Structure of Fluciclovine (unlabelled parent compound, from PubChem) — Unlabelled parent compoundPubChem CID 10820564

[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: 1

Prostate cancer

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

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)

Clinical literature

Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.

Prospective evaluation of fluciclovine (18F) PET-CT and MRI in detection of recurrent prostate cancer in non-prostatectomy patients.
2018 · Eur J Radiol · Prospective
The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval.
2021 · Mol Imaging Biol · Retrospective

Precursor

Common precursor: —
Suppliers seen in the literature: —
Cited suppliers in indexed syntheses: Blue Earth Diagnostics Limited
Typical final purification: —

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Quality control Preliminary - inferred from compound class

Ph. Eur. monograph: not verified No Ph. Eur. check is recorded for this entry.
USP monograph: not verified No USP check is recorded for this entry.

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.