Abatacept
Other / unclassified targets CD28, CD80, CD86 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | ORENCIA | — | 2007-03-13 – 2023-10-30 | fda.gov ↗ |
| Approved | EU (EMA) | Orencia | — | 2007-05-21 | europa.eu ↗ |
| Approved | US (FDA) | ORENCIA | — | 2005-12-23 | fda.gov ↗ |
Trials 145 · started per year
Also used as a comparator or background therapy in 54 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06929039 Comparator | Jul → Oct 2024 | rheumatoid arthritis | Kashiv BioSciences, LLC | Completed | No outcome recorded |
| Phase 1 | NCT06395038 Comparator | May 2024 → Apr 2026 | frontotemporal dementia | The Methodist Hospital Research Institute | Unknown | No outcome recorded |
| Phase 1 | NCT02923583 Comparator | Oct 2016 → Jul 2017 | — | Momenta Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00279734 Comparator | Aug 2004 → Jan 2005 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT06279494 Background | Mar → Jun 2024 | acute leukemia, aplastic anemia, myelodysplastic syndrome | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT06145282 Background | Dec 2023 → Oct 2025 overdue | sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02429934 Comparator | Oct 2015 → Sep 2019 | systemic lupus erythematosus | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 1/2 | NCT00254293 Comparator | Jan 2006 → May 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT07616154 Background | Sep 2026 → Sep 2034 expected | sickle cell disease | St. Jude Children's Research Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03929601 Comparator | Oct 2023 → Mar 2027 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05742243 Comparator | Feb 2023 → Sep 2025 | type 1 diabetes mellitus | Melbourne Health | Completed | No outcome recorded |
| Phase 2 | NCT03784261 Comparator | Dec 2018 → Dec 2022 | rheumatoid arthritis | Shinshu University | Unknown | No outcome recorded |
| Phase 2 | NCT03411850 Comparator | May 2016 → May 2021 | Sjogren syndrome | Arthritis & Rheumatism Associates, P.C. | Unknown | No outcome recorded |
| Phase 2 | NCT02161406 Comparator | Sep 2014 → Sep 2018 | diffuse cutaneous systemic sclerosis | Dinesh Khanna, MD, MS | Completed | No outcome recorded |
| Phase 2 | NCT02232880 Comparator | Aug 2014 → Jun 2015 | hypertensive disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02270957 Comparator | Jan 2014 → Dec 2018 | systemic lupus erythematosus | Oklahoma Medical Research Foundation | Completed | No outcome recorded |
| Phase 2 | NCT01917058 Comparator | Aug 2013 → Aug 2016 | alopecia areata | Columbia University | Withdrawn | No outcome recorded |
| Phase 2 | NCT01314495 Comparator | Sep 2011 → Jun 2012 | alopecia areata | Julian M. Mackay-Wiggan | Withdrawn | No outcome recorded |
| Phase 2 | NCT00534313 Comparator | Nov 2007 → Dec 2008 | psoriatic arthritis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2 | NCT00482066 Comparator | Nov 2007 → Nov 2008 | anti-neutrophil cytoplasmic antibody-associated vasculitis | Imperial College London | Terminated | No outcome recorded |
| Phase 2 | NCT00345748 Comparator | Jun 2006 → Nov 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00124449 Comparator | Feb 2005 → May 2007 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00035529 Comparator | Nov 2001 → Dec 2003 | multiple sclerosis | Bristol-Myers Squibb | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07366801 Comparator | Sep 2025 → Jun 2027 expected | acute lymphoblastic leukemia, acute myeloid leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Recruiting | No outcome recorded |
| Phase 2/3 | NCT01001832 Comparator | Dec 2009 → Feb 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT06654882 Comparator | Jan → Dec 2026 expected | polyarticular juvenile idiopathic arthritis | Duke University | Recruiting | No outcome recorded |
| Phase 3 | NCT04692493 Comparator | Sep 2021 → May 2029 expected | rheumatoid arthritis | University of Alabama at Birmingham | Recruiting | No outcome recorded |
| Phase 3 | NCT04593940 Comparator | Oct 2020 → Jan 2022 | COVID-19 | Daniel Benjamin | Completed | No outcome recorded |
| Phase 3 | NCT04000698 Background | Oct 2019 → Jul 2022 | acute lymphoblastic leukemia, acute myeloid leukemia | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 3 | NCT03086343 Comparator | May 2017 → Jun 2019 | rheumatoid arthritis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02971683 Comparator | May 2017 → Jul 2020 | dermatomyositis, immune-mediated necrotizing myopathy, juvenile idiopathic inflammatory myopathy, overlap myositis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT02778906 Comparator | Nov 2014 → Dec 2019 | arthritic joint disease | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase 3 | NCT02067910 Comparator | Aug 2014 → Feb 2019 | Sjogren syndrome | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 3 | NCT01350804 Comparator | Sep 2011 → Feb 2015 | rheumatoid arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01142726 Comparator | Dec 2010 → Sep 2013 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00929864 Comparator | Oct 2009 → Oct 2011 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00559585 Comparator | Jan 2008 → Nov 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 3 | NCT00420199 Comparator | May 2007 → Aug 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00989235 Comparator | Apr 2007 → Oct 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00122382 Comparator | Jul 2005 → Feb 2008 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00095147 Comparator | Feb 2005 → Jul 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00048581 Comparator | Dec 2002 → Sep 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00048932 Comparator | Dec 2002 → Oct 2009 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT03619876 Comparator | Jul 2019 → Sep 2021 | myocarditis, rheumatoid arthritis | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT03737708 Background | Feb 2019 → Jun 2020 | rheumatoid arthritis | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 4 | NCT02353780 Comparator | Mar 2015 → Dec 2017 | rheumatoid arthritis | Dr. Larry W. Moreland | Terminated | No outcome recorded |
| Phase 4 | NCT02466581 Comparator | Feb 2015 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01491815 Comparator | Dec 2012 → Jul 2023 | rheumatoid arthritis | Karolinska Institutet | Unknown | No outcome recorded |
| Phase 4 | NCT01557374 Comparator | Apr 2012 → Nov 2019 | rheumatoid arthritis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT01000441 Comparator | Dec 2009 → Aug 2013 | rheumatoid arthritis | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02547493 Comparator | Mar 2016 → Jan 2021 | rheumatoid arthritis | University Hospital, Montpellier | Completed | No outcome recorded |
| — | NCT02053727 Comparator | Jul 2014 → Jun 2018 | chronic hepatitis B virus infection, rheumatoid arthritis | University of California, Los Angeles | Withdrawn | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05170672 Background | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-06-06 | AbbVie | AbbVie Presents Data Showing RINVOQ™ (upadacitinib) Meets Primary and Key Secondary Endpoints in Phase 3 Head-to-Head Study Versus ORENCIA (abatacept) in Rheumatoid Arthritis Patients abbvie.com ↗ |
| 2012-06-06 | Bristol-Myers Squibb | ORENCIA® (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents bms.com ↗ |
| 2012-05-15 | Bristol-Myers Squibb | U.S. FDA Approves Bristol-Myers Squibb Devens Biologics Manufacturing Facility for Production of ORENCIA® (abatacept) bms.com ↗ |
| 2012-05-14 | Bristol-Myers Squibb | Bristol-Myers Squibb to Present New Data on ORENCIA® (abatacept) at the European League Against Rheumatism (EULAR) 2012 Congress bms.com ↗ |
| 2008-04-08 | Bristol-Myers Squibb | U.S. Food and Drug Administration Approves ORENCIA® (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older bms.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 205 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abatacept | “Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: \<60 kg Body weight (BW): 500 mg; \>60-100 kg BW: 750...” NCT01638715 ↗190“Switching to a non-TNFi-biologic (choice from non-TNFi-biologics; currently available are rituximab, abatacept, tocilizumab, or sarilumab) in people with active RA despite...” NCT04692493 ↗ “Abatacept (Orencia) is a selective T-cell modulator that blocks a co-stimulatory signal needed to activate T-cells and has an excellent safety profile.” NCT04261023 ↗ “330 subjects will be randomised 1:1:1 to receive a single 125 mg SC dose of abatacept administered as either DRL\_AB or RP or RMP.” NCT06126042 ↗ “The efficacy of abatacept, a selective costimulation modulator, in Crohn's disease (CD) and ulcerative colitis (UC) is unknown.” PMID 22504093 ↗ Apr 2012 “you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form.” NCT01717846 ↗ “Days +5, +14, +30, +60, +90: abatacept (IND) (10mg/kg/day IV)” NCT03128996 ↗ “Abatacept 10 mg/kg/day on the days +5, +14, +28, +60, +90” NCT06475820 ↗ “* Plerixafor GVHD prophylaxis * abatacept * tocilizumab” NCT04000698 ↗ “abatacept 10 mg/kg intravenous (IV) + methotrexate” NCT00122382 ↗ “Methotrexate or leflunomide + abatacept or” NCT02714634 ↗ “Abatacept: 125 mg s.c. every week.” NCT01491815 ↗ “Day -1: Abatacept 10mg/kg IV” NCT00920972 ↗ “Abatacept (Orencia®)” NCT02779114 ↗ “Drug: Abatacept” NCT00420199 ↗ |
| Known as | ABA | “OBJECTIVE: To determine whether higher serum exposure during subcutaneous (SC) abatacept (ABA) treatment was associated with an increased infection risk in adult patients with...” PMID 39814436 ↗ May 20253“We conducted a prospective randomized clinical trial to investigate the combination of posttransplant cyclophosphamide (PTCy) and abatacept (Aba) for graft-versus-host disease...” PMID 40554429 ↗ Aug 2025 “Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).” PMID 24584926 ↗ Mar 2014 “Abatacept (ABA) + Methotrexate (MTX), double-blind (DB)” NCT00095147 ↗ |
| Known as | Abatacept (genetical recombination) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201823 ↗ |
| Known as | Abatacept Injection | “Drug: Abatacept Injection” NCT04120831 ↗ |
| Known as | Abatacept recombinant | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201823 ↗ |
| Known as | BMS-188667 | “A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance...” NCT03714022 ↗6“Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate...” NCT00124982 ↗ “Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris” NCT00306878 ↗ “Abatacept (BMS-188667)” NCT00162266 ↗ “BMS 188667 (Abatacept)” NCT00035529 ↗ “BMS-188667 (Abatacept)” NCT00095173 ↗ |
| Known as | CTLA4-IgG4m | “RG2077 (CTLA4-IgG4m)” NCT00076934 ↗ |
| Known as | CTLA4Ig | “Abatacept, also known as CTLA4Ig, acts by blocking vital costimulatory signals required for T lymphocytes to be activated.” NCT00482066 ↗6“An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's).” PMID 24323392 ↗ Dec 2013 “Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris” NCT00306878 ↗ “abatacept also known as Orencia also known as CTLA4-Ig” NCT02429934 ↗ “Abatacept (CTLA4-Ig)” NCT05742243 ↗ |
| Known as | Dr. Reddy's Abatacept | “Other Name: Dr. Reddy's Abatacept” NCT06126042 ↗ |
| Known as | KSHB002 | “Test Product (A) (Kashiv's Abatacept): KSHB002 (Abatacept) Injection, 125 mg/mL - Manufactured by: Kashiv Bioscience's LLC, USA.” NCT06929039 ↗ |
| Known as | ORENCIA | “Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: \<60 kg Body weight (BW): 500 mg; \>60-100 kg BW: 750...” NCT01638715 ↗17“Orencia® (Abatacept) will be administered once a week for 6 months subcutaneously (injection under the skin) with an option to continue to receive Abatacept weekly injections...” NCT04203875 ↗ “The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment...” NCT02078882 ↗ “Reference Product (B) (US-licensed ORENCIA): 'ORENCIA' (abatacept) injection 125 mg/mL - Manufactured for: Bristol-Myers Squibb Company Princeton, NJ 08543 USA.” NCT06929039 ↗ “This study is being done to find out if a drug called Abatacept (Orencia ®) is safe and effective in treating people with chronic urticaria (persistent hives).” NCT00886795 ↗ “Abatacept (Orencia) is a selective T-cell modulator that blocks a co-stimulatory signal needed to activate T-cells and has an excellent safety profile.” NCT04261023 ↗ “Abatacept Injection [Orencia] and Proleukin (aldesleukin)” NCT06307301 ↗ “Patients will receive weekly abatacept (Orencia®) s.c.” NCT04106804 ↗ “Abatacept: Orencia 500-1000 mg/month and 125 mg/week” NCT01557374 ↗ “Orencia: Abatacept plus Methotrexate and steroids” NCT01491815 ↗ “Drug: Abatacept (Orencia)” NCT07238712 ↗ “Abatacept (Orencia®)” NCT02779114 ↗ “Other Names: Orencia” NCT06126042 ↗ “Abatacept (Orencia)” NCT00482066 ↗ “orencia” NCT01012492 ↗ |
| Known as | Orencia clickject | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201823 ↗ |
| Known as | RG-1046 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201823 ↗ |
| Known as | RG2077 | “Participants randomized to the CTLA4-IgG4m Arm will receive a single intravenous infusion of 10 mg/kg CTLA4-IgG4m (RG2077) following the scheduled cyclophosphamide infusion on...” NCT00094380 ↗ |
| Action | Inhibit | “to block the CD28/B7 T-cell costimulatory pathway” PMID 18794494 ↗ Sep 2008 |
| Modality | Protein / enzyme biologic | “RG2077 (CTLA4-IgG4m)” NCT00076934 ↗ |
| Route | Intravenous | “i.v infusion” NCT00035529 ↗ |
| Target | CD28 | “abatacept blocks the engagement of CD28 with its ligand” NCT03632187 ↗ |