Tracers / [18F]flutemetamol

[18F]flutemetamol

Also written as [18F]Flutemetamol; [F-18]Flutemetamol; Flutemetamol
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
Stage
Approved
Syntheses indexed
7

What it is

Compound class
Radiolabelled benzothiazole derivative (amyloid-binding small molecule)
Target / mechanism
β-amyloid aggregates FDA label NDA203137
Clinical application
PET imaging of the brain to estimate β-amyloid neuritic plaque density in adults with cognitive impairment, for evaluation of Alzheimer's disease and other causes of cognitive decline FDA label NDA203137
Theranostic pair

Regulatory status

FDA
2013, Vizamyl, GE Healthcare FDA (Drugs@FDA/openFDA): NDA203137, approved 2013-10-25
EMA (centralised)
2014, Vizamyl, GE Healthcare EMA medicines register export (2026-09-09): EMEA/H/C/002557, 'Authorised'
Other approvals
Brand names
Vizamyl

Clinical use

Typical injected activity
185 MBq (5 mCi) single IV bolus within 40 seconds, up to 10 mL FDA label NDA203137 (human clinical dosing)
Uptake time
Signal increases continually 0–30 min post-injection, then stable from 30 min to at least 120 min FDA label NDA203137

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
29499171
2018 Alzheimers Dement
29114726
2017 JAMA Neurol
36539779
2022 Biomed Eng Online
25366546
2015 Pharm Res
The influence of polysorbate 80 on the radiochemical synthesis of a PET tracer in the FASTlab.
25146124
2014 J Nucl Med
22301718
2012 Neurodegener Dis
42142951
2026 J Nucl Cardiol

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
USP monograph
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrity
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); organic-phase radiosynthesis assumed from isotope/compound class, no synthesis data confirming it -> GC residual solvents (preliminary); conventional nucleophilic 18F-fluorination assumed from isotope/compound class, no synthesis data confirming K222 use -> Kryptofix test (preliminary)

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Added from reverse module search (stage 6); 7 article(s) with F-18.