Tracers / [18F]OP-801

[18F]OP-801

Also written as [18F]OP-801; [F-18]OP-801
Radionuclide
F-18 t½ 109.77 min
Modality
PET
Production route
—
Stage
phase 1/2 clinical trial (first-in-human)
Syntheses indexed
1
NeuroinflammationAmyotrophic lateral sclerosis / motor neuron disease

What it is

Compound class
PAMAM-G4 dendrimer conjugate
Target / mechanism
Selectively taken up by reactive microglia and macrophages PMID 37310119
Clinical application
PET imaging of reactive microglia and macrophages in neuroinflammatory diseases PMID 37310119
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 FN
GE HealthCare
custom manifoldHPLC+SPE6.89%
yes
99%PAMAM-G4-OH alkyne10 dendrimer precursor and 3-azidopropyl-4-methylbenzenesulfonate
Snapdragon Chemistry
37310119
2023 ACS Chem Neurosci
All chemistry was performed on a TRACERlab FX–FN synthesis module (GE) with an adjacent custom synthesis platform (built in-house) and a remote control HPLC column selector (Cheminert 6 port, VICI) — average of 6.89% (SD 2.23) decay corrected radiochemical yield

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Quality control Preliminary — inferred from compound class

Ph. Eur. monograph
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USP monograph
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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); 1 article(s) with F-18. Compound class inferred from precursor name (not stated outright) -- PMID 37310119: 'polyamidoamine generation 4 hydroxyl alkyne (10) dendrimer (PAMAM-G4-OH alkyne10)'. Stage set/updated at stage 23 from PMID 37310119: 'a phase 1/2 clinical trial (NCT05395624) for first-in-human imaging in healthy controls and patients with amyotrophic lateral sclerosis is underway'. | Stage 28: added indication(s) neu-als from consolidated missing-rubric review.