CDEK
← All drugs Report issue

gallium-68-dotatate

Trade name: netspot

Small moleculeapprovedImaging agentOrphan Drug FDA

Approved

Jun 1, 2016

Dotatate gallium (Ga-68) (Ga-DOTATATE ) under the brand name NETSPOT is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. In addition, was shown, that Ga-DOTATATE can be used for detection the incidental medullary thyroid carcinoma. It binds to cells that express somatostatin receptors including malignant cells, which overexpress somatostatin subtype 2 receptors. — NCATS

Clinical trial activity

42 trials · 29 clinical orgs · 2 marketing orgs

Phase 1
21
Phase 2
25
Phase 3
3
Phase 4
1

Earliest trial started Dec 15, 1993 (NCT00001277)

Timeline

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  2. Dec 31, 2013

    Orphan Drug Designation

  3. Jun 1, 2016

    Advanced Accelerator Applications — Earliest FDA Approval

  4. Jun 1, 2016

    AAA Pharmaceutical — NDA Secondary Org

  5. Jun 1, 2016

    Advanced Accelerator Applications — NDA Organization

  6. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • SomatostatinBINDING AGENT

    SST binding agent

  • Unspecified targetOTHER

    Diagnostic

    Somatostatin binding substance used to visualise neuroendocrine tumours when radiolabelled

  • Unspecified targetOTHER

    Diagnostic agent

    Radioactive diagnostic agent. A radionuclide that binds to malignant neuroendocrine cells which overexpress sstr2 receptors allowing positron emission tomography (PET) imaging.

    Highest affinity for subtype 2 receptors.

Approval history

  • approvedPriority reviewJun 1, 2016

Chemistry & pharmacology

Loading structure…

SMILES

[68Ga+3].CC(O)[C@H](NC(=O)[C@@H]1CSSC[C@H](NC(=O)[C@@H](CC2=CC=CC=C2)NC(=O)CN3CCN(CC([O-])=O)CCN(CC([O-])=O)CCN(CC([O-])=O)CC3)C(=O)N[C@@H](CC4=CC=C(O)C=C4)C(=O)N[C@H](CC5=CNC6=C5C=CC=C6)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1)C(O)=O
Mol. weight
1500.527 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Imaging
68-gallium

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (68ga-dota-3-iodo-tyr(3),thr(8))octreotide
  • 68ga-dota-iodo-tyr(3)-octreotate
  • 68ga dotatate
  • 68ga dotatate
  • 68ga-dotatate
  • 68ga-dotatate
  • 68ga-dotatate
  • (68ga)gallium dotatate
  • 68ga-ha-dotatate
  • 68ga-ha-dotatate
  • 68gallium-dota-tyr(3)-thr(8)-octreotate
  • dotatate gallium ga-68
  • edotreotide gallium ga-68
  • ga-68 dota0-tyr3-octreotide
  • ga-68 dota0-tyr3-octreotide
  • ga-68 dotatoc
  • ga-dotatate
  • gallium 68 dota-octreotide
  • gallium 68 dotatate
  • gallium-68-dotatate
  • gallium-68-dotatate
  • gallium (68ga) dota-tate
  • gallium (68ga) edotreotide
  • gallium-dota-octreotate, ga-68
  • gallium dotatate ga-68
  • gallium dotatate ga-68
  • gallium dotatate, ga-68
  • gallium edotreotide ga-68
  • gallium ga 68 dotatate
  • gallium ga 68-dotatoc
  • gallium ga 68-edotreotide
  • gallium ga 68-edotreotide
  • gallium ga-68 edotreotide
  • netspot
  • netspot

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07284589Phase 2Dec 11, 2025—
NCT06479811Phase 1Nov 17, 2024National Cancer Institute (NCI)
NCT06427798Phase 1/Phase 2 (Phase 2)Nov 17, 2024National Cancer Institute (NCI)
NCT07288931N/AAug 6, 2024Chinese Academy of Medical Sciences
NCT06379217Phase 1Jul 29, 2024Novartis
NCT06240741Phase 3Mar 21, 2024Eckert & Ziegler Radiopharma GmbH, Novartis
NCT07119242Phase 3Jan 8, 2024—
NCT06520319Phase 1Jun 21, 2023Fujian Medical University
NCT05880394Phase 1Jan 10, 2023Hoag Memorial Hospital Presbyterian
NCT05990998Phase 1/Phase 2 (Phase 2)Nov 20, 2022Fujian Medical University
NCT05536960N/ASep 9, 2022University of Amsterdam
NCT05142696Phase 1Mar 11, 2022Novartis
NCT05109728Phase 1Feb 14, 2022Novartis
NCT04927416Phase 2Oct 25, 2021National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT04888481Phase 2Sep 1, 2021University of Alberta
NCT04609592Phase 1Mar 17, 2021Novartis, Stanford University
NCT04559217Phase 2Nov 15, 2020Ciusss de L'Est de l'Île de Montréal, University of Sherbrooke
NCT04298541Phase 2Apr 30, 2020Cornell University
NCT04074135Phase 2Apr 23, 2020National Cancer Institute (NCI)
NCT04689893Phase 1Mar 15, 2020Chinese Academy of Medical Sciences
Showing 20 of 42 trials
Page 1 / 3

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government6522013
NovartisFor profit5422021
Chinese Academy of Medical SciencesAcademic/Hospital3322014
Mayo ClinicAcademic/Hospital3332018
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3211993
Stanford UniversityAcademic/Hospital3332013
Fujian Medical UniversityAcademic/Hospital2222022
University of Alabama, BirminghamAcademic/Hospital2222018
University of AlbertaAcademic/Hospital2112017
University of California, Los AngelesAcademic/Hospital2222013
AHS Cancer Control AlbertaAcademic/Hospital1112017
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112019
Ciusss de L'Est de l'Île de MontréalAcademic/Hospital1012020
Cornell UniversityAcademic/Hospital1112020
Eckert & Ziegler Radiopharma GmbHAcademic/Hospital1012024
Emory UniversityAcademic/Hospital1112018
Excel Diagnostics and Nuclear Oncology CenterAcademic/Hospital1012013
Hoag Memorial Hospital PresbyterianAcademic/Hospital1112023
National Institutes of Health (NIH)Government1112013
Ochsner Health SystemAcademic/Hospital1112014
29 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
AAA PharmaceuticalFor profitNDA2Jun 1, 2016
Advanced Accelerator ApplicationsFor profitNDAJun 1, 2016