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
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| FASTlab | vendor cassette | — | 49.1 ± 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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Get in touchQuality control Preliminary — inferred from compound class
- Ph. Eur. monograph
- —
- USP monograph
- —
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
Setting up quality control?We can help you scope the equipment needed to release [18F]FACBC.
Get in touchNotes
Added from reverse module search (stage 6); 10 article(s) with F-18.