Tracers / [18F]THK5351

[18F]THK5351

Also written as [18F]THK-5351; [18F]THK5351; [F-18]THK-5351; [F-18]THK5351; F-18 THK-5351; F-18 THK5351; F-18-THK5351
Radionuclide
F-18 t½ 109.7 min
Modality
PET
Production route
Cyclotron liquid target
Stage
Research
Syntheses indexed
4

What it is

Compound class
Arylquinoline
Target / mechanism
Aggregated tau (neurofibrillary tangles); substantial off-target binding to monoamine oxidase-B (MAO-B) PMID 28359327 / DOI 10.1186/s13195-017-0253-y; PMID 29752516 / DOI 10.1007/s00259-018-4012-5
Clinical application
Investigated for tau imaging in Alzheimer disease and other tauopathies (interpretation confounded by MAO-B binding) PMID 28359327 / DOI 10.1186/s13195-017-0253-y
Theranostic pair

Regulatory status

FDA
No Drugs@FDA / openFDA drug registry — no approved application found; search: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=THK5351
EMA (centralised)
Other approvals
Brand names

Clinical use

Typical injected activity
~370-378 MBq (healthy volunteers 377.8 +/- 14.0 MBq, range 340-397) PMID 28336780 / DOI 10.2967/jnumed.116.189126
Uptake time
Brain PET acquired 50-60 min after injection PMID 31191427 / DOI 10.3389/fneur.2019.00503

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
ELIXYS FLEX/CHEM
Sofie Biosciences
vendor cassetteHPLC+SPE23%, 48%, and 55%
yes
99.98% ± 0.04%THK-5352
Tohoku University
29031087
2017 Appl Radiat Isot
an automated radiosynthesis routine (ELIXYS, Sofie Biosciences) — [18F]THK-5351 decay-corrected radiochemical yields post-HPLC purification were 23%, 48%, and 55%, using precursor masses of 0.1, 0.2, and 0.5 mg, respectively.
27355840
2016 PLoS One
In-house / custom builtcustom manifold>95%34912209
2021 Front Aging Neurosci
manufactured at the Cyclotron and Radioisotope Center of Tohoku University using a semiautomated system developed in-house
HPLC21 ± 3.5%
no
O-THP protected tosyl precursor27859483
2017 J Labelled Comp Radiopharm
the use of a commercially available radiosynthesis module, the GE TRACERlab™ FXFN — an uncorrected radiochemical yield of 21 ± 3.5%

Precursor

Common precursor
OTHP-protected tosylate precursor THK-5352 ((S)-2-(2-methylaminopyrid-5-yl)-6-[[2-(tetrahydro-2H-pyran-2-yloxy)-3-tosyloxy]propoxy]quinoline); nucleophilic [18F]fluorination then acid hydrolysis PMID 29031087 / DOI 10.1016/j.apradiso.2017.10.002
Suppliers seen in the literature
Synthesised and supplied by Tohoku University (Japan)
Cited suppliers in indexed syntheses
Tohoku University
Typical final purification
SPE

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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

Off-target MAO-B binding is a known limitation.