Tracers / [177Lu]Lu-PSMA-617
[177Lu]Lu-PSMA-617
Also written as 177Lu-PSMA-617; [177Lu]Lu-PSMA-617; [177Lu]Lu-PSMA617; [Lu-177]Lu-PSMA-617; Lu-177 PSMA-617; lutetium (177Lu) vipivotide tetraxetan; PSMA-617
- Radionuclide
- Lu-177 t½ 9585 min
- Modality
- Therapy
- Production route
- —
- Stage
- approved
- Syntheses indexed
- 96
What it is
- Compound class
- PSMA-617 (DOTA-conjugated urea-based PSMA-targeting small molecule ligand)
- Target / mechanism
- Targets prostate-specific membrane antigen (PSMA); binding results in internalisation and delivery of β-radiation into PSMA-expressing cancer cells PMID 37284895
- Clinical application
- PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer PMID 38725500
- Theranostic pair
- <a href="/tracers/ga68-psma11/">ga68-psma11</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 PharmTracer Eckert & Ziegler | vendor cassette | SPE | — | — | DOTA-PSMA ABX | 27090254 2016 EJNMMI Res 177Lu-radiolabelling was performed using the cassette-based ModularLab PharmTracer® synthesizer (EZAG, Berlin, Germany) |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | >90 % | 92 % | PSMA-617 ABX | 27090254 2016 EJNMMI Res Both kinds of synthesis was carried out with a Scintomics GRP synthesizer, sterile single use cassettes and the standard synthesis sequences for 68Ga-peptides respective therapeutic peptides. — The labelling to 177Lu-PSMA-617 was quantitative, there for the yield was >90 % |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | none | 91 ± 4 yes | 96.6 ± 0.7 | PSMA-617 ABX | 33067810 2021 J Labelled Comp Radiopharm iPHASE MultiSyn module — Formulated and sterile radiopharmaceuticals were obtained in 76 ± 3% (n = 20) and 91 ± 4% (n = 15) radiochemical yields after 17 and 20 min, respectively. |
| — | — | — | 99 | — | — | 31891883 2020 Nucl Med Biol |
| — Elysia-Raytest | vendor cassette | none | >96% no | >95% | PSMA-617 (vipovitide tetraxetan) MedChemExpress | 42287471 2026 EJNMMI Radiopharm Chem Radiopharmaceutical [177Lu]Lu-PSMA-617 was synthetized by the Gaia&Luna module (Elysia Raytest, Germany). — The radiopharmaceutical was obtained with > 95% radiochemical purity and > 96% radiochemical yield. |
| — | — | — | — | — | — | 40638023 2025 Ann Nucl Med |
| — | — | — | — | >95% | PSMA-617 MedChemExpress | 36145382 2022 Pharmaceuticals (Basel) |
| — | — | — | — | — | — | 41026359 2025 Int J Clin Oncol |
| — | — | — | — | — | — | 39293462 2024 Lancet |
| — | — | — | — | — | — | 40580320 2025 Eur J Nucl Med Mol Imaging |
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | SPE | 90.1 ± 0.8% | >99% TLC, >98% HPLC | PSMA-617 Gamma Servizi s.r.l., Pavia, Italy | 29097938 2017 Contrast Media Mol Imaging The ML Eazy system was also tested to prepare 90Y- and 177Lu-PSMA-617 — 90.1 ± 0.8% (n = 5), for yttrium-90 and lutetium-177, respectively, were achieved |
| Manual synthesis | — | SPE | 72 ± 6% no | >95% | PSMA-617 MedChemExpress | 42654126 2026 Pharmaceutics PSMA-617 (10 mM in DMSO), sodium acetate (0.4 M, pH 5.5), 20% ascorbic acid solution, and approximately 185-370 MBq of 177Lu-LuCl3 ... were combined in a reaction vial, and incubated at 95 °C for 60 min. — The non-decay-corrected radiochemical yield was 72 ± 6% |
| — Elysia-Raytest | vendor cassette | none | >96% no | >95% | PSMA-617 (vipovitide tetraxetan) MedChemExpress | 42287471 2026 EJNMMI Radiopharm Chem Radiopharmaceutical [177Lu]Lu-PSMA-617 was synthetized by the Gaia&Luna module (Elysia Raytest, Germany). — The radiopharmaceutical was obtained with > 95% radiochemical purity and > 96% radiochemical yield. |
| Kit-based preparation | — | — | — | 95.6 | — | 42287471 2026 EJNMMI Radiopharm Chem reference product (Pluvicto®) |
| Manual synthesis | — | — | — | — | DOTA-PSMA-617 ABX | 42274762 2026 Eur J Nucl Med Mol Imaging radiolabeling was performed in-house |
| Kit-based preparation Novartis | — | — | — | — | — Novartis | 42201380 2026 Eur J Nucl Med Mol Imaging [177Lu]Lu-PSMA-617 (Pluvicto™, Novartis) was administered intravenously |
| Manual synthesis | — | SPE | >95% | >98% | PSMA-617 Novartis | 42159963 2026 EJNMMI Radiopharm Chem In a 1.5 mL protein Eppendorf tube (LoBind®), approximately 37.0 MBq of 177LuCl3 in 0.25 M NaOAc buffer (pH 5.5, 100 µL) or 18.5 MBq of 212PbCl2 in 0.2 M NaOAc buffer (pH 5.5, 100 µL) was mixed with PSMA-617 (1.0 nmol, 1.0 µL). — isolated radiochemical yield of > 95% for [177Lu]Lu-PSMA-617 |
| — | — | — | — | — | — | 42138316 2026 Clin Transl Sci |
| — | — | — | — | — | — | 42013849 2026 Cell Rep Med |
| — | — | — | — | — | — | 41993992 2026 Front Endocrinol (Lausanne) |
| — | — | — | — | — | — | 41856667 2026 J Nucl Med |
| — | — | — | — | — | — | 41819830 2026 J Nucl Med |
| — | — | — | — | — | — | 41771032 2026 Clin Nucl Med |
| — | — | — | — | — | — | 41748296 2026 J Nucl Med |
| — | — | — | — | — | — | 41679922 2026 J Nucl Med |
| Kit-based preparation | — | — | — | — | — | 41610875 2026 Nuklearmedizin In-house preparations (using GMP-grade kits and in-house radiolabelling) |
| — | — | — | — | — | — | 41489652 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41448174 2026 Med Phys |
| Manual synthesis | — | — | — | — | PSMA-617 | 41407974 2026 Eur J Nucl Med Mol Imaging 37–187 MBq of 177LuCl3 was mixed with 10 µL of 0.5 M NaOAc (pH = 5.5) and incubated with AP-01 or PSMA-617 (10–20 µg) at 90 °C for 20 min, respectively |
| Kit-based preparation Novartis | — | — | — | — | PSMA-617 Novartis | 40897948 2025 Mol Imaging Biol [177Lu]Lu-PSMA-1-DOTA was labeled by 3D Imaging, LCC with clinical grade [177Lu]Lu-PSMA-617 (Pluvicto, Novartis) used as positive control for RLT. |
| — | — | — | — | — | — | 40724999 2025 Int J Mol Sci |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | — | 99 ± 5% no | 95.8 ± 1.6% (0h HPLC) | PSMA-617 ABX | 40696084 2025 EJNMMI Radiopharm Chem This process was automated using an iPHASE MultiSyn radiochemistry module with sterile kits affording sterile and apyrogenic 177Lu-labeled radiopharmaceuticals in non-decay corrected yields > 95%. — yielding 99 ± 5%. |
| — | — | — | — | — | — | 40638023 2025 Ann Nucl Med |
| Manual synthesis | — | — | — | — | PSMA-617 precursor MedChemExpress | 40049746 2025 J Nucl Med All radiopharmaceuticals were radiolabeled, formulated, and quality-controlled using optimized versions of previously described methods (15). |
| Manual synthesis | — | SPE | 99.5 ± 0.5% | >97% | PSMA-617 Jenguro Ltd., Moscow, Russia | 39771514 2024 Pharmaceutics The synthesis was carried out in Eppendorf Safe-Lock tubes (1.5, 2.0, or 5 mL) at temperatures of 24.5 (RT), 50, 75, 82, and 95 °C with Eppendorf ThermoMixer® C (Hamburg, Germany). — a nearly quantitative reaction yield (99.5 ± 0.5%) may be observed after 10 min of incubation even at ambient temperature (RT, 24.5 °C) |
| Manual synthesis CEM Corporation | — | — | 98.1 ± 1.2% | ≥97.5% | PSMA-617 Jenguro Ltd., Moscow, Russia | 39771514 2024 Pharmaceutics For microwave heating, the reaction was performed with a CEM Discover 908005 Microwave Synthesis System in Biotage® Microwave Reaction Vials (Uppsala, Sweden). — radiochemical yields of ~98% were achieved in 1 (98.1 ± 1.2%) and 5 (98.2 ± 1.1%) min at sodium acetate concentrations of 0.1 and 1.0 mol/L, respectively |
| — | — | — | — | — | — | 39753366 2025 J Nucl Med |
| Manual synthesis | — | — | over 90% | above 95% | PSMA-617 | 39563828 2024 ACS Med Chem Lett [177Lu]LuCl3, Na–Ac buffer (400 nM), pH = 5.0, 98 °C, 25 min. — radiochemical yield was over 90% |
| — | — | — | — | — | — | 39207485 2024 Eur J Nucl Med Mol Imaging |
| Manual synthesis | — | none | 94.29 ± 0.01% | 94.29 ± 0.01% | PSMA-617 | 39083135 2024 EJNMMI Radiopharm Chem 177Lu-PSMA-617 was prepared by successively adding 177LuCl3 solution (5 µL, 40.7 MBq), PSMA-617 (0.22 mmol/L, 30 µL, 6.7 nmol; prepared in 0.5 M HAc-NaAc buffer, pH 5.2), and gentisic acid (65.00 mmol/L, 40 µL, 2600 nmol) in a reaction flask. — 177Lu-PSMA-61795 ℃5.015 min94.29 ± 0.01%94.29 ± 0.01% |
| — | — | — | — | — | — | 38960712 2024 J Nucl Med |
| — | — | — | — | — | — | 38855174 2024 Theranostics |
| — | — | — | — | — | — | 38760451 2024 Sci Rep |
| Manual synthesis | — | — | — | — | PSMA-617 | 38725500 2024 Chem Sci The corresponding DOTA conjugates were labeled with 177Lu (compound 18 and Pluvicto™) |
| Manual synthesis | — | SPE | 90% | greater than 95% | PSMA-617 | 38700450 2024 Adv Healthc Mater PSMA-617 in water (25 μg per 25 μL) was added to 925 MBq of 177Lu in 250 μL 0.18 M ascorbic acid solution and the solution was shaken at 95 °C for 40 min — The isolated radiochemical yield after cartridge purification was 90%, with greater than 95% purity and molar activity was 41.68 MBq/nmol. |
| — | — | — | — | — | PSMA-617 | 38577331 2024 Front Oncol |
| — | — | — | — | — | — | 37861915 2023 Curr Oncol Rep |
| Manual synthesis | — | — | — | — | PSMA-617 precursor ABX | 37797974 2023 J Nucl Med Radiolabeling was performed as previously described |
| Manual synthesis | — | HPLC+SPE | — | — | PSMA-617 | 37649602 2023 Theranostics [177Lu]LuCl3 (~500 MBq in ~15 μL) was added to a solution of the DOTA-conjugated precursor (25 μg) in NaOAc buffer (0.5 mL, 0.1 M, pH 4.5). The mixture was incubated at 90 °C for 15 min |
| Manual synthesis | — | — | — | — | PSMA-617 ABX | 37284895 2023 Naunyn Schmiedebergs Arch Pharmacol PSMA-617 (60 µg) mixed with 740 µl of gentensic solution (3 mg/ml dissolved in 0.4 M sodium acetate, pH = 4.6) was added to 163 µl of the 177LuCl3 solution. The buffered solution was heated for 20 min at 92 °C and diluted with saline to reach a final activity of 1 GBq/ml. |
| — | — | — | — | ≥ 97% | PSMA-617 | 37246997 2023 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 36759199 2023 J Nucl Med |
| — | — | HPLC | — | — | PSMA-617 | 36168623 2022 Theranostics |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | — | — | PSMA-617 ABX | 36166155 2022 EJNMMI Radiopharm Chem [177Lu]Lu-PSMA-I&T and [177Lu]Lu-PSMA-617 was produced with a Scintomics GRP module |
| Manual synthesis | — | none | — | ≥ 98% | PSMA-617 | 35635566 2022 Eur J Nucl Med Mol Imaging The radiolabeling of the PSMA ligands with lutetium-177 (no-carrier-added; in 0.04 M HCl; ITM Medical Isotopes GmbH, Germany) was performed under standard labeling conditions at pH 4.5 as previously reported |
| Manual synthesis | — | — | — | >95% | PSMA-617 precursor | 35086894 2022 J Nucl Med 177Lu labeling of PSMA ligands according to standard manual procedures resulted in a radiochemical purity of more than 95% |
| Manual synthesis | — | — | >98 | >98 | PSMA-617 ABX | 34932154 2022 Eur J Nucl Med Mol Imaging For the biodistribution study, 18 µg PSMA ligand (15 nmol PSMA-617, 12 nmol PSMA-I&T) was added to 0.5 M MES buffer, pH 5.5, and 33 MBq [177Lu]LuCl3 — Radiolabeling of PSMA-617 and PSMA-I&T with [177Lu]LuCl3 resulted in radiochemical yield of > 98% |
| — | — | — | — | — | — | 34887335 2022 J Nucl Med |
| Manual synthesis | — | none | — | ≥ 95% | PSMA-617 | 34402925 2022 Eur J Nucl Med Mol Imaging The radiolabeling of Ibu-DAB-PSMA and PSMA-617 was performed under standard labeling conditions at pH 4.5 using lutetium-177 |
| — | — | — | — | — | — | 33840558 2021 Eur Urol |
| — | — | — | — | — | PSMA-617 | 33778927 2021 Curr Oncol Rep |
| Manual synthesis | — | — | — | — | PSMA-617 ABX | 33579037 2021 Biomolecules Radiolabeling was conducted as previously described by Kratochwil et al. [34]. 1 GBq of non-carrier added Lutetium-177 (ITG GmbH, Garching, Germany), 30–40 MBq/µL, was mixed with 100 µL sterile 0.4 M sodium acetate solution, pH 5.5, and 1.25 µL 20% w/w ascorbic acid solution; thereafter, 2 µL of a 10 mM solution of PSMA-617 (ABX, Radeberg, Germany) was added. |
| — | — | — | — | — | — | 33465252 2021 Prostate |
| Manual synthesis | — | — | >95% | >90% | PSMA-617 Advanced Biochemical Compounds, ABX, Germany | 33094433 2021 Eur J Nucl Med Mol Imaging Labeling of PSMA-617, PSMA-I&T, and JVZ-007 was performed as previously described — For all labelings, the radiochemical yield was > 95% and the radiochemical purity was > 90%. |
| — | — | — | — | — | — | 31940969 2020 Pharmaceuticals (Basel) |
| Manual synthesis | — | — | 99% | — | — | 31891883 2020 Nucl Med Biol labeling yield of [177Lu]Lu-PSMA-617 was measured as a function of reaction time by sampling 2 μL crude product (925 kBq/μL) at different time points and spotting on a TLC plate — high labeling efficiency (99%) can be achieved in just 10 min |
| Manual synthesis | — | HPLC | >98% | >99% | — | 31399803 2019 Eur J Nucl Med Mol Imaging All compounds were synthesized using solution-phase chemistry based on our well-established methods — All ligands were radiolabeled with 177Lu in high radiochemical yield (> 98%) and purity (> 99%) using both conventional and microwave-assisted methods. |
| Manual synthesis | — | — | — | — | PSMA-617 | 31107537 2019 Mutagenesis 177Lu labelling of PSMA-617 was performed as described (11). |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | — | — | DOTA-PSMA ABX | 27090254 2016 EJNMMI Res 177Lu-radiolabelling was performed using the cassette-based ModularLab PharmTracer® synthesizer (EZAG, Berlin, Germany) |
| — | — | — | 98% | — | PSMA-617 | 40425733 2026 Nat Protoc |
| — | — | — | — | — | — | 41006727 2025 Med Oncol |
| — | — | — | — | — | — | 40908334 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 42705104 2026 Biomed Pharmacother |
| — | — | — | — | — | — | 42624649 2026 J Nucl Med |
| — | — | — | — | — | — | 42565339 2026 J Med Econ |
| — | — | — | — | — | — | 42561994 2026 Lancet |
| — | — | — | — | — | — | 42509121 2026 Eur Urol Focus |
| — | — | — | — | — | — | 42472416 2026 Ann Biomed Eng |
| — | — | — | — | — | — | 42437859 2026 Discov Oncol |
| — | — | — | — | — | — | 42418373 2026 J Med Chem |
| — | — | — | — | — | PSMA-617 | 42407347 2026 Bioorg Chem |
| — | — | — | — | — | — | 42320339 2026 Cancer Treat Res Commun |
| — | — | — | — | — | — | 42263768 2026 ACS Nano |
| — | — | — | — | — | — | 42156554 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | PSMA-617 | 42126983 2026 J Med Chem |
| — | — | — | — | — | — | 42049456 2026 J Nucl Med Technol |
| — | — | — | — | — | — | 41986500 2026 Nat Cancer |
| — | — | — | — | — | — | 41849022 2026 Ann Nucl Med |
| — | — | — | — | — | — | 41748297 2026 J Nucl Med |
| — | — | — | — | — | — | 41575546 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | 99% | — | 40494649 2025 Mol Pharm |
| — | — | — | — | — | PSMA-617 | 39332777 2024 J Control Release |
| — | — | — | — | — | — | 35895995 2022 Mol Pharm RIMS-1 was generated using a convergent synthesis employing solid phase peptide and solution chemistries |
| — | — | — | — | — | — | 34714082 2021 Mol Pharm |
| — | — | — | — | — | — | 33581798 2021 Lancet |
| — | — | — | — | — | — | 31227054 2019 Semin Nucl Med |
Need this precursor?We can point you to suppliers for [177Lu]Lu-PSMA-617, 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. Lu-177m content + metal impurities + molar activity + osmolality per rules (therapeutic radiometal, saturable target). HPLC essential for radiolysis products (draft note retained).
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 [177Lu]Lu-PSMA-617.
Get in touchNotes
Stage 8: PSMA-617 radioligand therapy agent. 7 corpus articles with Lu-177 were collapsed onto the In-111 anchor [111In]In-PSMA-617 by the isotope-blind key (PMID 42287471, 41249585, 41026359, 40908334, 39293462, 38512591, 34964165). Added as its own row. Theranostic hub: also paired (one-way) from f18-psma1007, f18-dcfpyl, in111-psma617 -- ga68-psma11 (Locametz/gozetotide) is the FDA-approved companion diagnostic for Lu-177-PSMA-617 (Pluvicto); the other three are additional PSMA-targeting diagnostics used with the same therapeutic in practice, not tracked back here to avoid a many-valued field. [stage 19] Compound class inferred from precursor name (not stated outright) -- PMID 27090254: 'The ligand PSMA-617 was purchased from ABX.'. Stage set/updated at stage 23 from PMID 38725500: 'Pluvicto™ is a PSMA-targeted radioligand therapeutic (RLT) recently approved by the FDA for the treatment of metastatic castration-resistant prostate cancer (2022 FDA marketing authorization).'.