Tracer library / [177Lu]Lu-FAPI-04

Structure of FAPI-04 (unlabelled parent compound, from PubChem) — Unlabelled parent compoundPubChem CID 138454803

[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: Clinical research
Syntheses indexed: 2

Preclinical only, no clinical indication yet

What it is

Compound class: FAPI-04 (fibroblast activation protein inhibitor, small-molecule FAP-targeting radioligand)
Target / mechanism: Fibroblast activation protein (FAP) PMID 36813980
Clinical application: Fibroblast activation protein-targeted radionuclide therapy in advanced-stage cancer patients PMID 33883494
Theranostic pair: [68Ga]Ga-FAPI-04

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

Precursor

Common precursor: —
Suppliers seen in the literature: —
Cited suppliers in indexed syntheses: MedChemExpress
Typical final purification: —

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Quality control Derived from the published synthesis

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 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.'. Stage set/updated at stage 39 from PMID 33883494: 'Four patients with metastatic advanced-stage cancer were administered low-dose 177Lu-FAPI04 for dosimetry measurements.'.