Tracer library / [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
- 41
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
- [177Lu]Lu-FAPI-46
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 decay-corrected | 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% decay-corrected | >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). |
| 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% decay-corrected | 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% decay-corrected | >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% decay-corrected | >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% decay-corrected | >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% decay-corrected | >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% decay-corrected | 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 |
| Manual synthesis | — | — | — | — | — | 42488187 2026 Iran J Pharm Res [68Ga]Ga-FAPI-46 (100 μL, 3.7 MBq; reference group) |
| — | — | — | — | >95% | DOTA-FAPI-46 | 42230823 2026 Sci Rep |
| 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). |
| — | — | SPE | — | 95–98% | FAPI-46 | 41762411 2026 EJNMMI Radiopharm Chem |
| EasyOne Trasis | vendor cassette | SPE | 91 decay-corrected | >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) |
| 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 |
| 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 |
| — | — | — | — | 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 |
| — | — | SPE | — | >95% | FAPI-46 Nanchang Tanzhen Biological Technology Co., Ltd., China | 40177850 2025 Mol Cancer Ther |
| 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. |
| iMiDEV PMB-Alcen | vendor cassette | SPE | 44 ± 5% decay-corrected | 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%. |
| miniAllinOne Trasis | — | SPE | — | — | FAPI-46 | 41698532 2026 Ann Pharm Fr The radiosynthesis of [68Ga]Ga-FAPI-46 was performed using a Trasis Mini AIO automated system. |
| iPHASE MultiSyn iPHASE Technologies | — | SPE | 89.8 ± 4.8% decay-corrected | — | — | 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. |
| Modular-Lab PharmTracer Eckert & Ziegler | — | HPLC | 91.1 ± 3.4 % decay-corrected | 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 % |
| Mortenon M1 vendor not confirmed -- see article | — | — | 70.63% ± 2.85% | >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 |
| EasyOne Trasis | — | — | 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% |
| GAIA Elysia-Raytest | — | — | — | — | FAPI-46 | 39603609 2024 Chem Pharm Bull (Tokyo) an automated method for preparing [68Ga]Ga-FAPI-46 was designed using a GAIA® synthesizer |
| — | — | — | — | >95% maximum 99.1% | FAPI-46 | 41742873 2026 Nucl Med Commun |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- Intra-patient comparison of tracer uptake and biodistribution of [68Ga]Ga-FAPI-46 and [18F]AlF-FAPI-74.2026 · Ann Nucl Med · Prospective
- Early post-infarct fibroblast activation protein-targeted PET/CT with 68Ga-FAPI-46 identifies STEMI patients with preserved LVEF at higher risk for adverse remodeling and cardiovascular events.2026 · Eur J Nucl Med Mol Imaging · Prospective
- FAP-Targeted Theranostics in Advanced Sarcoma: A Pilot Study of ⁶⁸Ga-FAPI-46 Imaging and ¹⁷⁷Lu-FAPI-2286 Therapy.2026 · Clin Nucl Med · Prospective
- Safety of [68Ga]Ga-FAPI-46 PET/CT including hemodynamic measurements and patient-reported outcomes in cancer patients.2026 · Clin Physiol Funct Imaging · Prospective
- Myocardial Fibroblast Activation in Ischemic and Nonischemic Cardiomyopathy.2026 · JAMA Cardiol · Prospective
- Feasibility of 68Ga-FAPI-46 PET for evaluating active fibrosis in aortic aneurysm.2026 · Sci Rep · Prospective
- Comparison between [68Ga]Ga-FAPI-46 and [18F]FDG PET/CT uptake in luminal-like vs. HER2-positive breast cancer.2026 · EJNMMI Res · Prospective
- Structure-guided design and clinical evaluation of 68Ga-GP01 for FAP-targeted PET imaging in solid tumors.2026 · J Control Release · Prospective
- FAP Expression in Renal Tumors Assessed by [68Ga]Ga-FAPI-46 PET Imaging and FAP Immunohistochemistry: A Case Series of Six Patients from the Prospective Exploratory Trial NCT04147494.2026 · J Nucl Med · Prospective
- [68Ga]FAPI PET/CT reveals increased pulmonary fibroblast activation protein expression in long COVID patients after ICU discharge.2025 · Eur J Nucl Med Mol Imaging · Prospective
Show all 34 clinical studies
- Fibroblast activation protein-targeted PET/CT with 68Ga-FAPI-46 for evaluation of structural damage and inflammation in axial spondyloarthritis: a prospective study.2025 · Eur J Nucl Med Mol Imaging · Prospective
- FAPI PET in inflammatory bowel disease: a novel window on fibroblast activity, with unanswered clinical questions.2026 · Expert Rev Gastroenterol Hepatol · Retrospective
- Initial Results of FAPI PET/MRI to Assess the Extent of Endometriosis.2026 · J Nucl Med · Retrospective
- Imaging tumor microenvironment: clinical experience with 68Ga-FAPI PET/CT across multiple cancer types.2026 · Q J Nucl Med Mol Imaging · Retrospective
- 90Y-FAPI-46 Radiopharmaceutical Therapy in Sarcoma and Other Solid Tumors: An Updated Cohort Analysis.2026 · J Nucl Med · Retrospective
- Detection of tumour heterogeneity in patients with advanced, metastatic castration-resistant prostate cancer on [68Ga]Ga-/[18F]F-PSMA-11/-1007, [68Ga]Ga-FAPI-46 and 2-[18F]FDG PET/CT: a pilot study.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- FAPI PET uptake patterns after invasive medical interventions: a single center retrospective analysis.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- Complementary Findings of 18 F-FDG and 68 Ga-FAPI-46 PET/CT in a Chronic Left Ventricular Aneurysm.2026 · Clin Nucl Med · Clinical study
- Kinetic modelling of [⁶⁸Ga]Ga-FAPI-46 PET in pancreaticobiliary lesions: distinguishing cancer from pancreatitis.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Repeatability of semi-quantitative [68Ga]Ga-FAPI-46 PET/CT measurements in pancreatobiliary cancers: a test-retest study.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Prognostic Value of Fibroblast Activation Protein-Directed PET Imaging in Pleural Mesothelioma.2026 · J Nucl Med · Clinical study
- Comparative analysis of 68Ga-FAPI-46 PET/CT and 18F-FDG PET/CT in advanced epithelial ovarian cancer: implications for preoperative scoring and treatment planning.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Early image acquisition 68Ga-FAPI-46-PET/CT in prone position is promising in the workup of rectosigmoid and anal carcinoma.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Synovial fibroblast activation occurs before the onset of rheumatoid arthritis and influences the risk of developing disease.2025 · RMD Open · Clinical study
- [68Ga]Ga-FAPI-46 PET accuracy for cancer imaging with histopathology validation: a single-centre, single-arm, interventional, phase 2 trial.2025 · Lancet Oncol · Clinical study · Phase II
- Multitracer comparison of gold standard PSMA-PET/CT with 68Ga-FAPI and 18F-FDG in high-risk prostate cancer: a proof-of-concept study.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Inflammatory 68 Ga FAPI-46 Uptake Mimicking a Sister Mary Joseph's Nodule in a Case of Gastric Signet Ring Cell Carcinoma.2025 · Clin Nucl Med · Clinical study
- 68Ga-FAPI and 18F-FAPI PET/CT for detection of nodal metastases prior radical cystectomy in high-risk urothelial carcinoma patients.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Squamous Cell Carcinoma of the Tonsil Unmasked by 68 Ga-FAPI-46 PET/CT.2025 · Clin Nucl Med · Clinical study
- Exploring currently available fibroblast activation protein targeting molecules in adrenocortical carcinoma: Navigating theranostic pathways.2025 · Eur J Nucl Med Mol Imaging · Clinical study
- Synthesis, Preclinical Evaluation, and a Pilot Clinical PET Imaging Study of 68Ga-Labeled FAPI Dimer.2022 · J Nucl Med · Clinical study
- Thyroiditis Induced by Immune Checkpoint Inhibitors Exhibits High [ 68 Ga]Ga-FAPI-46 and [ 18 F]FDG Uptake on PET/CT : A Case Report.2026 · Clin Nucl Med · Case report
- FAPI Uptake in Avascular Necrosis of the Talus.2026 · Clin Nucl Med · Case report
- 90Y-FAPI-46 Theranostics Leads to Near-Complete Metabolic Response in 3 Patients with Solitary Fibrous Tumors.2025 · J Nucl Med · Case report, multicentre
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, MedChemExpress, MedChemTronica, Sollentuna, Nanchang Tanzhen Biological Technology Co., Ltd., SOFIE
- Typical final purification
- SPE
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Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- no monograph none (general monograph 0125 applies)
- 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
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