The U.S. Food and Drug Administration has accepted the resubmitted New Drug Application for TLX101-Px, also known as Pixclara, a new PET imaging agent designed to better detect and evaluate brain tumors in both adults and children.
One of the biggest challenges in treating gliomas is telling the difference between true tumor growth and changes caused by treatment, such as inflammation or scar tissue. Pixclara works as an amino acid PET tracer, helping doctors more clearly see tumor boundaries, choose accurate biopsy sites, and better plan radiation therapy.
The imaging agent targets specific transport proteins (LAT1 and LAT2) found on tumor cells. It is also being used to help identify patients for the phase 3 IPAX-BrIGHT trial, which is testing a related therapy for recurrent glioblastoma.
Pixclara has already received Orphan Drug and Fast Track designations, and a final decision from the FDA is expected by September 11, 2026. If approved, it could significantly improve how doctors monitor and treat brain tumors by providing a clearer picture of remaining cancer after treatment.