Pixclara FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 28, 2024.
FDA Approved: No
Brand name: Pixclara
Generic name: floretyrosine f-18
Company: Telix Pharmaceuticals Limited
Treatment for: Diagnosis and Investigation
Pixclara (floretyrosine f-18), or TLX101-CDx, is a PET imaging agent in development for the characterization of progressive or recurrent glioma.
- Gliomas are the most common and aggressive form of primary brain cancer, accounting for 80% of all malignant brain tumors.
- Pixclara is intended to improve the diagnosis and management of glioma particularly in the post-treatment setting, where it has the potential to determine if the glioma is progressing or undergoing a treatment related change.
- Pixclara targets the membrane transport proteins known as LAT1 and LAT2, which are validated targets that are highly expressed in several solid tumours, including malignancies of the central nervous system.
- Pixclara may be potentially utilized as a companion diagnostic agent to TLX101, Telix’s LAT1-targeting investigational glioblastoma therapy.
- Pixclara has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA).
Development timeline for Pixclara
Further information
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