Tracers / [68Ga]Ga-PSMA-617
[68Ga]Ga-PSMA-617
Also written as 68Ga-PSMA-617; [68Ga]Ga-PSMA-617; [Ga-68]Ga-PSMA-617; PSMA-617
- Radionuclide
- Ga-68 t½ 67.71 min
- Modality
- PET
- Production route
- —
- Stage
- Phase II clinical trial
- Syntheses indexed
- 30
What it is
- Compound class
- PSMA-targeted urea-based small-molecule inhibitor (PSMA-617)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA) inhibitor PMID 38424422
- Clinical application
- PET/CT imaging for staging, restaging and detection of biochemical relapse in prostate cancer PMID 35056066
- Theranostic pair
- —
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 |
|---|---|---|---|---|---|---|
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 48 % at EOS (decay corr. 79 %) yes | 96 % | 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. — 68Ga-PSMA-617 was obtained with a yield of 48 % at EOS (decay corr. 79 %) |
| GAIA Elysia-Raytest | vendor cassette | SPE | <20% with 20 µg; not explicitly stated with 40 µg | 97.4% ± 1.1% (TLC); 93.6% ± 0.9% (HPLC) | PSMA-617 MedChemExpress | 38424422 2024 Curr Radiopharm A GAIA® synthesis module and a GALLIAD® generator were used. — Initial experiments with the automated method described above involving only 20 µg of PSMA-617 were conducted, and were associated with low RCY (<20%). |
| Manual synthesis | custom manifold | SPE | >95 yes | >99% | PSMA-617 | 38512591 2024 EJNMMI Radiopharm Chem the possibility to perform an organic-solvent-free purification represents a major simplification. — SPE work-up afforded a significantly higher recovery of > 95% |
| — | custom manifold | none | — | ≥96% | PSMA-617 Jenguro Ltd., Moscow, Russia | 42653427 2026 Int J Mol Sci |
| — | — | — | — | >95% | — | 42304982 2026 Ann Med |
| iQS-TS ITG (Isotope Technologies Garching) | — | SPE | 80.1 ± 6.55% | >99% | PSMA-617 Tianjin Hengrui Pharmaceutical Co., Ltd. | 42222801 2026 ACS Omega iQS-theranostics synthesizer (iQS-TS, ITG GmbH, Germany) for automated radiolabeling — yield rates of 77.5 ± 7.23% and 80.1 ± 6.55%, respectively |
| Manual synthesis | — | — | >94% | >94% | PSMA-617 | 41510166 2026 Theranostics Radiolabeling with [177Lu]Lu3+ was completed by the addition of precursor peptides PS1 - PS11 — radiochemical yields of greater than 94% for the 68Ga-labeled and greater than 96% for the 177Lu-labeled compounds |
| Manual synthesis | — | — | — | — | PSMA-617 | 41407974 2026 Eur J Nucl Med Mol Imaging 1 mL of 68GaCl3 (187 MBq) was added to 90 µL NaOAc (1.5 M) and reacted with 10 µg AP-01 or PSMA-617 at 100 °C for 10 min to acquire 68Ga-AP-01 and 68Ga-PSMA-617, respectively |
| Manual synthesis | — | — | over 90% | above 95% | PSMA-617 | 39563828 2024 ACS Med Chem Lett [68Ga]Ga, Hepes buffer (0.25 M), pH = 4.0, 95 °C, 30 min. — radiochemical yield was over 90% |
| — | — | — | — | — | — | 39327017 2024 J Nucl Med |
| GAIA Elysia-Raytest | vendor cassette | SPE | — | mean RCP by TLC = 97.4% ± 1.1%; mean RCP by HPLC = 93.6% ± 0.9% | PSMA-617 MedChemExpress | 38424422 2024 Curr Radiopharm For [68Ga]Ga-PSMA-617 preparation, the automated sequence described above was used unchanged. |
| — | — | — | — | — | — | 38398552 2024 Molecules |
| — | — | — | — | — | — | 36215569 2023 J Nucl Med |
| Manual synthesis | — | none | >95% | >98% | PSMA-617 | 36015144 2022 Pharmaceuticals (Basel) The radiolabeling was performed by incubating PSMA-617 (20 nmol) with 1–1.2 GBq of 68GaCl3 (adjusted to pH 3.8 with 1 M ammonium acetate buffer, pH 4.5) at 95 °C for 12 min. — This tracer [9] is routinely prepared in our center with a radiochemical yield higher than 95%, as determined by UPLC (Figure S9). |
| — | — | — | — | — | — | 35984529 2022 EJNMMI Res |
| — | — | — | — | >97% | PSMA-617 | 35056066 2021 Pharmaceuticals (Basel) |
| Scintomics GRP / GRP-3V Scintomics | vendor cassette | SPE | 48 % (decay corr. 79 %) yes | 96 % | 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. — 68Ga-PSMA-617 was obtained with a yield of 48 % at EOS (decay corr. 79 %) |
| — | — | — | — | — | — | 42624106 2026 Cell Stem Cell |
| — | — | — | — | — | — | 42314598 2026 Bioorg Chem |
| — | — | — | — | — | — | 42308923 2026 Biomed Pharmacother |
| — | — | — | — | >99% | PSMA-617 | 42300211 2026 Org Biomol Chem Purified PSMA-617 was radiolabelled with 68Ga in >99% radiochemical purity, confirming chemical integrity. |
| — | — | — | — | — | PSMA-617 | 42262712 2026 Ann Nucl Med |
| — | — | — | — | — | — | 42101325 2026 Mol Pharm |
| — | — | — | — | — | — | 41698561 2026 Pharmacol Res |
| — | — | — | — | — | — | 41656418 2026 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 41611483 2026 J Nucl Med |
| — | — | — | — | — | PSMA-617 | 41521448 2026 Adv Healthc Mater |
| — | — | — | — | — | — | 40518457 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 39745526 2025 Eur J Nucl Med Mol Imaging |
| — | — | — | — | — | — | 36811661 2023 Eur J Nucl Med Mol Imaging |
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Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- —
- USP monograph
- —
How this set was arrived at. base set per Ph. Eur. general monograph 0125 (rule); radiometal tracer -> metal impurities (rule); Ga-68, generator-produced per synthesis data (PMID 27090254) -> Ge-68 breakthrough; 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 [68Ga]Ga-PSMA-617.
Get in touchNotes
Stage 8: 2 corpus articles with Ga-68 PSMA-617 (PMID 40638023, 40441170) were collapsed onto the In-111 anchor. Added. Compound class inferred from precursor name (not stated outright) -- PMID 38424422: 'PSMA-617'. Stage set/updated at stage 23 from PMID 36215569: 'Comparison of 68Ga-PSMA-617 PET/CT and 68Ga-RM2 PET/CT in Patients with Localized Prostate Cancer Who Are Candidates for Radical Prostatectomy: A Prospective, Single-Arm, Single-Center, Phase II Study.'.