gallium citrate ga 67

Small moleculeapprovedImaging agent

Approved

May 17, 1976

Gallium citrate Ga 67 is the citrate salt of the radioisotope gallium Ga 67. Although the mechanism is unknown, gallium Ga 67 concentrates in lysosomes and is bound to a soluble intracellular protein in certain viable primary and metastatic tumors and focal sites of inflammation, allowing scintigraphic localization. Ga-67 scintigraphy (GS) cannot differentiate between tumor and acute inflammation. Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state. — NCATS

Clinical trial activity

8 trials · 8 clinical orgs · 3 marketing orgs

Phase 1
3
Phase 2
4
Phase 3
1
Phase 4
0

Earliest trial started May 1, 2007 (NCT00477503)

Timeline

1970s

  1. May 17, 1976

    Lantheus Medical Imaging — Earliest FDA Approval

  2. May 17, 1976

    Lantheus Medical Imaging — NDA Secondary Org

  3. May 17, 1976

    Lantheus Medical Imaging — NDA Organization

  4. Dec 16, 1977

    General Electric — NDA Secondary Org

  5. Feb 1, 1979

    Curium Pharma — NDA Secondary Org

2000s

  1. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewMay 17, 1976

Chemistry & pharmacology

Loading structure…

SMILES

[67Ga+3]
Mol. weight
258.82 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
67-gallium

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 67ga
  • 67ga
  • (68)ga-citrate
  • 68gallium citrate
  • ga-67 citrate
  • gallium-67 citrate
  • gallium-67 citrate
  • gallium-67 citrate
  • gallium-67 citrate
  • gallium-67-citrate
  • gallium(67) citrate
  • gallium (67 ga) citrate
  • gallium (67 ga) citrate
  • gallium (67ga) citrate
  • gallium citrate
  • gallium citrate
  • gallium citrate
  • gallium citrate
  • gallium citrate (1:1); 67ga-labeled
  • gallium citrate (67ga)
  • gallium citrate, 67ga-labeled
  • gallium citrate ga 67
  • gallium citrate ga 67
  • gallium citrate ga 67
  • gallium citrate ga 67
  • gallium citrate ga-67
  • gallium citrate ga-67
  • gallium citrate ga-67
  • neoscan
  • neoscan

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04139395Phase 3Jan 15, 2019Stanford University
NCT03669614Phase 1/Phase 2 (Phase 2)Oct 31, 2018Aridis Pharmaceuticals, Inc.
NCT03123289Phase 2Mar 6, 2017Rutgers University
NCT03116945Phase 2Jun 1, 2016Radiological Society of North America, Rutgers University
NCT02776891N/AMay 1, 2016University of California, San Francisco
NCT02391025Early Phase 1 (Phase 1)May 28, 2015Department of Defense, University of California, San Francisco
NCT01951300N/ASep 30, 2013University of Turku
NCT00477503Phase 1May 1, 2007University of Texas at Houston
Showing 8 of 8 trials
Page 1 / 1

Organizations

Research & Development (8)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Rutgers UniversityAcademic/Hospital2212016
University of California, San FranciscoAcademic/Hospital2222015
Aridis Pharmaceuticals, Inc.For profit1112018
Department of DefenseGovernment1012015
Radiological Society of North AmericaAcademic/Hospital1012016
Stanford UniversityAcademic/Hospital1112019
University of Texas at HoustonAcademic/Hospital1112007
University of TurkuAcademic/Hospital1112013
8 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Curium PharmaFor profitNDA2Feb 1, 1979
General ElectricFor profitNDA2Dec 16, 1977
Lantheus Medical ImagingFor profitNDA2May 17, 1976
Lantheus Medical ImagingFor profitNDAMay 17, 1976