Ga 68 PSMA-11
Trade name: Illuccix
Approved
Dec 1, 2020
Clinical trial activity
119 trials · 74 clinical orgs · 5 marketing orgs
Earliest trial started Apr 1, 2015 (NCT02282137)
Timeline
2010s
2020s
- Dec 1, 2020
University of California, Los Angeles — Earliest FDA Approval
- Dec 1, 2020
University of California, Los Angeles — Marketing Organization
- Dec 1, 2020
University of California, San Francisco — Marketing Organization
- Dec 1, 2020
University of California, Los Angeles — NDA Secondary Org
- Dec 1, 2020
University of California, San Francisco — NDA Secondary Org
- Dec 1, 2020
University of California, Los Angeles — NDA Organization
- Dec 17, 2021
Telix — Marketing Organization
- Dec 17, 2021
Telix — NDA Secondary Org
- Mar 23, 2022
Novartis — Marketing Organization
- Mar 23, 2022
Novartis — NDA Secondary Org
- May 14, 2026
Ionetix — Marketing Organization
Indications
Approved for
Studied for
- Breast Neoplasms · Phase 1
- Carcinoma, Adenoid Cystic · Phase 2
- Carcinoma, Hepatocellular · Phase 2
- Diagnostic Imaging · Phase 3
- Glioma · Phase 2
- Melanoma · Phase 2
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 2
- Ovarian Neoplasms · Early Phase 1
- Passive Cutaneous Anaphylaxis · Phase 3
- Positron-Emission Tomography · Phase 3
- Positron Emission Tomography Computed Tomography · Early Phase 1
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Recurrence · Phase 3
- Sarcoma · Phase 1
- Thyroid Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 1
Mechanism of action
- Glutamate carboxypeptidase IIBINDING AGENT
FOLH1 binding agent
- Unspecified targetOTHER
Diagnostic agent
Radioactive diagnostic agent that binds to cells expressing prostate-specific membrane antigen (PSMA), including malignant prostate cancer cells. Indicated for positron emission tomography of PSMA-positive lesions.
Approval history
- approvedDec 1, 2020
Chemistry & pharmacology
SMILES
O=C([O-])CN(CCN(CC(=O)[O-])Cc1cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc1[O-])Cc1cc(CCC(=O)O)ccc1[O-].[68Ga+3].[OH3+]- Mol. weight
- 1029.92 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL5095039 ↗
Also known as
- 68ga hbed-cc psma
- 68ga-hbed-cc-psma
- 68ga-psma
- 68ga psma-hbed-cc
- 68ga-psma-hbed-cc
- ga 68-labeled psma ligand glu-urea-lys(ahx)
- ga 68-labeled psma ligand glu-urea-lys(ahx)-hbed-cc
- ga 68-psma
- ga68 psma-11
- ga-hbed-ipsma
- gallium-68 psma-11
- gallium-68 psma-hbed-cc
- psma-11
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06881823 | Phase 1/Phase 2 (Phase 2) | Jun 29, 2026 | Novartis |
| NCT07310355 | Phase 1/Phase 2 (Phase 2) | Dec 30, 2025 | Government of China |
| NCT07150715 | Phase 2 | Oct 31, 2025 | Novartis, University of California, Los Angeles |
| NCT07052214 | Phase 3 | Aug 18, 2025 | Telix |
| NCT07301827 | N/A | Jun 1, 2025 | Huazhong University of Science and Technology |
| NCT07056790 | Phase 1/Phase 2 (Phase 2) | May 15, 2025 | Fujian Medical University |
| NCT07117760 | Phase 1/Phase 2 (Phase 2) | Apr 22, 2025 | Fujian Medical University |
| NCT06659926 | N/A | Dec 1, 2024 | Bayer, Netherlands Cancer Institute, University of Amsterdam |
| NCT06560905 | Phase 2 | Sep 1, 2024 | Royal Marsden Hospital NHS Trust |
| NCT06521775 | Phase 2 | Aug 12, 2024 | Mayo Clinic |
| NCT06216249 | Phase 2 | Aug 1, 2024 | University of California, Los Angeles |
| NCT06288113 | Phase 2 | Aug 1, 2024 | Novartis, University of California, Los Angeles |
| NCT06379217 | Phase 1 | Jul 29, 2024 | Novartis |
| NCT06444412 | Phase 2 | Jul 26, 2024 | Mayo Clinic |
| NCT06200103 | Phase 2 | May 3, 2024 | Mayo Clinic |
| NCT06462508 | Early Phase 1 (Phase 1) | Apr 20, 2024 | Anhui Medical University, Anhui Province Cancer Hospital |
| NCT06145633 | Phase 2 | Apr 1, 2024 | National Cancer Institute (NCI), Novartis, University of Washington |
| NCT06437496 | Early Phase 1 (Phase 1) | Apr 1, 2024 | Fujian Medical University |
| NCT06044857 | Phase 1 | Feb 29, 2024 | Telix, The University of Texas, Dallas |
| NCT06004661 | Phase 2 | Dec 29, 2023 | Novartis |
Organizations
Research & Development (74)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| University of California, Los Angeles | Academic/Hospital | 12 | 12 | 4 | 2016 |
| National Cancer Institute (NCI) | Government | 11 | 0 | 4 | 2015 |
| Novartis | For profit | 11 | 8 | 3 | 2021 |
| University of California, San Francisco | Academic/Hospital | 10 | 10 | 4 | 2015 |
| Mayo Clinic | Academic/Hospital | 9 | 9 | 2 | 2019 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 7 | 7 | 4 | 2020 |
| Stanford University | Academic/Hospital | 6 | 6 | 2 | 2015 |
| Fujian Medical University | Academic/Hospital | 5 | 5 | 3 | 2020 |
| Telix | For profit | 5 | 2 | 2 | 2021 |
| Cornell University | Academic/Hospital | 4 | 4 | 2 | 2016 |
| The University of Texas, Dallas | Academic/Hospital | 4 | 4 | 3 | 2019 |
| University of Iowa | Academic/Hospital | 4 | 4 | 2 | 2016 |
| Anhui Medical University | Academic/Hospital | 3 | 3 | 2 | 2022 |
| Chang Gung University | Academic/Hospital | 3 | 3 | 1 | 2017 |
| University of Michigan | Academic/Hospital | 3 | 3 | 2 | 2018 |
| Anhui Province Cancer Hospital | Academic/Hospital | 2 | 0 | 1 | 2023 |
| General Electric | For profit | 2 | 0 | 1 | 2019 |
| Huazhong University of Science and Technology | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | Academic/Hospital | 2 | 2 | 1 | 2015 |
| McGill University | Academic/Hospital | 2 | 2 | 2 | 2016 |
Marketing (13)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ionetix | For profit | MKTG | May 14, 2026 |
| Novartis | For profit | MKTG | Mar 23, 2022 |
| Novartis | For profit | NDA2 | Mar 23, 2022 |
| Novartis | For profit | SYN | Mar 23, 2022 |
| Telix | For profit | MKTG | Dec 17, 2021 |
| Telix | For profit | NDA2 | Dec 17, 2021 |
| Telix | For profit | SYN | Mar 20, 2025 |
| University of California, Los Angeles | Academic/Hospital | MKTG | Dec 1, 2020 |
| University of California, Los Angeles | Academic/Hospital | MKTG | Dec 1, 2020 |
| University of California, Los Angeles | Academic/Hospital | NDA2 | Dec 1, 2020 |
| University of California, Los Angeles | Academic/Hospital | NDA | Dec 1, 2020 |
| University of California, San Francisco | Academic/Hospital | MKTG | Dec 1, 2020 |
| University of California, San Francisco | Academic/Hospital | NDA2 | Dec 1, 2020 |