FDA Sets September Target Action Date for Pixclara PET Imaging Agent in Glioma

The Food and Drug Administration (FDA) accepted the resubmitted New Drug Application (NDA) for Pixclara (floretyrosine F 18; TLX101-Px; Telix Pharmaceuticals, Melbourne, Australia; Indianapolis, IN), an investigational PET imaging agent for glioma. The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 11, 2026, according to a statement from Telix.

Pixclara is being developed for characterization of recurrent or progressive glioma from treatment-related changes in adult and pediatric patients. Distinguishing tumor progression from treatment-related imaging changes remains a clinical challenge in glioma care, particularly after surgery, radiotherapy, and chemotherapy.

Regulatory and Clinical Context

• Pixclara has received Fast Track and Orphan Drug designations from the FDA.
• The agent targets L-type amino acid transporters 1 and 2, also known as LAT1 and LAT2.
• PET imaging with 18F-FET is already used in some clinical settings internationally and is included in international clinical practice guidelines, according to Telix.

In a statement from Telix, the company stated that it is also evaluating TLX101-Px as a potential patient selection and response assessment tool for TLX101-Tx (iodofalan I 131), a LAT1-targeting investigational therapy being studied in the pivotal IPAX-BrIGHT trial (NCT07100730) for recurrent glioblastoma.

Source

Telix Pharmaceuticals. FDA accepts NDA for TLX101-Px (Pixclara). Published April 10, 2026. Accessed July 1, 2026. https://telixpharma.com/news-views/fda-accepts-nda-for-tlx101-px-pixclara/