Telix Pharmaceuticals has resubmitted its NDA to the U.S. FDA for Pixclara (TLX101-Px), an investigational 18F-FET PET imaging agent designed to help detect recurrent or progressive glioma in adult and pediatric patients.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
Telix Pharmaceuticals has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for TLX101-Px (Pixclara®, 18F-FET), an investigational PET imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related changes in both adult and pediatric patients.
The resubmission follows the company’s response to a previous Complete Response Letter issued by the FDA. Telix stated that the updated application includes additional data and statistical analyses requested by regulators, together with the original clinical dataset.
According to the company, discussions during a Type A meeting with the agency helped guide the additional information submitted in the revised NDA.
TLX101-Px is a fluorine-18 labeled amino acid PET imaging tracer that targets LAT1 and LAT2 membrane transport proteins, which are commonly overexpressed in glioma cells. By highlighting tumor-associated metabolic activity, the imaging agent aims to help clinicians differentiate true tumor progression from treatment-related effects such as radiation injury or pseudo progression.
Because of the potential to address a significant unmet need in brain cancer imaging, the candidate has received both Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration.
Although amino acid PET tracers such as 18F-FET are already incorporated into international clinical guidelines for glioma imaging, there is currently no FDA-approved targeted amino acid PET imaging agent available commercially in the United States for this purpose.
“Improving the accuracy of glioma diagnosis and management, especially after treatment, remains a critical need,” said David N. Cade, MD, Chief Medical Officer at Telix Pharmaceuticals. He noted that the resubmitted application is supported by a comprehensive dataset generated through collaborations with multiple clinical research centres.
TLX101-Px may also serve as a companion diagnostic for TLX101-Tx (iodofalan I-131), Telix’s investigational LAT1-targeting therapeutic candidate currently being evaluated in the pivotal IPAX-BrIGHT study for glioblastoma.
Maggie Haynes, Executive Director of the Head for the Cure Foundation, said the patient community welcomes the U.S. Food and Drug Administration’s continued guidance and support for the Expanded Access Program for TLX101-Px and hopes the resubmission will lead to a faster review so the imaging option can become available to patients in need.
Gliomas represent the most common tumors arising from the central nervous system, accounting for roughly 30% of all brain and CNS tumors and about 80% of malignant brain tumors. In the United States, approximately six new cases occur per 100,000 people each year. Glioblastoma, the most aggressive form of glioma, is diagnosed in about 22,000 Americans annually. Despite surgery followed by radiation and chemotherapy, recurrence occurs in nearly all patients, and median survival typically ranges between 12 and 15 months after diagnosis.
If approved, Pixclara could become the first targeted amino acid PET imaging agent available in the U.S. to help clinicians better evaluate suspected glioma recurrence and guide treatment decisions.
Reference
Telix Pharmaceuticals Limited. Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate. March 16, 2026, https://telixpharma.com/news-views/telix-resubmits-nda-to-u-s-fda-for-tlx101-px-pixclara-brain-cancer-imaging-candidate/
About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.