
- Telix (NASDAQ:TLX) received FDA approval for Pixclara on September 14, 2026, making it the first approved FET-PET imaging drug for glioma in the U.S.
- Pixclara is approved for adults and pediatric patients from one month of age to help distinguish recurrent or progressive glioma from treatment-related changes.
- Safety was evaluated in 382 glioma patients, with headache reported in 0.5% and other listed adverse reactions occurring in fewer than 0.5% of patients.
Telix (NASDAQ:TLX) received U.S. Food and Drug Administration approval for Pixclara, or floretyrosine F 18, as a PET imaging drug for evaluating glioma.
Pixclara is indicated alongside other clinical evaluations to help distinguish recurrent or progressive glioma from treatment-related changes in adults and pediatric patients from one month of age.
The approval makes Pixclara the first FDA-approved FET-PET imaging drug for glioma and, according to Telix, the only FDA-approved radiopharmaceutical imaging drug specifically for the disease.
The approval provides access to FET-PET imaging in the U.S., where the imaging approach is supported by clinical guidelines but previously lacked an FDA-approved product.
Pixclara’s safety was evaluated in 382 patients with glioma, with headache reported in 0.5% of patients and nausea, injection-site reaction, fatigue, and malaise each occurring in fewer than 0.5%.
The prescribing information includes warnings covering the risk of image misinterpretation and the cumulative radiation exposure associated with radioactive diagnostic products.
The FDA decision expands Telix’s radiopharmaceutical imaging portfolio into glioma diagnosis, providing a newly approved PET option for assessing suspected disease recurrence or progression after treatment.
