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lymphocyte immune globulin, anti-thymocyte globulin (equine)

Trade name: Atgam

Animal productapproved

Approved

Nov 17, 1981

The Teke people or Bateke, also known as the Tyo or Tio, are a Bantu Central African ethnic group that speak the Teke languages and that mainly inhabit the south, north, and center of the Republic of the Congo, the west of the Democratic Republic of the Congo, with a minority in the south-east of Gabon. Omar Bongo, who was President of Gabon in the late 20th century, was a Teke. — Wikipedia

Clinical trial activity

17 trials · 26 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
15
Phase 3
4
Phase 4
0

Earliest trial started Jun 1, 2005 (NCT00114530)

Timeline

1980s

  1. Nov 17, 1981

    Earliest FDA Approval

1990s

  1. Dec 4, 1996

    Pharmacia & Upjohn — First NDA Organization

  2. Dec 4, 1996

    Pharmacia & Upjohn — NDA Secondary Org

  3. Dec 4, 1996

    Pharmacia & Upjohn — NDA Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • ThymocytesImmunity, passive

    Thymocytes immunity, passive

  • Unspecified targetUnclear

    unclear

Approval history

  • approvedNov 17, 1981

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • antilymphocyte immunoglobulin (horse)
  • anti-thymocyte globulin equine
  • anti-thymocyte globulin (equine)
  • atege
  • atgam
  • atgam
  • eatg
  • equine antithymocyte globulin
  • equine atg
  • equine thymocyte immune globulin
  • hatg
  • horse anti-thymocyte globulin
  • horse anti-thymocyte globulin
  • horse atg
  • lymphocyte immune globulin, anti-thymocyte globulin
  • lymphocyte immune globulin anti-thymocyte globulin (equine)
  • lymphocyte immune globulin, anti-thymocyte globulin (equine)

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05600426Phase 3Dec 31, 2022Blood and Marrow Transplant Clinical Trials Network, Center for International Blood and Marrow Transplant Research, Harvard University, Medical College of Wisconsin, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Utah
NCT04862221Phase 2Jan 31, 2022Medical University of South Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Northwestern University
NCT05132166Phase 2Nov 30, 2021University of Toronto
NCT04370795Phase 1/Phase 2 (Phase 2)May 27, 2020National Institute of Allergy and Infectious Diseases (NIAID)
NCT04350606Phase 3May 15, 2020Pfizer
NCT04304820Phase 2Apr 23, 2020National Heart, Lung, and Blood Institute (NHLBI)
NCT04224558Phase 1/Phase 2 (Phase 2)Jan 1, 2020Cedars-Sinai Medical Center
NCT03663933Phase 2Sep 4, 2018National Cancer Institute (NCI)
NCT02845596N/AAug 1, 2016Children's Hospital Los Angeles, Harvard University, University of Southern California
NCT02462252Phase 2Oct 1, 2015BioLineRx, Ltd., University of Texas at Houston
NCT01861106Phase 2Apr 26, 2013National Cancer Institute (NCI)
NCT01623167Phase 1/Phase 2 (Phase 2)Jun 7, 2012National Heart, Lung, and Blood Institute (NHLBI)
NCT01453218Phase 3Oct 1, 2011Universidad Autonoma de Barcelona
NCT01049854Phase 2Sep 1, 2011New York Medical College
NCT00944749Phase 2Jul 1, 2009National Heart, Lung, and Blood Institute (NHLBI)
NCT00923364Phase 2Mar 5, 2009National Cancer Institute (NCI)
NCT00114530Phase 2/Phase 3 (Phase 3)Jun 1, 2005Duke University, National Institute of Allergy and Infectious Diseases (NIAID), Presbyterian/St. Luke's Medical Center, Denver, University of California, Los Angeles, University of Kentucky, University of Texas at Houston, University of Washington
Showing 17 of 17 trials
Page 1 / 1

Organizations

Research & Development (26)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government4322009
National Cancer Institute (NCI)Government3312009
Harvard UniversityAcademic/Hospital2122016
National Institute of Allergy and Infectious Diseases (NIAID)Government2222005
University of Texas at HoustonAcademic/Hospital2022005
BioLineRx, Ltd.For profit1112015
Blood and Marrow Transplant Clinical Trials NetworkAcademic/Hospital1012022
Cedars-Sinai Medical CenterAcademic/Hospital1112020
Center for International Blood and Marrow Transplant ResearchGovernment1012022
Children's Hospital Los AngelesAcademic/Hospital1112016
Duke UniversityAcademic/Hospital1012005
Medical College of WisconsinAcademic/Hospital1012022
Medical University of South CarolinaAcademic/Hospital1012022
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government1112022
National Institutes of Health (NIH)Government1012022
New York Medical CollegeAcademic/Hospital1112011
Northwestern UniversityAcademic/Hospital1012022
PfizerFor profit1112020
Presbyterian/St. Luke's Medical Center, DenverAcademic/Hospital1012005
Universidad Autonoma de BarcelonaAcademic/Hospital1112011
26 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
Pharmacia & UpjohnFor profitNDA2Dec 4, 1996
Pharmacia & UpjohnFor profitNDADec 4, 1996