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ga-68-dota-toc

Trade name: Ga-68-dota-toc

Small moleculeapprovedImaging agentOrphan Drug FDA

Approved

Aug 21, 2019

Clinical trial activity

18 trials · 18 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
9
Phase 3
5
Phase 4
0

Earliest trial started Oct 1, 2011 (NCT01460706)

Timeline

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Oct 25, 2013

    Orphan Drug Designation

  3. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2015

    Earliest Phase 3 Sponsor(trial)

  5. Aug 21, 2019

    University of Iowa — Earliest FDA Approval

  6. Aug 21, 2019

    University of Iowa — NDA Organization

  7. Aug 21, 2019

    University of Iowa — Marketing Organization

2020s

  1. Oct 10, 2025

    Methodist Cancer Center, Houston, Texas — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 21, 2019

Chemistry & pharmacology

Imaging
68-Gallium

Oral

No

Parenteral

No

Topical

No

Also known as

  • 67ga-dotatoc
  • 68ga-dota(0)-phe(1)-tyr(3)-octreotide
  • 68ga dotatoc
  • 68ga-dotatoc
  • 68ga-dotatoc
  • ga-68-dota-toc
  • ga-dota(0)-phe(1)-tyr(3)-octreotide
  • ga(iii)-dotatoc
  • gallium-68 dotatoc
  • gallium-68 dotatoc

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07178938Phase 2Apr 30, 2026MedSIR
NCT06982300Phase 1/Phase 2 (Phase 2)Sep 25, 2025University of Groningen
NCT06611891Phase 3Oct 31, 2024University of Grenoble
NCT06091748Phase 3Nov 1, 2023Hengrui Therapeutics, Inc.
NCT05183555Phase 2Apr 30, 2022University of Lorraine
NCT04298541Phase 2Apr 30, 2020Cornell University
NCT03347760N/AMar 30, 2018University of Lorraine
NCT03197012Early Phase 1 (Phase 1)Jul 1, 2017University of California, San Francisco
NCT03057509N/AFeb 1, 2017Harvard University
NCT03001349N/ADec 20, 2016University of Texas at Houston
NCT03136328Phase 3May 16, 2016NCM USA, Yeshiva University
NCT02441062Phase 2Sep 1, 2015University of Iowa
NCT02375464N/AApr 1, 2015Lenox Hill Hospital, Northwell Health
NCT02358018N/AFeb 3, 2015Cornell University
NCT02419664Phase 3Jan 31, 2015University of Gothenburg, Uppsala University
NCT02359500Phase 1Dec 1, 2014Icahn School of Medicine at Mount Sinai
NCT01619865N/AFeb 1, 2012University of Iowa
NCT01460706Phase 2/Phase 3 (Phase 3)Oct 1, 2011University of Turku
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Cornell UniversityAcademic/Hospital2222015
University of IowaAcademic/Hospital2222012
University of LorraineAcademic/Hospital2222018
Harvard UniversityAcademic/Hospital1112017
Hengrui Therapeutics, Inc.For profit1112023
Icahn School of Medicine at Mount SinaiAcademic/Hospital1112014
Lenox Hill HospitalAcademic/Hospital1012015
MedSIRAcademic/Hospital1112026
NCM USAFor profit1012016
Northwell HealthAcademic/Hospital1112015
University of California, San FranciscoAcademic/Hospital1112017
University of GothenburgAcademic/Hospital1112015
University of GrenobleAcademic/Hospital1112024
University of GroningenAcademic/Hospital1112025
University of Texas at HoustonAcademic/Hospital1112016
University of TurkuAcademic/Hospital1112011
Uppsala UniversityAcademic/Hospital1012015
Yeshiva UniversityAcademic/Hospital1112016
18 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Methodist Cancer Center, Houston, TexasAcademic/HospitalMKTGOct 10, 2025
University of IowaAcademic/HospitalNDAAug 21, 2019
University of IowaAcademic/HospitalMKTGAug 21, 2019