Tracers / [68Ga]Ga-PSMA-11

[68Ga]Ga-PSMA-11

Also written as [68Ga]Ga-PSMA-11; [68Ga]Ga-PSMA-HBED-CC; [68Ga]Ga-PSMA11; [68Ga]PSMA-11; [68Ga]PSMA-HBED-CC; [Ga-68]Ga-PSMA-11; [Ga-68]Ga-PSMA-HBED-CC
Radionuclide
Ga-68 t½ 67.7 min
Modality
PET
Production route
Generator / Cyclotron liquid target
Stage
Approved
Syntheses indexed
108

What it is

Compound class
Small molecule (urea-based)
Target / mechanism
Prostate-specific membrane antigen (PSMA / glutamate carboxypeptidase II) PMID 28283702 / DOI 10.1007/s00259-017-3670-z
Clinical application
Prostate cancer staging and biochemical recurrence PMID 28283702 / DOI 10.1007/s00259-017-3670-z
Theranostic pair
<a href="/tracers/lu177-psma617/">lu177-psma617</a>

Regulatory status

FDA
Yes — 2020; gallium Ga 68 gozetotide (NDA 212642 UCLA / NDA 212643 UCSF); commercial kits Illuccix (Telix, 2021), Locametz (Novartis, 2022), Gozellix (Telix, 2025) Drugs@FDA, NDA 212642 & 212643, approved 2020-12-01 (kits NDA 214032 / 215841 / 219592) — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=gozetotide
EMA (centralised)
Yes — 2022; Locametz (gozetotide); Novartis Europharm Limited; EMEA/H/C/005488 EMA medicines register, EPAR Locametz, marketing authorisation issued 2022-12-09 — https://www.ema.europa.eu/en/medicines/human/EPAR/locametz
Other approvals
Brand names
Illuccix; Locametz; Gozellix (US, FDA); Locametz (EU, EMA)

Clinical use

Typical injected activity
~150-200 MBq (e.g. 182 +/- 47 MBq); ~1.8-2.2 MBq/kg per EANM/SNMMI guideline PMID 38761312 / DOI 10.1007/s12149-024-01939-z; PMID 28283702 / DOI 10.1007/s00259-017-3670-z
Uptake time
50-100 min post-injection (typically ~60 min) PMID 28283702 / DOI 10.1007/s00259-017-3670-z

Reported in the literature. Not a dosing recommendation.

Published syntheses

ModuleCassettePurificationYield %RCP %Precursor / supplierSource
Advion NanoTek
Advion
custom manifoldPSMA-HBED-CC
ABX
27090254
2016 EJNMMI Res
using an Advion NanoTek LF system containing a flow-through microreactor
GAIA V2
Elysia-Raytest
vendor cassettenone89.55 ± 5.49>99%PSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
Generators elution was performed using the GAIA® V2 module (Elysia-Raytest, Germany) controlled via the dedicated software (GAIA Control, Elysia-Raytest, Germany). — after process optimization, routine RCY improved to 89.55 ± 5.49%
Manual synthesisfixed tubingnone88.41 ± 4.7299.59% ± 0.35% by TLC and 98.75% ± 0.31% by HPLCPSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
68Ga eluates were used without elution processing, after elution of either one or two GalliAd® generators. — RCY (%) (mean value) 76.80 ± 5.4488.41 ± 4.72
GAIA V2
Elysia-Raytest
vendor cassettenone70.46 ± 2.6499.93 ± 0.06% by HPLC and 99.74 ± 0.27% by iTLCPSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
Two GalliaPharm® generators were eluted using an automated fractionation method. 1.7 mL of 0.1 M HCl from the more recently installed generator and 0.7 mL from the older generator were collected, for a total of 2.4 mL per aliquot. — The RCY for the three validation batches was 70.46 ± 2.64%, and 66.31 ± 6.78% in routine production
Manual synthesisfixed tubingnone78.79 ± 4.6095.84% ± 4.94% by TLC and 93.72% ± 4.39% by HPLCPSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
Two GalliAd® generators were manually eluted in sequence (1.1 mL of 0.1 M HCl each) and combined directly in the aliquot vial. — RCY (%) (mean value) 70.46 ± 2.6478.79 ± 4.60
Scintomics GRP / GRP-3V
Scintomics
vendor cassettenone91-102%
yes
98.0-99.6%Locametz® kit (gozetotide, PSMA-11)
Novartis
38632189
2024 EJNMMI Radiopharm Chem
a Scintomics® GRP 3V module (Scintomics® GmbH, Fürstenfeldbruck, Germany) — Radiolabelling with one and two generator(s) resulted in a radiochemical yield of 91–102% and 96–101% after preparation, respectively.
Scintomics GRP / GRP-3V
Scintomics
vendor cassettenone96-101%
yes
98.4-99.3%Locametz® kit (gozetotide, PSMA-11)
Novartis
38632189
2024 EJNMMI Radiopharm Chem
a Scintomics® GRP 3V module (Scintomics® GmbH, Fürstenfeldbruck, Germany) — Radiolabelling with one and two generator(s) resulted in a radiochemical yield of 91–102% and 96–101% after preparation, respectively.
GAIA
Elysia-Raytest
vendor cassetteSPE68.3% ± 2.1%97.72% ± 0.04% (TLC); 91.24% to 94.81% (HPLC)PSMA-11
ABX
38424422
2024 Curr Radiopharm
A GAIA® synthesis module and a GALLIAD® generator were used. — These three validation batches were produced with a mean RCY of 68.3% ± 2.1%.
In-house / custom builtcustom manifoldSPE83 ± 11%
yes
>99%PSMA-11 precursor
ABX
39407503
2024 Molecules
Synthesis of [68Ga]Ga-PSMA-11 using concentrated Ga-68 was conducted on a Teflon-coated silicon chip patterned with a circle hydrophilic reaction site, operated on a temperature-controlled heating platform — the final product was obtained with a high radiochemical yield (RCY) of 83 ± 11% (n = 3)
miniAllinOne
Trasis
vendor cassetteSPE45.8 ± 29.471.8%PSMA-11
Iason GmbH
38004410
2023 Pharmaceuticals (Basel)
radiosynthesis was performed on MiniAIO® synthesis module (Trasis®, Ans, Belgium) — The mean labeling yields for double elution with prepurification were 45.8 ± 29.4 (mean ± standard deviation)
miniAllinOne
Trasis
vendor cassetteSPE97.5 ± 1.9PSMA-11
Iason GmbH
38004410
2023 Pharmaceuticals (Basel)
radiosynthesis was performed on MiniAIO® synthesis module (Trasis®, Ans, Belgium) — The mean labeling yields for the fractionated double elution were 97.5 ± 1.9 (mean ± standard deviation)
GAIA V2
Elysia-Raytest
vendor cassetteSPE81 ± 3%
no
>95%PSMA-11
Advanced Biochemical Compounds, ABX, Germany
35337140
2022 Pharmaceuticals (Basel)
Synthesis was performed on a fully automated radiosynthesis cassette module (GAIA V2™, Elysia-Raytest, Straubenhard, Germany) — a high (81 ± 3% non-decay corrected) and highly reproducible RCY
iQS-TSSPE86.82% ± 2.57%more than 99%PSMA-1135177423
2022 J Nucl Med
An iQS-TS automated module was used for all radiolabeling steps — yield rates of 88.07% ± 1.26% and 86.82% ± 2.57%, respectively
Modular-Lab PharmTracer
Eckert & Ziegler
vendor cassetteSPE>85%
no
99.06 ± 0.10%Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11)
ABX
33918987
2021 Pharmaceuticals (Basel)
an automated Modular-Lab PharmTracer synthesis module (Eckert and Ziegler—Berlin, Germany) for routine production — Radiolabeling yields of >85% were obtained.
iPHASE MultiSyn
iPHASE Technologies
vendor cassetteSPE76 ± 3
yes
99.9 ± 0.2PSMA-11
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.
GAIA V2
Elysia-Raytest
vendor cassette91% vs 43%
no
PSMA-11
Advanced Biochemical Compounds, ABX, Germany
33761040
2021 EJNMMI Radiopharm Chem
loaded in an automated radiosynthesis module (GAIA V2™, Elysia-Raytest, Germany), by using disposable reagents assembled in a disposable sterile cassette. — a decrease in the percentage of radiolabeling yield non-decay corrected (n.d.c.) at end of synthesis (EOS) (i.e., 91% vs 43%)
34529005
2021 JAMA Oncol
FASTlab Developer
GE HealthCare
vendor cassetteSPE
yes
99.4PSMA-11 precursor33180205
2020 EJNMMI Radiopharm Chem
GE FASTlab Developer platform
Scintomics GRP / GRP-3V
Scintomics
vendor cassetteSPEPSMA-11
ABX
32939194
2020 World J Nucl Med
the Scintomics GRP module was used for automated synthesis
Scintomics GRP / GRP-3V
Scintomics
SPEPSMA-11
ABX
32410136
2020 EJNMMI Radiopharm Chem
The syntheses were performed using a GRP® synthesis module from Scintomics (Fürstenfeldbruck, Germany) with the cationic concentration protocol provided by Scintomics.
ITG labeling module
ITG (Isotope Technologies Garching)
SPEmore than 95%99.6 ± 0.1%HBED-CC-Lys-CO-Glu (Glu-urea-Lys(Ahx)-HBED-CC)29853810
2018 Contrast Media Mol Imaging
68Ga-PSMA-11 was semiautomatically synthesized using the labeling module (iTG) as shown in Supplemental Figure 1. — The radiochemical yield of 68Ga-PSMA-11 from the synthesis module was more than 95%.
40638023
2025 Ann Nucl Med
31855410
2020 Bioconjug Chem
40580320
2025 Eur J Nucl Med Mol Imaging
iQS-TS
ITG (Isotope Technologies Garching)
vendor cassetteSPE63.499.3PSMA-1134658552
2021 Indian J Nucl Med
Hot cell to house 68Ga iQS-TS Synthesis module, ITG, Germany — 68Ga PSMA-11 13 63.4±2.2 4-6 99.3±0.2
PSMA-HBED-CC38424612
2024 Cancer Imaging
GAIA V2
Elysia-Raytest
vendor cassettenone89.55 ± 5.49%> 99%PSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
Generators elution was performed using the GAIA® V2 module (Elysia-Raytest, Germany) — after process optimization, routine RCY improved to 89.55 ± 5.49%
Kit-based preparationvendor cassettenone80.07 ± 1.71%99.99% ± 0.01%PSMA-11
Novartis
42251618
2026 EJNMMI Radiopharm Chem
lyophilized PSMA-11 kits (Locametz®, Novartis, France) were reconstituted with 1 mL of water for injection — RCY (%) (mean value) 83.53 ± 6.16 80.07 ± 1.71
41886137
2026 Curr Treat Options Oncol
Scintomics GRP / GRP-3Vvendor cassetteSPE62>99% for 68Ga-PSMAPSMA-HBED-CC41824275
2026 EJNMMI Radiopharm Chem
an automated synthesis module (Scintomics GRP®, Fürstenfeldbruck, Germany) — assuming a reference radiolabelling yield of 62%
41771032
2026 Clin Nucl Med
41489652
2026 Eur J Nucl Med Mol Imaging
Modular-Lab Standard
Eckert & Ziegler
94.31±6.18>95%PSMA-1141370506
2025 Einstein (Sao Paulo)
the standardization of the automated synthesis process using a Modular-Lab Standard module (Eckert & Ziegler) — Labeling Yield (%)89.03±3.7894.31±6.18
Manual synthesisnone>97%PSMA-11 trifluoroacetate salt (precursor A) / PSMA-11/Mannitol (precursor B)
ABX
40941986
2025 Molecules
PSMA-11 precursor and 5 mg of ascorbic acid dissolved in 1 mL of acetate buffer were added to a vial containing about 5 mL of gallium-68 chloride in 0.1 M hydrochloric acid. The vial was placed in a heating block preheated to 95 °C and incubated for 5 min. — The labeling of [68Ga]Ga-PSMA-11 was performed using activities that yielded final product activities in the range of 1090–3095 MBq, with most values exceeding 2000 MBq.
Kit-based preparation
POLATOM
vendor cassettenone>97%PSMA-11 kit for radiolabeling
POLATOM
40941986
2025 Molecules
The labeling procedure of the precursor C was performed according to the standard kit manufacturer’s instruction. — The labeling of [68Ga]Ga-PSMA-11 was performed using activities that yielded final product activities in the range of 1090–3095 MBq, with most values exceeding 2000 MBq.
40638023
2025 Ann Nucl Med
40448740
2025 Curr Urol Rep
40414994
2025 Eur J Nucl Med Mol Imaging
40304782
2025 Eur J Nucl Med Mol Imaging
40213671
2025 Theranostics
Manual synthesismore than 95%PSMA-11
ABX
40147849
2025 J Nucl Med
68Ga radiolabeling of PSMA-11 was done by eluting a 68Ge/68Ga generator (ITM Medical Isotopes GmbH) with 4 mL of 0.05 M hydrochloric acid into a 1-mL sodium acetate buffer containing 35 µg of PSMA-11.
Kit-based preparationHPLC>97%PSMA-11
ABX
40135799
2025 J Med Chem
PSMA-11 (4–8 μg ≙ 4.2–8.4 nmol; ABX advanced biochemical compounds GmbH, Radeberg, Germany) was labeled with 68GaCl3 (150 to 250 MBq) in 400 μL ammonium acetate (2 M) and HCl at pH 4.5. — The radiochemical yield for [68Ga]Ga-PSMA-11 was >97%
39878896
2025 Eur J Nucl Med Mol Imaging
39794510
2025 Eur J Nucl Med Mol Imaging
39743616
2025 Eur J Nucl Med Mol Imaging
Kit-based preparation
Novartis
vendor cassette95.03%
no
98.41 ± 0.47%PSMA-11
Novartis
39692998
2024 EJNMMI Radiopharm Chem
Cold kit labeling is expected to facilitate global access to 68Ga-labeled radiopharmaceuticals including [68Ga]Ga-PSMA-11 — Using the Locametz kits, the overall production success rate was 95.03% (172/181).
Kit-based preparation
Telix Pharmaceuticals
vendor cassette99.22%
no
97.81 ± 0.71%PSMA-11
Telix Pharmaceuticals
39692998
2024 EJNMMI Radiopharm Chem
Cold kit labeling is expected to facilitate global access to 68Ga-labeled radiopharmaceuticals including [68Ga]Ga-PSMA-11 — Using Illuccix kits (n = 256), the overall production success rate was 99.22% (254/256).
PSMA-11 (Glu-CO-Lys-Ahx-HBED-CC)39661209
2024 EJNMMI Radiopharm Chem
FASTlab 2
GE HealthCare
custom manifoldnone98.83 ± 0.19HBED-CC-PSMA-11
ABX
39598846
2024 Molecules
Automated labeling of the precursor was accomplished using a FASTLab 2 synthesizer.
In-house / custom builtcustom manifoldSPE83 ± 11%
yes
>99%PSMA-11 precursor
ABX
39407503
2024 Molecules
microdroplet synthesis of [68Ga]Ga-PSMA-11 — the final product was obtained with a high radiochemical yield (RCY) of 83 ± 11% (n = 3)
39268679
2024 Cancer Biother Radiopharm
39207485
2024 Eur J Nucl Med Mol Imaging
39136560
2024 Radiology
39060832
2024 Ann Nucl Med
38948055
2024 Theranostics
98%99%HBED-CC38855174
2024 Theranostics
38760451
2024 Sci Rep
38724653
2024 Eur J Nucl Med Mol Imaging
HBED-CC38577331
2024 Front Oncol
PSMA-HBED-CC38424612
2024 Cancer Imaging
GAIA
Elysia-Raytest
vendor cassetteSPE68.3% ± 2.1%97.72% ± 0.04%PSMA-11
ABX
38424422
2024 Curr Radiopharm
A GAIA® synthesis module and a GALLIAD® generator were used. — These three validation batches were produced with a mean RCY of 68.3% ± 2.1%.
PSMA-11
ABX
37889298
2024 Eur J Nucl Med Mol Imaging
36302657
2023 J Nucl Med
Scintomics GRP / GRP-3V
Scintomics
vendor cassetteSPEPSMA
ABX
35889351
2022 Molecules
the automated synthesis module Scintomics GRPTM (Scintomics GmbH, Fürstenfeldbruck, Germany)
miniAllinOne
Trasis
vendor cassettenone80.98 ± 0.05% (L); 71.48 ± 0.04% (H)
no
99.91% (L); 99.96% (H)PSMA-11
ABX
35744985
2022 Molecules
Radiosyntheses were performed using an All In One mini automated synthesizer (Trasis, Ans, Belgium) and cassettes without pre-purification after generator elution. — The average value of RCY for L activity, not corrected for decay, was 80.98 ± 0.05%, decreasing to 71.48 ± 0.04% for H activity.
35406542
2022 Cancers (Basel)
>97%PSMA-1135056066
2021 Pharmaceuticals (Basel)
Manual synthesisPSMA-11
ABX
34370181
2022 Mol Imaging Biol
[68Ga]Ga-PSMA-11 and [18F]F-JK-PSMA-7 were labeled according to standard protocols, which have been published elsewhere [18].
PSMA-1133778927
2021 Curr Oncol Rep
33674398
2021 J Nucl Med
33465252
2021 Prostate
31940969
2020 Pharmaceuticals (Basel)
Manual synthesis31107537
2019 Mutagenesis
[68Ga]Ga-PSMA-11 was radiosynthesised as previously described (13).
Advion NanoTek
Advion
custom manifoldPSMA-HBED-CC
ABX
27090254
2016 EJNMMI Res
Ga-68-radiolabeling of PSMA-HBED-CC (ABX, GMP grade) was performed using an Advion NanoTek LF system containing a flow-through microreactor
2841 ± 584 MBq
yes
>99%42496850
2026 Ann Nucl Med
synthesized using an automated module — a decay-corrected radiochemical yield of 2841 ± 584 MBq
40132471
2025 Eur J Radiol
1.52 GBq>95 %[68Ga]GaCl338447298
2024 Nucl Med Biol
used to label 1 NetSpot and 2 Illuccix kits simultaneously — [68Ga]GaCl3 was added to 2.5 mL of buffer which gave 1.52 GBq of [68Ga]Ga-PSMA-11
gallium (68 Ga) chloride35869898
2022 J Labelled Comp Radiopharm
The first method for the [68 Ga]Ga-PSMA11 radiopharmaceutical was performed with the automated synthesis module, which is widely used in clinical practice.
gallium (68 Ga) chloride35869898
2022 J Labelled Comp Radiopharm
Radiolabeling success, suitability of quality control parameters, and in vitro stability of [68 Ga]Ga-PSMA11 radiopharmaceutical performed with ANMI kit were examined.
gallium (68 Ga) chloride35869898
2022 J Labelled Comp Radiopharm
Direct cold labeling of PSMA11 ligand with sodium bicarbonate buffer was examined.
51.2%68Zn34763197
2022 Nucl Med Biol
using a single FASTlab time-list — a radiochemical yield of 51.2% was produced in 63 min
>99%68Zn34763197
2022 Nucl Med Biol
by kit labeling (N = 1)
PSMA-1132865290
2020 J Labelled Comp Radiopharm
Cold-kits or automated synthesis are viable options for standardized methods
PSMA-1132865290
2020 J Labelled Comp Radiopharm
a manual kit-based method with a module-based automated synthesis approach
PSMA-HBED-CC32374450
2020 J Labelled Comp Radiopharm
using the Trasis miniAllinOne radiosynthesizer
31601704
2020 J Nucl Med
synthesized using ... synthesis modules
31601704
2020 J Nucl Med
a sterile cold kit was recently introduced
SPE>99%PSMA-1132796487
2020 Nucl Med Commun
The radiosynthesis of [Ga]Ga PSMA-11 was performed using a Trasis MiniAio synthesizer
70%>99%32632739
2020 Mol Imaging Biol
a microfluidic chip was assembled in polydimethylsiloxane (PDMS), combining all components of tracer production in an integrated, compact, and easily utilized platform — with an average radiochemical yield of 70 %
84.2 ± 6.3%>95%PSMA-HBED-CC32796488
2020 Nucl Med Commun
previously used Modular-Lab module — Automated module-involved synthesis of [Ga]Ga-PSMA-HBED- CC resulted in a radiochemical yield of 84.2 ± 6.3%
>98%>95%PSMA-HBED-CC32796488
2020 Nucl Med Commun
For labeling with the lyophilized cold kit isoPROtrace-11, 2.5 ml 0.1 M HCl of the middle Ga-68 elution fraction were added to the kit — The room temperature cold kit gave a radiochemical yield of >98%
77% ± 2%exceeding 97%PSMA-1130672007
2019 J Labelled Comp Radiopharm
Automated production of [68 Ga]Ga-DOTANOC and [68 Ga]Ga-PSMA-11 using a TRACERlab FXFN synthesis module. — Activity yields were 77% ± 2% for [68 Ga]Ga-PSMA-11
84 ± 6%>98%28950199
2017 Appl Radiat Isot
>95%27907840
2017 Nucl Med Biol
without use of any synthesis module
SPE93.19%±3.76%>99%PSMA-11 ligand27231953
2016 Nucl Med Biol
using (68)Ge/(68)Ga generator and a manual synthesis module, both supplied by Isotope Technologies Garching (ITG), Germany — The radiochemical yields obtained were consistently high, 93.19%±3.76%
SPE49 ± 1.2 %
yes
≥98 %PSMA-HBED (Glu-NH-CO-NH-Lys(Ahx)-HBED-CC)25869080
2015 Mol Imaging Biol
41006727
2025 Med Oncol
PSMA-1131845408
2020 J Labelled Comp Radiopharm
utilizing a cassette module (GAIA; Elysia-Raytest; Germany) with a manual setup
PSMA-1131845408
2020 J Labelled Comp Radiopharm
manual setup for routine clinical production
31655351
2020 Appl Radiat Isot
42560334
2026 Radiat Prot Dosimetry
42437859
2026 Discov Oncol
42314598
2026 Bioorg Chem
41986500
2026 Nat Cancer
41698561
2026 Pharmacol Res
33883490
2021 Clin Nucl Med
32149812
2020 Clin Nucl Med
31977467
2020 Clin Nucl Med

Precursor

Common precursor
PSMA-11 (HBED-CC conjugate) PMID 32080309 / DOI 10.1038/s41598-020-60099-y
Suppliers seen in the literature
PSMA-11 (Glu-NH-CO-NH-Lys(Ahx)-HBED-CC) precursor from ABX (Radeberg, Germany); also supplied as sterile cold kits (ANMI SA, Liege, Belgium; and the licensed Locametz / Illuccix kits)
Cited suppliers in indexed syntheses
ABX, Advanced Biochemical Compounds, Iason GmbH, Novartis, POLATOM, Telix Pharmaceuticals
Typical final purification
SPE

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Quality control Pharmacopoeial monograph

Ph. Eur. monograph
3044
USP monograph
not verified — the USP-NF monograph index is subscription-only and no public confirmation was found
AppearancepHRCP HPLCRCP TLCHPLC UVRadionuclidic (HPGe)Half-lifeActivityEndotoxins (LAL)SterilityFilter integrityMolar activityMetal impuritiesGe-68 breakthrough
How this set was arrived at. Base set per Ph. Eur. 0125 + monograph 3044. Ge-68 breakthrough + metal impurities: generator-produced Ga-68 only. RECOMMEND ADD: molar activity / peptide content — PSMA-11 is a saturable-target receptor ligand and monograph 3044 controls peptide content.

Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived

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Notes

Produced both from generator and from liquid- and solid-target cyclotron Ga-68.