Tracers / [177Lu]Lu-FAPI-04

[177Lu]Lu-FAPI-04

Also written as [177Lu]Lu-FAPI-04; [Lu-177]Lu-FAPI-04; FAPI-04

Radionuclide: Lu-177 t½ 9585 min
Modality: Therapy
Production route: —
Stage: —
Syntheses indexed: 5

Preclinical only, no clinical indication yet

What it is

Compound class: FAPI-04 (fibroblast activation protein inhibitor, small-molecule FAP-targeting radioligand)
Target / mechanism: —
Clinical application: —
Theranostic pair: <a href="/tracers/ga68-fapi04/">ga68-fapi04</a>

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

Module	Cassette	Purification	Yield %	RCP %	Precursor / supplier	Source
Modular-Lab EAZY Eckert & Ziegler	vendor cassette	SPE	88% ± 3	≥ %99	FAPI-04 MedChemExpress	33864154 2021 EJNMMI Radiopharm Chem A fully automated synthesis of [177Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) — [177Lu]Lu-FAPI-04; 88% ± 3, [177Lu]Lu-FAPI-46; 86% ± 3
Modular-Lab EAZY	—	—	—	—	FAPI-04	34009498 2021 EJNMMI Radiopharm Chem Fully-automated synthesis of 177Lu labelled FAPI derivatives on the module modular lab-Eazy
—	—	—	—	—	—	39753366 2025 J Nucl Med
—	—	—	—	—	DOTA-FAPI-04	41934690 2026 Eur J Med Chem
—	—	—	—	—	FAPI-04	39626520 2025 Eur J Med Chem

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Quality control Derived from the published synthesis

Ph. Eur. monograph: —
USP monograph: —

AppearancepHRCP HPLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityOsmolalityMolar activityMetal impuritiesLu-177m

How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Lu-177 preparation -> Lu-177m content (rule); therapeutic radiopharmaceutical -> osmolality (rule); receptor ligand with a saturable target -> molar activity (rule)

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 Lu-177. Compound class inferred from precursor name (not stated outright) -- PMID 33864154: 'FAPI-04 (Purity ≥99%) was supplied from MedChemExpress LLC.'.