FDA Approves Telix’s Pixclara for Post-Treatment Glioma Imaging

Key Facts

The US Food and Drug Administration approved Telix Pharmaceuticals’ Pixclara, a radioactive diagnostic drug used with positron emission tomography, or PET, to distinguish recurrent or progressive glioma from treatment-related changes in adults and children aged 1 month and older.

The approval is not for an anticancer treatment. Pixclara, whose generic name is floretyrosine F 18 and which is also known as 18F-FET, provides diagnostic images used alongside other medical evaluations to monitor glioma after treatment.

Pixclara consists of a small molecule labeled with the diagnostic isotope fluorine-18. After injection into the bloodstream, it targets the amino-acid transporters LAT1 and LAT2, allowing a PET scanner to detect emissions from the isotope and produce images.

Telix said Pixclara is the first FDA-approved FET-PET imaging drug for glioma. The company added that the technology is recommended in international clinical-practice guidelines, while no FDA-approved product had previously made it available in the US.

Telix resubmitted the New Drug Application on March 13, 2026, and the FDA accepted it on April 10, 2026, setting September 11, 2026, as the target action date. The company announced approval on September 14, 2026.

Telix trades under the ticker TLX on both ASX and NASDAQ. Pixclara joins a precision-diagnostics portfolio that includes Illuccix, commercially available in 22 countries, and Gozellix, which is FDA-approved for prostate imaging; Pixclara is also in a Phase 3 registrational study for a potential expansion into brain-metastasis diagnosis.

When the application was accepted on April 10, 2026, Telix said its 2026 revenue guidance included no contribution from Pixclara. The September 14, 2026 approval disclosure gives no launch date, pricing or revenue estimate, so the near-term financial effect cannot be quantified from these disclosures alone.