Telix Receives FDA Acceptance for TLX101-Px (Pixclara®) in Glioma Imaging
Friday, April 10, 2026
Telix has announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara®), an investigational PET imaging agent designed for the detection of glioma, a type of brain cancer.
TLX101-Px may also support patient selection and treatment monitoring for Telix’s therapeutic candidate, TLX101-Tx, which is currently being studied in a late-stage clinical trial for patients with recurrent glioblastoma.
Gliomas are the most common type of cancer originating in the central nervous system, accounting for around 30% of all brain and CNS tumours and about 80% of malignant brain tumours. In the United States, approximately 24,000 new cases are diagnosed each year. Glioblastoma, the most aggressive form, has a poor prognosis despite standard treatment, which typically includes surgery followed by radiotherapy and chemotherapy. Recurrence is almost inevitable, with average survival ranging from 12 to 15 months after diagnosis.
The agency has set a target decision date of 11 September 2026 under the Prescription Drug User Fee Act (PDUFA).
TLX101-Px is intended to help distinguish tumour progression from treatment-related changes in both adult and paediatric patients with recurrent or progressive glioma. This remains a major challenge in clinical practice, where accurate imaging after treatment is often limited. The product has already received Orphan Drug and Fast Track designations from the FDA, reflecting its potential to address an unmet medical need.
The imaging agent uses 18F-FET, a tracer that targets L-type amino acid transporters (LAT1 and LAT2), which are commonly overexpressed in glioma cells. This mechanism may allow more precise identification of active tumour tissue. The technology is already recommended in international clinical guidelines and is used in several regions outside the United States.
Telix stated that no revenue from Pixclara® has been included in its financial guidance for 2026. Both TLX101-Px and TLX101-Tx are still under investigation and have not yet received marketing approval in any region.
Source: telixpharma.com
