Tracers / [18F]FACBC

[18F]FACBC

Also written as [18F]FACBC; [F-18]FACBC; anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid; F-18 FACBC; F-18 Fluciclovine; F-18-FACBC; F-18-Fluciclovine
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
Stage
Approved
Syntheses indexed
3

What it is

Compound class
Radiolabelled synthetic (non-natural) leucine analogue (fluciclovine)
Target / mechanism
Amino acid transporters ASCT2 and LAT1, upregulated on prostate-cancer cells EMA EPAR (Axumin product information)
Clinical application
PET imaging to detect recurrence of prostate cancer in men with suspected recurrence based on elevated PSA after primary curative treatment FDA label NDA208054
Theranostic pair

Regulatory status

FDA
2016, Axumin, Blue Earth Diagnostics FDA (Drugs@FDA/openFDA): NDA208054, approved 2016-05-27
EMA (centralised)
2017, Axumin, Blue Earth Diagnostics EMA medicines register export (2026-09-09): EMEA/H/C/004197, 'Authorised', authorised 22 May 2017
Other approvals
Brand names
Axumin

Clinical use

Typical injected activity
Uptake time

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
FASTlabvendor cassette49.1 ± 3.8%99.18 ± 0.13%
Blue Earth Diagnostics Limited
33237350
2020 EJNMMI Res
18F-Fluciclovine was produced on a FASTlab synthesiser — produced with a radioactivity yield of 49.1 ± 3.8% (n = 4)
27694174
2016 J Nucl Med
24%
yes
12798374
2003 Appl Radiat Isot
An automated radiosynthesis has been developed which provides anti-[18F]FACBC in 24% decay-corrected yield. — provides anti-[18F]FACBC in 24% decay-corrected yield

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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); 10 article(s) with F-18.