Drug intelligence / Profile preview

[18F]fluoroedaravone

Development stage
Phase 1
Lead developer
St. Jude Children's Research Hospital
Modality
Small Molecules, Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

[18F]fluoroedaravone (also known as [18F]FEDV) is a novel small molecule positron emission tomography (PET) imaging radiotracer developed by St. Jude Children's Research Hospital in collaboration with the University of Virginia. It is a fluorine-18-radiolabeled analogue of edaravone, an FDA-approved antioxidant marketed as Radicava for the treatment of amyotrophic lateral sclerosis (ALS) and stroke. Designed to cross the blood-brain barrier, [18F]fluoroedaravone selectively accumulates in regions of high oxidative stress by reacting with reactive oxygen and nitrogen species (RONS), which are key markers of neurodegeneration and tissue injury. Preclinical studies have demonstrated its ability to detect RONS in stroke and tauopathy (Alzheimer's disease) models. The tracer is being evaluated in a first-in-human Phase 1 clinical trial (the IRONHORSE study) to assess its safety, biodistribution, and radiation dosimetry in healthy adult volunteers, with potential future applications spanning neurodegenerative diseases, cancer, chronic inflammation, and diabetes.

Other names
[18F]FEDV[18F]-fluoroedaravone18F-fluoroedaravonefluoroedaravone [18F]
02

Targets

RNS (Peroxynitrite and related reactive nitrogen species)

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