Tracers / [177Lu]Lu-FAPI-46

[177Lu]Lu-FAPI-46

Also written as 177Lu-FAPI-46; [177Lu]Lu-FAPI-46; [Lu-177]Lu-FAPI-46
Radionuclide
Lu-177 t½ 9585 min
Modality
Therapy
Production route
Stage
Syntheses indexed
9

What it is

Compound class
FAP inhibitor (FAPI) small-molecule radioligand, DOTA-conjugated
Target / mechanism
Targets fibroblast activation protein (FAP), expressed on cancer-associated fibroblasts and tumor cells PMID 40177850
Clinical application
Theranostic pair
<a href="/tracers/ga68-fapi46/">ga68-fapi46</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

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
Modular-Lab EAZY
Eckert & Ziegler
vendor cassettenone95 ± 1.0 (synthesis no. 3-5)99.8 (radio-HPLC, synthesis no.3)FAPI-46
ABX
37233924
2023 EJNMMI Radiopharm Chem
ModularLab EAZY (Eckert & Ziegler Eurotope GmbH, Berlin, Germany) — we increased the balanced radiochemical yield from 86.0% ± 1.4% (synthesis no 1 and 2) to 95% ± 1.0% (synthesis no. 3–5)
Modular-Lab EAZY
Eckert & Ziegler
vendor cassetteSPE86% ± 3≥ %99FAPI-46
ABX
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 EAZYFAPI-4634009498
2021 EJNMMI Radiopharm Chem
Fully-automated synthesis of 177Lu labelled FAPI derivatives on the module modular lab-Eazy
FAPI-4642242868
2026 J Nucl Med
Manual synthesisSPEDOTA-FAPI-4641688618
2026 EJNMMI Res
FAPI-46 and FAP-2286 were radiolabeled with 111In and 177Lu at a selected pH for 10 min at 100 °C, then purified with a SepPak cartridge
Manual synthesisSPE>95%FAPI-46
Nanchang Tanzhen Biological Technology Co., Ltd., China
40177850
2025 Mol Cancer Ther
[177Lu]LuCl3 (185–740 MBq) was mixed with 0.2 mL of 0.5 mol/L NaOAc (pH = 5.5) and incubated with FAPI-46, DOTA-LP, DOTA-ALB-01, DOTA-ALB-02, and DOTA-ALB-03 (20 μg) at 95°C for 15 minutes.
Manual synthesisSPE>90%>95%FAPI-4637321827
2023 J Nucl Med
For 177Lu labeling, each of the aforementioned precursors was dissolved in 1 mL of NaAc (0.25 M in water) and added to 4 mL of 177LuCl3 solution (740 MBq in 0.05 M HCl). — 68Ga, 64Cu, and 177Lu were labeled in more than 90% yield with radiochemical purity of more than 95%.
Manual synthesis≥ 93%FAPI-4637261473
2023 Eur J Nucl Med Mol Imaging
177Lu-labeling was performed at different conditions, depending on the ligand (Supplementary Table 1).
Modular-Lab EAZY
Eckert & Ziegler
vendor cassettenone95 ± 1.099.8FAPI-46
ABX
37233924
2023 EJNMMI Radiopharm Chem
All three radiopharmaceuticals were successfully synthesized in high radiochemical purities and yields on the ML Eazy. — we increased the balanced radiochemical yield from 86.0% ± 1.4% (synthesis no 1 and 2) to 95% ± 1.0% (synthesis no. 3–5)

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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

Stage 8: 1 corpus article with Lu-177 FAPI-46 (PMID 37233924) was collapsed onto the Ga-68 anchor [68Ga]Ga-FAPI-46. Added as the therapy partner of the FAPI-46 anchor. Compound class inferred from precursor name (not stated outright) -- PMID 41688618: '[177Lu]Lu-DOTA-FAPI-46'.