The U.S. Food and Drug Administration has accepted Telix Pharmaceuticals’ resubmitted new drug application for TLX101-Px, also known as Pixclara, an investigational PET imaging agent for glioma.
Pixclara is also known as floretyrosine F-18 or F-18 FET. Telix said the agent is designed to characterize recurrent or progressive glioma from treatment-related changes in adult and pediatric patients.
The FDA assigned a Prescription Drug User Fee Act goal date of September 11, 2026. Telix said Pixclara has received orphan drug and fast track designations from the agency.
The company resubmitted the NDA on March 13, 2026. A prior regulatory update from Telix said the resubmission package included additional confirmatory evidence requested by FDA after an earlier complete response letter.
Neuroimaging of glioma with F-18 FET is already recommended in international clinical practice guidelines, according to Telix. The company has said there is no FDA-approved targeted amino acid PET agent available in the U.S. specifically for imaging adult and pediatric glioma patients.
Pixclara has not received marketing authorization in any jurisdiction, according to Telix’s announcement.
Company:Telix Pharmaceuticals
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