Tracer library / [177Lu]Lu-PSMA-I&T
[177Lu]Lu-PSMA-I&T
Also written as [177Lu]Lu-PSMA-I&T
- Radionuclide
- Lu-177 t½ 9585 min
- Modality
- Therapy
- Production route
- —
- Stage
- Clinical research
- Syntheses indexed
- 20
What it is
- Compound class
- Radiolabelled PSMA-targeting urea-based peptidomimetic (I&T = imaging-and-therapy ligand)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA) PMID 26089548
- Clinical application
- PSMA-targeted radioligand therapy in metastatic castration-resistant prostate cancer PMID 26089548
- Theranostic pair
- [68Ga]Ga-PSMA-I&T
Regulatory status
- FDA
- No FDA (Drugs@FDA/openFDA): no PSMA-I&T product found (distinct from the approved PSMA-617/vipivotide and PSMA-11/gozetotide products)
- EMA (centralised)
- No EMA medicines register export (2026-09-09): no 'PSMA-I&T' entry
- Other approvals
- —
- Brand names
- —
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | none | 96.3 ± 2.1 synthesis no. 2-4 | — | PSMA-I&T piCHEM, Raaba-Grambach, Austria | 37233924 2023 EJNMMI Radiopharm Chem ModularLab EAZY (Eckert & Ziegler Eurotope GmbH, Berlin, Germany) - we increased the balanced radiochemical yield from 78 to 96.3% ± 2.1% (synthesis no. 2–4) |
| — Elysia-Raytest | vendor cassette | none | 97.2 ± 2.4% not corrected | 99.3 ± 0.6% | PSMA-I&T ligand ITM | 42154134 2026 EJNMMI Radiopharm Chem The [177Lu]Lu-PSMA I&T was produced using Elysia-Raytest's GAIA/LUNA synthesis modules. - a radiochemical yield of 97.2 ± 2.4% (without decay correction) was obtained |
| — | — | HPLC | 95% | 93-95% | PSMA I&T Technical University Munich | 27162555 2016 Theranostics |
| — | vendor cassette | none | 97.2 ± 2.4% not corrected | 99.3 ± 0.6% | PSMA I&T ITM | 42154134 2026 EJNMMI Radiopharm Chem The [177Lu]Lu-PSMA I&T was produced using Elysia-Raytest's GAIA/LUNA synthesis modules. - a radiochemical yield of 97.2 ± 2.4% (without decay correction) was obtained |
| — | — | none | >97% | 50% 70%, 97% | PSMA-I&T | 41474511 2025 EJNMMI Radiopharm Chem |
| iPHASE MultiSyn iPHASE Technologies | vendor cassette | — | 99% ± 3% not corrected | 94.3 ± 0.9% 0h HPLC | PSMA-I&T Huayi | 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%. - a yield of 99% ± 3%. |
| Manual synthesis | — | — | — | >95% | PSMA-I&T ABX | 40147849 2025 J Nucl Med Radiolabeling of the DOTA compounds was done at 85°C for 25 min, using ascorbic acid buffer and no-carrier-added [177Lu]LuCl3 |
| Manual synthesis | — | — | — | — | PSMA-I&T precursor ABX | 40049746 2025 J Nucl Med All radiopharmaceuticals were radiolabeled, formulated, and quality-controlled using optimized versions of previously described methods (15). |
| Manual synthesis | — | — | — | — | PSMAI&T Center of Molecular Research, 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). |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | — | >95% | >95% | PSMA-I&T | 38378689 2024 Breast Cancer Res a cassette synthesizer type GRP 3 V (Scintomics, Germany) was used - Radiochemical purities and yields were > 95% (measured with radio-HPLC). |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | — | — | >95% | PSMAI&T Scintomics, Fürstenfeldbruck, Germany | 38067427 2023 Molecules Radiosyntheses were performed on a Modular-Lab PharmTracer (Eckert & Ziegler GmbH, Berlin, Germany) using the corresponding single-use disposable cassettes. |
| Modular-Lab EAZY Eckert & Ziegler | vendor cassette | none | 96.3 ± 2.1 | — | PSMA-I&T piCHEM, Raaba-Grambach, Austria | 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 78 to 96.3% ± 2.1% (synthesis no. 2–4) |
| Modular-Lab PharmTracer Eckert & Ziegler | vendor cassette | SPE | — | 96.9 ± 0.5% | PSMA I&T piCHEM, Raaba-Grambach, Austria | 36971890 2023 EJNMMI Radiopharm Chem [177Lu]Lu-PSMA I&T was prepared using an automated cassette based synthesis module (PharmTracer, Modular Lab, Eckert&Ziegler, Berlin, Germany) |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | none | — | — | PSMA-I&T 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 | — | — | 96.8 ± 0.9% | <95% in 24 h | PSMA-I&T ABX | 35807385 2022 Molecules For the radiolabeling of [177Lu]Lu-PSMA-I&T, a manual synthesis was used. - A typical synthesis time for the complexation reaction yielding [177Lu]Lu-PSMA I&T in 60 min with a radiochemical yield of 96.8 ± 0.9% (n = 5). |
| Manual synthesis | — | — | — | >95% | PSMA I&T 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-I&T piCHEM, Raaba-Grambach, Austria | 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% |
| Manual synthesis | — | — | >95% | >90% | PSMA-I&T Prof. Dr. Hans-Jürgen Wester, Technische Universität München | 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%. |
| miniAllinOne Trasis | — | — | — | — | PSMA-I&T | 32374450 2020 J Labelled Comp Radiopharm using the same synthesis module |
| — | — | — | 98% | — | PSMA-I&T | 40425733 2026 Nat Protoc |
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.
- Lutetium-177-PSMA-I&T as metastases directed therapy in oligometastatic hormone sensitive prostate cancer, a randomized controlled trial.2020 · BMC Cancer · Prospective, multicentre
- Comparison of Posttherapy 4- and 24-Hour [177Lu]Lu-PSMA SPECT/CT and Pretherapy PSMA PET/CT in Assessment of Disease in Men with Metastatic Castration-Resistant Prostate Cancer.2024 · J Nucl Med · Prospective
- A standardised attenuated dosing of 177 lutetium-prostate-specific membrane antigen therapy for patients with metastatic castration-resistant prostate carcinoma and preexisting renal impairment.2026 · Nucl Med Commun · Retrospective
- Prognostic 18F-flotufolastat PET parameters for outcome assessment of 177Lu-labeled PSMA-targeted radioligand therapy in metastatic castration-resistant prostate cancer.2025 · Eur J Nucl Med Mol Imaging · Retrospective
- Efficacy and safety of rechallenge with [177Lu]Lu-PSMA-I&T radioligand therapy in metastatic castration resistant prostate cancer.2024 · Eur J Nucl Med Mol Imaging · Retrospective
- Outcomes and prognostic predictors of Lu-177 PSMA radioligand therapy in metastatic castration-resistant prostate cancer (Asian Population Study).2024 · Asia Pac J Clin Oncol · Retrospective
- Baseline clinical characteristics predict overall survival in patients undergoing radioligand therapy with [177Lu]Lu-PSMA I&T during long-term follow-up.2022 · Eur J Nucl Med Mol Imaging · Retrospective
- Modeling and Predicting Tumor Response in Radioligand Therapy.2019 · J Nucl Med · Retrospective
- [177Lu]Lu-PSMA SPECT/CT for early response assessment using quantitative RECIP 1.0.2026 · Eur J Nucl Med Mol Imaging · Clinical study
- Radioligand treatment with [177Lu]Lu-PSMA I&T in elderly Patients - Safety, efficacy, and prognostic factors for survival.2026 · Eur J Nucl Med Mol Imaging · Clinical study
Show all 18 clinical studies
- Rapid Tumor Washout of 177 Lu-PSMA Radioligand in Renal Cell Carcinoma.2023 · Clin Nucl Med · Clinical study
- Costs of radium-223 and the pharmacy preparation 177Lu-PSMA-I&T for metastatic castration-resistant prostate cancer in Dutch hospitals.2023 · J Med Econ · Clinical study
- Biodistribution and dosimetry for combined [177Lu]Lu-PSMA-I&T/[225Ac]Ac-PSMA-I&T therapy using multi-isotope quantitative SPECT imaging.2023 · Eur J Nucl Med Mol Imaging · Clinical study
- Factors affecting overall survival and progression-free survival in patients with metastatic castration resistant prostate cancer received 177Lu PSMA I&T therapy.2020 · Hell J Nucl Med · Clinical study
- The use of molecular volumetric parameters for the evaluation of Lu-177 PSMA I&T therapy response and survival.2019 · Ann Nucl Med · Clinical study
- The Effect of Total Tumor Volume on the Biologically Effective Dose to Tumor and Kidneys for 177Lu-Labeled PSMA Peptides.2018 · J Nucl Med · Clinical study
- 68Ga- and 177Lu-Labeled PSMA I&T: Optimization of a PSMA-Targeted Theranostic Concept and First Proof-of-Concept Human Studies.2015 · J Nucl Med · Clinical study
- Rapid Lymphatic Clearance After Subcutaneous Extravasation of 177 Lu-PSMA-I&T Radioligand Therapy.2026 · Clin Nucl Med · Case report
Precursor
- Common precursor
- PSMA-I&T PMID 37233924 (DOI 10.1186/s41181-023-00196-1)
- Suppliers seen in the literature
- piCHEM (Raaba-Grambach, Austria)
- Cited suppliers in indexed syntheses
- ABX, Center of Molecular Research, Huayi, ITM, Prof. Dr. Hans-Jürgen Wester, Scintomics, Fürstenfeldbruck, Technical University Munich, piCHEM
- Typical final purification
- none (direct sterile filtration, no chromatographic step)
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Get in touchQuality 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.
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
Setting up quality control?We can help you scope the equipment needed to release [177Lu]Lu-PSMA-I&T.
Get in touchNotes
Added from reverse module search (stage 6); 10 article(s) with Lu-177. | Stage 30 (2026-09-18): Stage was 'Investigational / clinical (academic use)'; normalised to 'Clinical research', original wording kept here.