Ga 68 PSMA-11

Trade name: Illuccix

Small moleculeapprovedImaging agent

Approved

Dec 1, 2020

Clinical trial activity

119 trials · 74 clinical orgs · 5 marketing orgs

Phase 1
36
Phase 2
69
Phase 3
23
Phase 4
0

Earliest trial started Apr 1, 2015 (NCT02282137)

Timeline

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2016

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 1, 2020

    University of California, Los Angeles — Earliest FDA Approval

  2. Dec 1, 2020

    University of California, Los Angeles — Marketing Organization

  3. Dec 1, 2020

    University of California, San Francisco — Marketing Organization

  4. Dec 1, 2020

    University of California, Los Angeles — NDA Secondary Org

  5. Dec 1, 2020

    University of California, San Francisco — NDA Secondary Org

  6. Dec 1, 2020

    University of California, Los Angeles — NDA Organization

  7. Dec 17, 2021

    Telix — Marketing Organization

  8. Dec 17, 2021

    Telix — NDA Secondary Org

  9. Mar 23, 2022

    Novartis — Marketing Organization

  10. Mar 23, 2022

    Novartis — NDA Secondary Org

  11. May 14, 2026

    Ionetix — Marketing Organization

Indications

Mechanism of action

  • 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

Loading structure…

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

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 IDPhaseStart dateSponsor(s)
NCT06881823Phase 1/Phase 2 (Phase 2)Jun 29, 2026Novartis
NCT07310355Phase 1/Phase 2 (Phase 2)Dec 30, 2025Government of China
NCT07150715Phase 2Oct 31, 2025Novartis, University of California, Los Angeles
NCT07052214Phase 3Aug 18, 2025Telix
NCT07301827N/AJun 1, 2025Huazhong University of Science and Technology
NCT07056790Phase 1/Phase 2 (Phase 2)May 15, 2025Fujian Medical University
NCT07117760Phase 1/Phase 2 (Phase 2)Apr 22, 2025Fujian Medical University
NCT06659926N/ADec 1, 2024Bayer, Netherlands Cancer Institute, University of Amsterdam
NCT06560905Phase 2Sep 1, 2024Royal Marsden Hospital NHS Trust
NCT06521775Phase 2Aug 12, 2024Mayo Clinic
NCT06216249Phase 2Aug 1, 2024University of California, Los Angeles
NCT06288113Phase 2Aug 1, 2024Novartis, University of California, Los Angeles
NCT06379217Phase 1Jul 29, 2024Novartis
NCT06444412Phase 2Jul 26, 2024Mayo Clinic
NCT06200103Phase 2May 3, 2024Mayo Clinic
NCT06462508Early Phase 1 (Phase 1)Apr 20, 2024Anhui Medical University, Anhui Province Cancer Hospital
NCT06145633Phase 2Apr 1, 2024National Cancer Institute (NCI), Novartis, University of Washington
NCT06437496Early Phase 1 (Phase 1)Apr 1, 2024Fujian Medical University
NCT06044857Phase 1Feb 29, 2024Telix, The University of Texas, Dallas
NCT06004661Phase 2Dec 29, 2023Novartis
Showing 20 of 119 trials
Page 1 / 6

Organizations

Research & Development (74)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of California, Los AngelesAcademic/Hospital121242016
National Cancer Institute (NCI)Government11042015
NovartisFor profit11832021
University of California, San FranciscoAcademic/Hospital101042015
Mayo ClinicAcademic/Hospital9922019
Chinese Academy of Medical SciencesAcademic/Hospital7742020
Stanford UniversityAcademic/Hospital6622015
Fujian Medical UniversityAcademic/Hospital5532020
TelixFor profit5222021
Cornell UniversityAcademic/Hospital4422016
The University of Texas, DallasAcademic/Hospital4432019
University of IowaAcademic/Hospital4422016
Anhui Medical UniversityAcademic/Hospital3322022
Chang Gung UniversityAcademic/Hospital3312017
University of MichiganAcademic/Hospital3322018
Anhui Province Cancer HospitalAcademic/Hospital2012023
General ElectricFor profit2012019
Huazhong University of Science and TechnologyAcademic/Hospital2212021
Istituto Nazionale per lo Studio e la Cura dei TumoriAcademic/Hospital2212015
McGill UniversityAcademic/Hospital2222016
74 organizations
Page 1 / 4

Marketing (13)

OrganizationOrg typeRelationshipDate
IonetixFor profitMKTGMay 14, 2026
NovartisFor profitMKTGMar 23, 2022
NovartisFor profitNDA2Mar 23, 2022
NovartisFor profitSYNMar 23, 2022
TelixFor profitMKTGDec 17, 2021
TelixFor profitNDA2Dec 17, 2021
TelixFor profitSYNMar 20, 2025
University of California, Los AngelesAcademic/HospitalMKTGDec 1, 2020
University of California, Los AngelesAcademic/HospitalMKTGDec 1, 2020
University of California, Los AngelesAcademic/HospitalNDA2Dec 1, 2020
University of California, Los AngelesAcademic/HospitalNDADec 1, 2020
University of California, San FranciscoAcademic/HospitalMKTGDec 1, 2020
University of California, San FranciscoAcademic/HospitalNDA2Dec 1, 2020