Tracers / [68Ga]Ga-FAPI-46
[68Ga]Ga-FAPI-46
Also written as [68Ga]FAPI-46; [68Ga]Ga-FAPI-46; [Ga-68]FAPI-46; [Ga-68]Ga-FAPI-46; FAPI-46; Ga-68 FAPI-46; Ga-68-FAPI-46
- Radionuclide
- Ga-68 t½ 67.7 min
- Modality
- PET
- Production route
- Generator / Cyclotron liquid target
- Stage
- Clinical research
- Syntheses indexed
- 77
What it is
- Compound class
- Small molecule (quinoline)
- Target / mechanism
- Fibroblast activation protein (FAP) PMID 30850501 / DOI 10.2967/jnumed.118.224469
- Clinical application
- Broad oncology imaging (many carcinomas); also non-oncologic fibrosis and inflammation PMID 36594838 / DOI 10.1148/radiol.220749
- Theranostic pair
- <a href="/tracers/lu177-fapi46/">lu177-fapi46</a>
Regulatory status
- FDA
- No Drugs@FDA / openFDA drug registry — no approved application found; search: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=FAPI-46
- EMA (centralised)
- —
- Other approvals
- —
- Brand names
- —
Clinical use
- Typical injected activity
- 80-200 MBq (most common across FAPI PET studies) PMID 38052711 / DOI 10.1053/j.semnuclmed.2023.11.003
- Uptake time
- ~60 min post-injection (imaging feasible earlier, <30 min, for FAPI-46) PMID 38052711 / DOI 10.1053/j.semnuclmed.2023.11.003
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| iMiDEV PMB-Alcen | vendor cassette | SPE | 44 ± 5 yes | 97.7 ± 0.5% (HPLC) | FAPI-46 MedChemTronica, Sollentuna, Sweden | 38091157 2023 EJNMMI Radiopharm Chem Microfluidic-based production of [68Ga]Ga-FAPI-46 and [68Ga]Ga-DOTA-TOC using the cassette-based iMiDEV™ microfluidic radiosynthesizer — The radiochemical yielddc (RCYdc) of [68Ga]Ga-FAPI-46 was 44 ± 5% (n = 3) |
| iMiDEV PMB-Alcen | vendor cassette | SPE | 42 ± 6 | ≥ 95% | FAPI-46 MedChemTronica, Sollentuna, Sweden | 38091157 2023 EJNMMI Radiopharm Chem it was repeated at Nancyclotep (radiochemistry laboratory) using the same experimental settings as the validation runs — The pulse flow approach allowed us to obtain [68Ga]Ga-FAPI-46 with 42 ± 6% (n = 3) radiochemical yield and high radiochemical purity (≥ 95%). |
| EasyOne Trasis | vendor cassette | SPE | 91 ± 5% yes | >99.7% | FAPI-46 SOFIE | 41701433 2026 EJNMMI Radiopharm Chem a standard EasyOne module — The corrected yield of the labelled products was 91 ± 5% (72 ± 5% non-decay corrected). |
| — Sofie Biosciences | — | — | — | — | — SOFIE | 40272498 2025 Eur J Nucl Med Mol Imaging |
| miniAllinOne Trasis | vendor cassette | SPE | 89.4 ± 0.4 | 99.2 ± 0.1 | FAPI-46 precursor SOFIE | 39076612 2024 Front Chem an automated radiosynthesis of [68Ga]Ga-FAPI-46 on the Trasis miniAllinOne synthesizer — Radiochemical yield (%)n.r89.5 ± 2.691.9 ± 1.589.4 ± 0.4 |
| miniAllinOne Trasis | vendor cassette | SPE | 89.5 ± 2.6 | 99.6 ± 0.2 | FAPI-46 precursor SOFIE | 39076612 2024 Front Chem on the Trasis miniAllinOne (miniAIO) module — Radiochemical yield (%)n.r89.5 ± 2.691.9 ± 1.589.4 ± 0.4 |
| miniAllinOne Trasis | vendor cassette | SPE | 91.9 ± 1.5 | 99.2 | FAPI-46 precursor SOFIE | 39076612 2024 Front Chem on the miniAIO — Radiochemical yield (%)n.r89.5 ± 2.691.9 ± 1.589.4 ± 0.4 |
| EasyOne Trasis | vendor cassette | SPE | — | 99.3 ± 0.2 | FAPI-46 precursor SOFIE | 39076612 2024 Front Chem The radiosynthesis of [68Ga]Ga-FAPI-46 was performed on the Trasis EasyOne and miniAllinOne synthesizer — Radiochemical yield (%)n.r |
| FASTlab 2 GE HealthCare | custom manifold | SPE | — | 95.31, 95.24, 96.40 | DOTA-FAPI-46 SOFIE | 37843670 2023 EJNMMI Radiopharm Chem The GE FASTlab 2 automated radiosynthesis module was used with the developer control software. |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 72.6 ± 4.9% yes | 97.6 ± 0.3% | FAPI-46 precursor SOFIE | 37631053 2023 Pharmaceuticals (Basel) The radiolabelling was carried out on a Scintomics GRP module (Fürstenfeldbruck, Germany). — the average decay-corrected radiochemical yield was 72.6 ± 4.9%. |
| EasyOne Trasis | vendor cassette | SPE | 92.45% yes | >99.4% | FAPI-46 SOFIE | 35904684 2022 EJNMMI Radiopharm Chem employing a Trasis EasyOne synthesizer — Trasis GalliaPharm Acetate 99.4% 92.45% |
| Synthra GaSy Synthra | custom manifold | SPE | 92.86% yes | >99.8% | FAPI-46 SOFIE | 35904684 2022 EJNMMI Radiopharm Chem the GaSy module from Synthra with a customized synthesis template and a customized single use cassette — Synthra GalliaPharm HEPES 99.8% 92.86% |
| Scintomics GallElut Scintomics | fixed tubing | SPE | 93.3% yes | >99.7% | FAPI-46 SOFIE | 35904684 2022 EJNMMI Radiopharm Chem the automatic synthesis of [68Ga]Ga-FAPI-46 was established on a GallElut synthesis module from Scintomics with fixed tubing — Scintomics iThemba HEPES 99.7% 93.3% |
| AllinOne (AiO) Trasis | vendor cassette | SPE | 66.0 ± 7.6% yes | >98% | FAPI-46 SOFIE | 35163938 2022 Molecules Trasis AllinOne (AiO)™ (Trasis, Ans, Belgium) — RCY (decay corrected at the beginning of reaction): 66.0 ± 7.6 % (n = 10) |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | 57% | >95% | FAPI-46 SOFIE | 34439784 2021 Biomolecules Automated radiosynthesis was performed on an Eckert & Ziegler Modular-Lab PharmTracer synthesis module using the Modular-Lab software (Eckert & Ziegler). — RCYs of 57% and 64% were obtained for [68Ga]Ga-FAPI-46 and [68Ga]Ga-DOTATOC, respectively. |
| Modular-Lab PharmTracer Eckert & Ziegler | custom manifold | none | 95.2 ± 1.4 | 99.7% | FAPI-46 ABX | 33331982 2020 EJNMMI Radiopharm Chem Modular Lab PharmTracer (MLPT) — 5096.0 ± 0.62.1 ± 0.80.5 ± 0.10.5 ± 0.20.9 ± 0.295.2 ± 1.4 |
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | none | 89.7 ± 6.7 | 99.7% | FAPI-46 ABX | 33331982 2020 EJNMMI Radiopharm Chem Modular Lab eazy (ML eazy) — 5089.7 ± 6.76.1 ± 5.50.0 ± 0.00.5 ± 0.13.7 ± 1.4 |
| Modular-Lab PharmTracer Eckert & Ziegler | — | HPLC+SPE | 87.9 ± 1.3% | 98.34 ± 0.82 | FAPi-46 MedChemExpress | 42075850 2026 Pharmaceuticals (Basel) radiolabeling was performed using an automated synthesis module (Lab PharmTracer, Eckert & Ziegler, Berlin, Germany) — Automated synthesis of [68Ga]Ga-FAPi-46 achieved a high radiochemical yield (87.9 ± 1.3%) |
| Synthera IBA | vendor cassette | SPE | 90.53% yes | 98.94 ± 0.72% | FAPI-46 ABX | 37894781 2023 Int J Mol Sci IBA Synthera® Extension module — with values of 90.53% and 98.94% using radio-High-Performance Liquid Chromatography (radio-HPLC) respectively |
| — | — | — | — | — | FAPI-46 precursor U. Haberkorn, Heidelberg, Germany | 34957527 2022 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41824221 2026 EJNMMI Res |
| Manual synthesis | — | — | — | — | — | 42488187 2026 Iran J Pharm Res [68Ga]Ga-FAPI-46 (100 μL, 3.7 MBq; reference group) |
| — | — | — | — | — | — | 42478500 2026 Mol Pharm |
| — | — | — | — | — | — | 42318157 2026 Oncol Rev |
| — | — | — | — | — | FAPI-46 | 42242868 2026 J Nucl Med |
| — | — | — | — | >95% | DOTA-FAPI-46 | 42230823 2026 Sci Rep |
| — | — | — | — | — | FAPI-46 precursor SOFIE | 42086826 2026 Eur J Nucl Med Mol Imaging |
| Modular-Lab PharmTracer Eckert & Ziegler | — | HPLC+SPE | 87.9 ± 1.3% | 98.34 ± 0.82 | FAPi-46 MedChemExpress | 42075850 2026 Pharmaceuticals (Basel) radiolabeling was performed using an automated synthesis module (Lab PharmTracer, Eckert & Ziegler, Berlin, Germany) — achieved a high radiochemical yield (87.9 ± 1.3%) |
| Manual synthesis | — | — | 97.5% | — | FAPI-46 | 42010411 2026 J Nanobiotechnology a bleomycin-induced lung fibrosis model was used. 7 days after bleomycin instillation, mice were intravenously injected with each treatment — The labeling efficiency of [68Ga]Ga-FAPI-46 reached 97.5% (Fig. S4D). |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | — | approximately 90% yes | >93% | FAPI-46 GMP-grade precursor SOFIE | 42002985 2026 Clin Physiol Funct Imaging an automated Modular‐Lab PharmTracer synthesis module (Eckert & Ziegler) — yielded approximately 90% [⁶⁸Ga]Ga‐FAPI‐46 (decay‐corrected) |
| — | — | — | — | — | — | 41984469 2026 JAMA Cardiol |
| — | — | — | — | — | — | 41871918 2026 RMD Open |
| — | — | — | — | — | — | 41851386 2026 Sci Rep |
| — | — | SPE | — | 95–98% | FAPI-46 | 41762411 2026 EJNMMI Radiopharm Chem |
| EasyOne Trasis | vendor cassette | SPE | 91 yes | >99.7% | FAPI-46 peptide SOFIE | 41701433 2026 EJNMMI Radiopharm Chem a standard EasyOne module — The corrected yield of the labelled products was 91 ± 5% (72 ± 5% non-decay corrected) |
| — | — | — | — | — | — | 41599688 2026 Pharmaceuticals (Basel) |
| — | — | — | — | — | — | 41540241 2026 Eur J Nucl Med Mol Imaging |
| Modular-Lab Standard Eckert & Ziegler | vendor cassette | SPE | 87.69±5.96 | 97.17±0.68 | FAPi-46 | 41370506 2025 Einstein (Sao Paulo) A Modular-Lab Standard synthesis module (Eckert & Ziegler, Berlin, Germany) was successfully installed and implemented in November 2013 — Labeling Yield (%)89.03±3.7894.31±6.1881.31±0.3187.69±5.96 |
| — | — | — | — | — | — | 41314671 2025 RMD Open |
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | SPE | — | >95% | FAPI-46 ABX | 41155591 2025 Pharmaceuticals (Basel) The radiolabeling of [68Ga]Ga-FAPI-46 is performed using Modular-Lab Eazy Synthesizer (Eckert & Ziegler Radiopharma GmbH, Berlin, Germany) in Laboratory 1 |
| miniAllinOne Trasis | vendor cassette | SPE | — | >95% | FAPI-46 ABX | 41155591 2025 Pharmaceuticals (Basel) Mini AllinOne-MiniAIO (Trasis SA, Ans, Belgium) in Laboratory 2 |
| — | — | — | — | — | — | 41101974 2026 J Nucl Med |
| — | — | — | — | 99.3% ± 0.2% | FAPI-46 | 40935615 2025 J Nucl Med |
| Manual synthesis | — | — | — | — | FAPI-46 | 40841501 2025 EJNMMI Radiopharm Chem FAPI-46 was synthesized by following the literature |
| — | — | — | — | — | FAPI-46 precursor GE HealthCare | 40542858 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40349083 2025 Syst Rev |
| — Sofie Biosciences | — | — | — | — | — | 40272498 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 40263181 2025 Mol Diagn Ther |
| — | — | — | — | — | — | 40263181 2025 Mol Diagn Ther |
| — | — | SPE | — | >95% | FAPI-46 Nanchang Tanzhen Biological Technology Co., Ltd., China | 40177850 2025 Mol Cancer Ther |
| — | — | — | — | — | — | 39956945 2025 J Cachexia Sarcopenia Muscle |
| Manual synthesis | — | SPE | — | >95% | FAPI-46 | 39800373 2025 J Immunother Cancer approximately 25 nmol of FAPI-46 and DOTA-2P(FAPI)2 was dissolved in 1 mL of NaAc (0.25 M aqueous solution), and 4 mL of 68GaCl3 solution (1.1 GBq, dissolved in 0.05 M HCl) was added |
| Manual synthesis | — | SPE | — | >99% | FAPI-46 | 39770488 2024 Pharmaceuticals (Basel) During the labeling process, the generator was rinsed with 2 mL of 0.05 M HCl, and the waste solution was discarded. |
| — | — | — | — | — | — | 39207485 2024 Eur J Nucl Med Mol Imaging |
| iMiDEV PMB-Alcen | vendor cassette | SPE | 44 ± 5% yes | 97.7 ± 0.5% (HPLC) | FAPI-46 MedChemTronica, Sollentuna, Sweden | 38091157 2023 EJNMMI Radiopharm Chem Microfluidic cassette-based iMiDEV™ radiosynthesizer — The radiochemical yielddc (RCYdc) of [68Ga]Ga-FAPI-46 was 44 ± 5% (n = 3) |
| Manual synthesis | — | SPE | >90% | >95% | FAPI-46 | 37321827 2023 J Nucl Med For 68Ga labeling, approximately 25.4 nmol of FAPI-46, DOTA-2P(FAPI)2, or DOTA-4P(FAPI)4 were dissolved in 1 mL of NaAc (0.25 M in water) and added to 4 mL of 68GaCl3 solution (1.3 GBq in 0.05 M HCl). — 68Ga, 64Cu, and 177Lu were labeled in more than 90% yield with radiochemical purity of more than 95%. |
| — | — | SPE | — | more than 95% | FAPI-46 | 34556528 2022 J Nucl Med |
| — | — | SPE | — | — | FAPI-46 | 41698532 2026 Ann Pharm Fr The radiosynthesis of [68Ga]Ga-FAPI-46 was performed using a Trasis Mini AIO automated system. |
| — | — | SPE | 89.8 ± 4.8% yes | — | — | 38856210 2024 J Vis Exp using the iPHASE MultiSyn synthesizer for clinical applications — The product was synthesized in 89.8 ± 4.8% decay corrected yield (n = 6) over 25 min. |
| — | — | HPLC | 91.1 ± 3.4 % yes | 99.8 ± 0.3 % | FAPI-46 precursor | 39999572 2025 Nucl Med Biol [68Ga]Ga-FAPI-46 production on a Modular-Lab PharmTracer platform for clinical application — resulted in a decay-corrected yield of 91.1 ± 3.4 % and radiochemical purity of 99.8 ± 0.3 % |
| — | — | — | 70.63% ± 2.85% | above 99% | — | 38145430 2024 Ann Nucl Med full-automatic cassette-based synthesis module system Mortenon M1 for synthesis of radiopharmaceuticals — [68Ga]-FAPI-46, 70.63% ± 2.85%, n = 10 |
| — | — | — | 88 ± 7% | >99% | FAPI-46 | 35533534 2022 Nucl Med Biol the cassette based synthesis module Trasis EASYONE — a radiochemical yield of 88 ± 7% and 56 ± 5% |
| — | — | — | — | — | — | 40774265 2025 Lancet Oncol |
| — | — | — | — | — | FAPI-46 | 39603609 2024 Chem Pharm Bull (Tokyo) an automated method for preparing [68Ga]Ga-FAPI-46 was designed using a GAIA® synthesizer |
| — | — | — | — | — | — | 42627578 2026 Ann Nucl Med |
| — | — | — | — | — | — | 42477144 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42341206 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42253206 2026 Expert Rev Gastroenterol Hepatol |
| — | — | — | — | — | — | 42242866 2026 J Nucl Med |
| — | — | — | — | — | — | 42172798 2026 Bioorg Chem |
| — | — | — | — | — | — | 42080808 2026 Clin Nucl Med |
| — | — | — | — | — | — | 42018345 2026 Clin Exp Rheumatol |
| — | — | — | — | — | — | 41949416 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41854637 2026 Q J Nucl Med Mol Imaging |
| — | — | — | — | >95%, maximum 99.1% | FAPI-46 | 41742873 2026 Nucl Med Commun |
| — | — | — | — | — | — | 41642049 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41506801 2026 J Nucl Med |
Precursor
- Common precursor
- FAPI-46 conjugate PMID 33331982 / DOI 10.1186/s41181-020-00112-x
- Suppliers seen in the literature
- FAPI-46 precursor from SOFIE Biosciences (Dulles, VA, USA) (also cited as manufactured by ABX); FASTlab cassettes/reagents from ABX (Radeberg, Germany)
- Cited suppliers in indexed syntheses
- ABX, GE HealthCare, MedChemExpress, MedChemTronica, Sollentuna, Nanchang Tanzhen Biological Technology Co., Ltd., SOFIE, U. Haberkorn
- Typical final purification
- SPE
Need this precursor?We can point you to suppliers for [68Ga]Ga-FAPI-46, or handle the enquiry for you.
Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- no specific monograph
- USP monograph
- not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. No monograph — base set per Ph. Eur. 0125 + rule-based. Ge-68 breakthrough + metal impurities: generator Ga-68 only. RECOMMEND ADD: molar activity (saturable FAP target).
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [68Ga]Ga-FAPI-46.
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