CDEK
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abatacept

Trade name: orencia

Recombinant proteinapproved

Approved

Dec 23, 2005

Abatacept, sold under the brand name Orencia, is a medication used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the immune activity of T cells. It is a modified antibody. — Wikipedia

Clinical trial activity

191 trials · 125 clinical orgs · 1 marketing orgs

Phase 1
46
Phase 2
125
Phase 3
54
Phase 4
29

Earliest trial started Aug 1, 1995 (NCT00306878)

Timeline

1990s

  1. Jan 1, 1995

    Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1997

    Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  2. Dec 23, 2005

    Bristol-Myers Squibb — Earliest FDA Approval

  3. Dec 23, 2005

    Bristol-Myers Squibb — Marketing Organization

  4. Dec 23, 2005

    Bristol-Myers Squibb — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 23, 2005

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept
  • abatacept recombinant
  • bms 188667
  • bms-188667
  • bms-188667
  • bms-188667
  • ctla-4 ig
  • ctla4-igg4m
  • orencia
  • orencia
  • orencia
  • orencia
  • orencia clickject
  • rg-1046
  • rg2077
  • rg-2077

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07111468Phase 3Oct 17, 2025Yuhan Pharmaceutical Company
NCT07138898Phase 2Sep 30, 2025New York University
NCT06731504Early Phase 1 (Phase 1)Jul 31, 2025Duke University
NCT06859424Phase 2Jul 25, 2025Center for International Blood and Marrow Transplant Research, Incyte, National Marrow Donor Program
NCT07238712Phase 2May 10, 2025Pavlov First Saint Petersburg State Medical University
NCT06654882Phase 3Feb 28, 2025Duke University, Patient-Centered Outcomes Research Institute
NCT06680661Phase 2Nov 15, 2024Case Western Reserve University
NCT06623526Phase 1Oct 4, 2024Jeonbuk National University, Yuhan Pharmaceutical Company
NCT06681922Phase 1/Phase 2 (Phase 2)Sep 23, 2024Northwell Health
NCT06929039Phase 1Jul 4, 2024Kashiv BioSciences, LLC
NCT06395038Phase 1May 6, 2024The University of Texas, Dallas
NCT06279494Phase 1/Phase 2 (Phase 2)Mar 31, 2024Peking University
NCT06145282Phase 1/Phase 2 (Phase 2)Jan 3, 2024National Heart, Lung, and Blood Institute (NHLBI)
NCT05917522Phase 2Nov 30, 2023Cedars-Sinai Medical Center, National Institute of Allergy and Infectious Diseases (NIAID)
NCT05981976Phase 1Aug 15, 2023Bristol-Myers Squibb
NCT05975450Phase 1Aug 2, 2023Emory University, National Institute of Allergy and Infectious Diseases (NIAID)
NCT05822583Phase 4Jul 6, 2023University of Copenhagen, University of Minnesota
NCT05742243Phase 2Feb 13, 2023Juvenile Diabetes Research Foundation, Melbourne Health, National Health and Medical Research Council, Australia
NCT05428488Phase 3Nov 28, 2022University of Montpellier
NCT05195645Phase 2Oct 4, 2022Assistance Publique - Hôpitaux de Paris, Hôpital Saint Antoine - PARIS
Showing 20 of 191 trials
Page 1 / 10

Organizations

Research & Development (125)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit1035951995
National Institute of Allergy and Infectious Diseases (NIAID)Government11722003
Harvard UniversityAcademic/Hospital8632003
New York UniversityAcademic/Hospital7632012
Columbia UniversityAcademic/Hospital6532004
Emory UniversityAcademic/Hospital6622005
Juvenile Diabetes Research FoundationAcademic/Hospital6022005
National Institutes of Health (NIH)Government6022008
Duke UniversityAcademic/Hospital5522019
Immune Tolerance NetworkAcademic/Hospital5022003
University of Erlangen-NurembergAcademic/Hospital5532009
University of California, Los AngelesAcademic/Hospital4442011
University of PennsylvaniaAcademic/Hospital4232008
University of RochesterAcademic/Hospital4122008
Karolinska InstituteAcademic/Hospital3322011
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3312008
University of LondonAcademic/Hospital3222007
University of WashingtonAcademic/Hospital3232013
AbbVieFor profit2122017
American Diabetes AssociationAcademic/Hospital2012008
125 organizations
Page 1 / 7

Marketing (2)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitMKTGDec 23, 2005
Bristol-Myers SquibbFor profitNDADec 23, 2005