Tracers / [18F]Dolutegravir

[18F]Dolutegravir

Also written as [18F]Dolutegravir; [F-18]Dolutegravir
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
Stage
first-in-human (suitable for human applications)
Syntheses indexed
3

What it is

Compound class
Antiretroviral drug (integrase strand transfer inhibitor, dolutegravir analogue)
Target / mechanism
Clinical application
PET imaging of antiretroviral drug biodistribution and pharmacokinetics at HIV-1 reservoirs/sanctuary sites PMID 35631413
Theranostic pair

Regulatory status

FDA
EMA (centralised)
Other approvals
Brand names

Clinical use

Typical injected activity
Uptake time

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
TRACERlab FX N Pro
GE HealthCare
fixed tubingHPLC+SPE5.1 ± 0.8%
no
>99%2-fluoro-4-nitrobenzonitrile
Herceptin, Roche, Mississauga, ON
35631413
2022 Pharmaceuticals (Basel)
the automation was carried out using a TRACERlab® FX N Pro (GE Healthcare, Chicago, IL, USA) module — afforded ready-to-inject [18F]DTG in 5.1 ± 0.8% (n = 10) decay-corrected radiochemical yield within 95 min
AllinOne (AiO)
Trasis
vendor cassetteHPLC+SPE20 ± 5%
yes
≥99%compound 2 (trimethyltin precursor)39398184
2024 ACS Omega
the whole process was automated on a kit-based AllInOne synthesizer for clinical applications — Ready-to-inject [18F]DTG was obtained in 20 ± 5% (n = 12) decay-corrected radiochemical yield within 90 min
TRACERlab FX N Pro
GE HealthCare
29% (conversion, not isolated RCY)compound 2 (trimethyltin precursor)39398184
2024 ACS Omega
Optimization of the reaction conditions ... was performed on a TRACERlab FX N Pro module — reducing the quantity of 2 to 2 mg resulted in a 29% conversion

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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); 2 article(s) with F-18. Stage set/updated at stage 23 from PMID 39398184: '[18F]DTG (∼2 GBq) was obtained with a molar activity of 59 ± 2 GBq/μmol at the time of injection and was suitable for human applications.'.