# Floretyrosine F 18

Source: https://onco.cc/drugs/floretyrosine-f18/  
OnCo record `floretyrosine-f18` (Imaging agent). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Pixclara is a tracer for a PET scan of the brain. After treatment for a glioma, it helps doctors tell whether a change seen on a scan is the tumour growing back or damage caused by the treatment, alongside the other tests.

## Summary

Floretyrosine F 18 (Pixclara; Telix Pharmaceuticals (US) Inc.) was approved by the FDA on 11 September 2026 as a novel drug, for use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and children aged 1 month and older. It is given as a single injection into a vein. The label describes two studies: a prospective single-centre study (NCT04044937) whose image analysis included 127 patients with suspected recurrent or progressive glioma of any grade, 116 of them adults, read blind by three nuclear medicine experts against a composite reference standard set by an expert panel; and a blinded central read of images collected in routine practice at several centres.

## Fields

- Kind: Imaging agent
- Status: approved
- Last checked: 2026-11-03
- Also known as: floretyrosine F 18; floretyrosine F18; floretyrosine; Pixclara
- Tags: universe-gap; fda-novel; diagnostic
- Brand: Pixclara
- Modality: PET radiotracer (radiolabelled amino acid)
- Mechanism: A radiolabelled form of the amino acid tyrosine, carried into cells by the large neutral amino acid transporters (LAT), which are highly expressed at the blood-brain barrier and in glioma tissue, so the tracer builds up in tumour; fluorine-18 emits positrons for PET imaging (US label, section 12.1).
- Approvals: US 2026: PET to differentiate recurrent or progressive glioma from treatment-related change, with other diagnostic evaluations, in adults and children 1 month and older

## Sources

- FDA: Novel drug approvals for 2026: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dc78b128-3768-4448-b019-61574db05714
- US label at approval (FDA, NDA 218592): https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218592Orig1s000lbl.pdf

## Connected records

- drugs: [Fluciclovine F-18](https://onco.cc/drugs/fluciclovine-f18/)
- cancers: [Astrocytoma, IDH-mutant (grades 2 to 4)](https://onco.cc/cancers/idh-mutant-astrocytoma/), [Glioma & glioblastoma](https://onco.cc/cancers/glioblastoma/), [Oligodendroglioma, IDH-mutant and 1p/19q-codeleted](https://onco.cc/cancers/oligodendroglioma/), [Paediatric high-grade glioma (excluding diffuse midline glioma)](https://onco.cc/cancers/paediatric-high-grade-glioma/), [Paediatric low-grade glioma](https://onco.cc/cancers/paediatric-low-grade-glioma/)
- technologies: [PET (positron emission tomography)](https://onco.cc/technologies/pet/)
- companies: [Telix Pharmaceuticals](https://onco.cc/companies/telix/)
- terms: [Radiation necrosis (brain)](https://onco.cc/terms/radiation-necrosis/)

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