Drugs / 68Ga-PSMA-11
68Ga-PSMA-11
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ILLUCCIX | — | 2023-03-15 | fda.gov ↗ |
| Approved | US (FDA) | GALLIUM GA 68 GOZETOTIDE | — | 2020-12-01 | fda.gov ↗ |
Trials 77 · started per year
today
US approved 2020
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 013 trials | ||||||
| Phase 0 | NCT07674771 | Jul 2026 → Jun 2029 expected | castration-resistant prostate carcinoma | University of Texas Southwestern Medical Center | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT06462508 | Apr 2024 → Jun 2025 | prostate cancer | Anhui Provincial Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT06437496 | Apr → Jul 2024 | prostate cancer | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT05955677 | Jul 2023 → Jul 2024 | prostate cancer | Anhui Provincial Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT05558956 | Nov 2022 → Dec 2023 | castration-resistant prostate carcinoma | BAMF Health | Unknown | No outcome recorded |
| Phase 0 | NCT04976257 | Oct 2021 → Mar 2023 | prostate adenocarcinoma | Ryan Kohlbrenner, MD | Completed | No outcome recorded |
| Phase 0 | NCT04831541 | Oct 2020 → Dec 2024 | prostate cancer | First Affiliated Hospital of Fujian Medical University | Unknown | No outcome recorded |
| Phase 0 | NCT04801264 | Sep 2020 → Sep 2022 | adenoid cystic carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04310540 | Jun 2020 → Nov 2023 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT03982407 | Jun 2019 → May 2021 | hepatocellular carcinoma | Ajit H. Goenka, MD | Completed | No outcome recorded |
| Phase 0 | NCT04282824 | Jun 2019 → May 2020 | prostate carcinoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 0 | NCT03768349 | Jan 2019 → Jul 2021 | prostate cancer | Mayo Clinic | Completed | No outcome recorded |
| Phase 0 | NCT02952469 | Jul 2016 → Apr 2022 | prostate cancer | University of Iowa | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06379217 | Jul 2024 → Aug 2026 overdue | prostate neuroendocrine neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04750473 | Jul 2021 → Mar 2023 | female breast carcinoma, invasive lobular breast carcinoma | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT04279561 | Apr 2020 → Sep 2022 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Jonsson Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT04216134 | Dec 2019 → Dec 2022 | prostate carcinoma | City of Hope Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03822871 | Apr 2019 → Oct 2022 | prostate cancer | Cancer Targeted Technology | Completed | No outcome recorded |
| Phase 1 | NCT03183544 | Jan 2019 → Feb 2020 | prostate neoplasm | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT07117760 | Apr 2025 → Dec 2027 expected | prostate cancer | First Affiliated Hospital of Fujian Medical University | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05627778 | Nov 2021 → Dec 2022 | metastatic prostate carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT04614363 | Oct 2020 → Feb 2022 | prostate cancer | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT03949517 | Apr 2019 → Mar 2022 | prostate cancer | Andrei Iagaru | Completed | No outcome recorded |
| Phase 1/2 | NCT03545165 | Apr 2018 → Jul 2020 | prostate cancer | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 1/2 | NCT03362359 | Oct 2017 → Jul 2020 | metastatic malignant neoplasm in the lymph nodes, metastatic prostate carcinoma | German Cancer Research Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02488070 | Jun → Aug 2015 | prostate carcinoma | Stanford University | Completed | No outcome recorded |
| Phase 225 trials | ||||||
| Phase 2 | NCT06444412 | Jan 2026 → Jul 2028 expected | grade III glioma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06560905 | Mar → Dec 2025 overdue | melanoma | Royal Marsden NHS Foundation Trust | Recruiting | No outcome recorded |
| Phase 2 | NCT06521775 | Aug 2024 → Aug 2025 | adenoid cystic carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT04243941 | Nov 2022 → Feb 2024 | prostate cancer | UNC Lineberger Comprehensive Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05034562 | Sep 2022 | metastatic prostate carcinoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05176223 | Jan 2022 → Dec 2025 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05214820 | Jan 2022 → Dec 2026 expected | digestive system cancer | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04716725 | Sep 2021 → Sep 2023 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Thomas Hope | Terminated | No outcome recorded |
| Phase 2 | NCT04777071 | May 2021 → Jul 2025 overdue | prostate adenocarcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04483414 | Mar 2021 → Apr 2023 | metastatic carcinoma in the bone, metastatic prostate carcinoma | Dana Mathews | Withdrawn | No outcome recorded |
| Phase 2 | NCT04762888 | Feb 2021 → Jun 2025 | hepatocellular carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT06484361 | Sep 2020 → Sep 2025 | prostate cancer | IRCCS San Raffaele | Unknown | No outcome recorded |
| Phase 2 | NCT05806853 | Jun 2020 → Oct 2022 | prostate cancer | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 2 | NCT04264208 | Feb 2020 → Nov 2022 | prostate cancer | Andrei Iagaru | Terminated | No outcome recorded |
| Phase 2 | NCT04179968 | Jan 2020 → Sep 2021 | metastatic prostate carcinoma | Dana Mathews | Completed | No outcome recorded |
| Phase 2 | NCT03515577 | Apr 2019 | prostate carcinoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03809078 | Jan 2019 → Mar 2022 | prostate cancer | Andrei Iagaru | Completed | No outcome recorded |
| Phase 2 | NCT03689582 | Nov 2018 → Feb 2020 | prostate cancer | University of Michigan Rogel Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT03439033 | Apr 2018 → May 2021 | prostate cancer | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 2 | NCT04050215 | Apr 2018 → Sep 2021 | metastatic prostate carcinoma, prostate adenocarcinoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03463889 | Mar 2018 → Sep 2020 | thyroid gland carcinoma | University of California, San Francisco | Terminated | No outcome recorded |
| Phase 2 | NCT03396874 | Feb 2018 → Aug 2022 | metastatic prostate carcinoma, prostate adenocarcinoma | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT02810886 | Oct 2016 → Jan 2017 | prostate cancer | Jules Bordet Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT02611882 | Dec 2015 → Oct 2016 | prostate cancer | Thomas Hope | Completed | No outcome recorded |
| Phase 2 | NCT02282137 | May 2015 → Dec 2022 | prostate cancer | Ebrahim Delpassand | Unknown | No outcome recorded |
| Phase 2/35 trials | ||||||
| Phase 2/3 | NCT07209878 | Jan 2020 → Dec 2025 overdue | prostate adenocarcinoma | First Affiliated Hospital of Fujian Medical University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02673151 | May 2017 → Apr 2018 | prostate adenocarcinoma | Andrei Iagaru | Completed | No outcome recorded |
| Phase 2/3 | NCT02919111 | Sep 2016 → Dec 2019 | prostate cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2/3 | NCT02918357 | Sep 2016 → Sep 2017 | prostate cancer | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2/3 | NCT02678351 | Apr 2016 → Dec 2020 | prostate adenocarcinoma | Andrei Iagaru | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT07052214 | Aug 2025 → Jun 2026 overdue | prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT05847348 | Jul 2023 → Dec 2025 overdue | prostate carcinoma | Telix Pharmaceuticals (Innovations) Pty Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT04838613 | Sep 2021 → Nov 2023 | prostate cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05744115 | Jul 2021 → Apr 2022 | prostate adenocarcinoma | Timothy Hoffman | Terminated | No outcome recorded |
| Phase 3 | NCT04684628 | Dec 2020 → Jan 2025 | prostate cancer | University of Saskatchewan | Suspended | No outcome recorded |
| Phase 3 | NCT03623425 | Feb 2019 → May 2020 | prostate cancer | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 3 | NCT03803475 | Oct 2018 → Aug 2020 | prostate cancer | Thomas Hope | Completed | No outcome recorded |
| Phase 3 | NCT03353740 | Sep 2017 → Sep 2020 | prostate cancer | Thomas Hope | Completed | No outcome recorded |
| Phase 3 | NCT03001869 | Jul 2017 → Jul 2023 | prostate cancer | Sir Mortimer B. Davis - Jewish General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02659527 | Jan 2016 → May 2022 | prostate cancer | Medical University of Vienna | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06355843 | Apr 2022 → Sep 2023 | prostate cancer | The First Affiliated Hospital of Anhui Medical University | Suspended | No outcome recorded |
| — | NCT05324332 | Apr 2022 → Jan 2025 overdue | prostate cancer | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT05170555 | Dec 2021 → Oct 2022 | renal cell carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| — | NCT05006326 | Aug 2021 → Dec 2023 | cancer | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| — | NCT03453528 | Jul 2017 → Dec 2024 | castration-resistant prostate carcinoma | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| — | NCT03187990 | Mar 2017 → Aug 2021 | prostate cancer | Irene Burger | Completed | No outcome recorded |
| — | NCT02920229 | Nov 2015 → Oct 2020 | prostate cancer | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT05415228 | — | prostate adenocarcinoma | Morand Piert, MD | No longer available | No outcome recorded |
| — | NCT04452136 | — | prostate cancer | Jeanne Link | Approved for marketing | No outcome recorded |
| — | NCT05002465 | — | metastatic prostate carcinoma | Dana Mathews | No longer available | No outcome recorded |
| — | NCT04854369 | — | castration-resistant prostate carcinoma | Tulane University | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04886986 Background | Jun 2021 → Dec 2027 expected | prostate cancer | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06881823 Comparator | Jun 2026 → Mar 2030 | prostate cancer | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05849298 Background | Jan 2024 → Dec 2026 expected | prostate neoplasm | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05658003 Background | May 2023 → Dec 2024 overdue | prostate carcinoma | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03675451 Background | Feb 2017 → Jun 2018 | prostate cancer | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05547386 Background | May 2022 → Dec 2023 | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Mayo Clinic | Completed | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 85 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | (68)Ga-PSMA-11 | “Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga(HBED-CC)] ((68)Ga-PSMA-11) is a PET tracer that can detect prostate cancer relapses and metastases by binding to the extracellular domain of PSMA.” PMID 26659347 ↗ Dec 201527“Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.” NCT04684628 ↗ “Injection of 68Ga PSMA-11” NCT05002465 ↗ |
| Known as | 68Ga PSMA-HBED-CC | “This is a study primarily comparing Magnetic Resonance Imaging (MRI) alone to Positron Emission Tomography (PET)/MRI using an experimental tracer, 68Ga-PSMA-HBED-CC, among men...” NCT03439033 ↗6“This is an expanded access program using 68Ga PSMA-HBED-CC (68Ga-PSMA-11).” NCT05415228 ↗ |
| Known as | 68Ga-HBED-CC-PSMA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03001869 ↗ |
| Known as | 68Ga-PSMA | “A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen...” NCT03001869 ↗15“To determine the feasibility and utility of Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA) PET imaging in patients with thyroid cancer.” NCT03463889 ↗ “100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT” NCT02920229 ↗ |
| Known as | 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11) | “68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11)” NCT02673151 ↗ |
| Known as | [68Ga]Ga-PSMA-11 | “two similar PET agents, [68Ga]Ga-P16-093 and [68Ga]Ga-PSMA-11, in the same group of primary prostate cancer (PCa) patients.” PMID 37233785 ↗ May 2023 |
| Known as | AAA517 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05849298 ↗ |
| Known as | DKFZ-11 | “A radiotracer in use today is 68Ga-HBED-CC-PSMA (DKFZ-11) - hereinafter abbreviated 68Ga-PSMA - which is a radiolabeled urea-based ligand for prostate specific membrane antigen...” NCT03001869 ↗ |
| Known as | Ga-68 labeled HBED-CC PSMA | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02611882 ↗ |
| Known as | Ga-68 labeled PSMA-11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02918357 ↗ |
| Known as | Ga-68-PSMA-11 | “The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detection prostate cancer in...” NCT03353740 ↗ |
| Known as | Gallium (68Ga) gozetotide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06881823 ↗ |
| Known as | gallium Ga 68 gozetotide | “Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11” NCT05558956 ↗ |
| Known as | Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02488070 ↗ |
| Known as | Gallium Ga 68-labeled PSMA-11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03515577 ↗ |
| Known as | Gallium Ga-labeled PSMA-11 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04976257 ↗ |
| Known as | Gallium-68 labeled HBED-CC PSMA | “Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) has recently been approved by the FDA for clinical use” NCT05415228 ↗ |
| Known as | Gallium-68 labeled PSMA-HBED-CC | “Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical” NCT03439033 ↗ |
| Known as | Gallium-68 PSMA-11 | “This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma” NCT03982407 ↗ |
| Known as | Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga(HBED-CC)] | “Glu-NH-CO-NH-Lys-(Ahx)-[(68)Ga(HBED-CC)] ((68)Ga-PSMA-11) is a PET tracer that can detect prostate cancer relapses and metastases by binding to the extracellular domain of PSMA.” PMID 26659347 ↗ Dec 2015 |
| Known as | Illuccix | “Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) 68Ga-PSMA-11” NCT05558956 ↗ |
| Known as | PSMA-HBED\_CC | “68Ga labeled PSMA -11 (or PSMA-HBED\_CC) PET/MRI scan” NCT03982407 ↗ |
| Modality | Diagnostic / imaging agent | “68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan” NCT02282137 ↗ |
| Route | Intravenous | “Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV)” NCT02488070 ↗ |