Abatacept
Highest phase reached
Approved
Drug type
Protein
First approval year
2006
- First approval year
- 2006
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Abatacept
- orencia
- Orencia
- orencia clickject
- Orencia clickject
- 1 25 oncostatin m human precursor fusion protein with ctla 4 antigen human fusion protein with immunoglobulin g1 human heavy chain fragment recombinant
- 1-25-ONCOSTATIN M (HUMAN PRECURSOR) FUSION PROTEIN WITH CTLA-4 (ANTIGEN) (HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (HUMAN HEAVY CHAIN FRAGMENT) (RECOMBINANT)
- abatacept
- Abatacept
- abatacept (ABA)
- Abatacept (BMS-188667)
- Abatacept (genetical recombination)
- ABATACEPT (GENETICAL RECOMBINATION) [JAN]
- abatacept (Orencia ®)
- Abatacept (Orencia)
- Abatacept (W12-W48)
- ABATACEPT [EMA EPAR]
- abatacept [INN]
- ABATACEPT [JAN]
- ABATACEPT [MART.]
- ABATACEPT [MI]
- ABATACEPT [PURPLE BOOK CDER]
- ABATACEPT [USAN]
- ABATACEPT [VANDF]
- Abatacept [WHO-DD]
- Abatacept 250 MG
- abatacept ema epar
- abatacept genetical recombination
- abatacept genetical recombination jan
- abatacept infusion
And 30 more, listed on the interactive page.
- ATC classification codes
- L04AA24
Sources for recorded values
- CAS registry numbers
- 332348-12-6
- ChEMBL ID
- CHEMBL1201823
- RxNorm IDs (RxCUI)
- 614391
- FDA ingredient codes (UNII)
- 7D0YB67S97
- Applicant
- BRISTOL MYERS SQUIBB
- Approval date
- 23 Dec 2005
- Application number
- BLA125118
- Status
- Authorised
- Status date
- 21 May 2007
- Authorisation date
- 21 May 2007
- Approved indications
- Rheumatoid arthritisOrencia, in combination with methotrexate, is indicated for: the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor. the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate. A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate. Psoriatic arthritis Orencia, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients when the response to previous DMARD therapy including MTX has been inadequate, and for whom additional systemic therapy for psoriatic skin lesions is not required. Polyarticular juvenile idiopathic arthritis Orencia in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 2 years of age and older who have had an inadequate response to previous DMARD therapy. Orencia can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
- Product number
- EMEA/H/C/000701
- Authorisation holder
- Bristol-Myers Squibb Pharma EEIG
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Arthritis, Juvenile Rheumatoid
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 15 Dec 2028
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- abatacept
- Type
- Peptide
- Drug name stem
- -cept
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CD80
- Gene symbol
- CD80
- Protein identifier
- P33681
- Median affinity
- 7.92
- Affinity units
- pKd
- Primary target
- Yes
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CD86
- Gene symbol
- CD86
- Protein identifier
- P42081
- Median affinity
- 7.92
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- T-lymphocyte activation antigen CD80 inhibitor
- Action type
- Inhibitor
- Target
- T-lymphocyte activation antigen CD80
- Protein identifier
- P33681
- Mechanism
- T-lymphocyte activation antigen CD86 inhibitor
- Action type
- Inhibitor
- Target
- T-lymphocyte activation antigen CD86
- Protein identifier
- P42081
- Mechanism
- T-lymphocyte activation antigen CD80 inhibitor
- Action type
- Inhibitor
- Target
- T-lymphocyte activation antigen CD80
- Mechanism
- T-lymphocyte activation antigen CD86 inhibitor
- Action type
- Inhibitor
- Target
- T-lymphocyte activation antigen CD86
- Condition
- Crohn Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Dermatomyositis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000398
- Subject identifier
- D003882
- Condition
- Scleroderma, Diffuse
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000404
- Subject identifier
- D045743
- Condition
- Hypertension
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Immune System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Psoriasis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Arthritis, Rheumatoid
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000685
- Subject identifier
- D001172
- Condition
- Sjogren's Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000699
- Subject identifier
- D012859
- Condition
- Scleroderma, Systemic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000717
- Subject identifier
- D012595
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Arthritis, Juvenile
- Highest recorded phase
- 4
- Condition identifier
- EFO:0002609
- Subject identifier
- D001171
- Condition
- Polymyositis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003063
- Subject identifier
- D017285
- Condition
- Arthritis, Psoriatic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003778
- Subject identifier
- D015535
- Condition
- Behcet Syndrome
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0003780
- Subject identifier
- D001528
- Condition
- Spondylitis, Ankylosing
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003898
- Subject identifier
- D013167
- Condition
- Multiple Sclerosis, Relapsing-Remitting
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003929
- Subject identifier
- D020529
- Condition
- Alopecia Areata
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004192
- Subject identifier
- D000506
- Condition
- Vitiligo
- Highest recorded phase
- 1
- Condition identifier
- EFO:0004208
- Subject identifier
- D014820
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Graft vs Host Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004599
- Subject identifier
- D006086
- Condition
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004826
- Subject identifier
- D056648
- Condition
- Myasthenia Gravis
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0004991
- Subject identifier
- D009157
- Condition
- Granulomatosis with Polyangiitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005297
- Subject identifier
- D014890
- Condition
- Lupus Nephritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
And 21 more, listed on the interactive page.
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000398
- Condition identifier
- EFO_0000404
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000537
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Condition identifier
- EFO_0000676
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000685
- Condition identifier
- EFO_0000699
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000729
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002609
- Condition identifier
- EFO_0003096
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003778
- Condition identifier
- EFO_0003780
- Condition identifier
- EFO_0003898
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003929
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004192
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004208
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004599
- Condition identifier
- EFO_0004826
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004991
- Condition identifier
- EFO_0005297
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005531
- Condition identifier
- EFO_0005676
- Highest recorded phase
- 1
- Condition identifier
- EFO_0005761
- Highest recorded phase
- 3
And 79 more, listed on the interactive page.
- Event
- abdominal discomfort
- Reports
- 3,374
- Reporting signal score
- 5,896.12
- Event
- alopecia
- Reports
- 3,538
- Reporting signal score
- 6,298.86
- Event
- anti-cyclic citrullinated peptide antibody positive
- Reports
- 1,124
- Reporting signal score
- 4,092.08
- Event
- apparent death
- Reports
- 196
- Reporting signal score
- 494.446
- Event
- arthralgia
- Reports
- 4,752
- Reporting signal score
- 5,099.67
- Event
- arthritis
- Reports
- 1,034
- Reporting signal score
- 1,263.47
- Event
- arthropathy
- Reports
- 3,782
- Reporting signal score
- 9,656.32
- Event
- blister
- Reports
- 774
- Reporting signal score
- 898.555
- Event
- blood cholesterol increased
- Reports
- 461
- Reporting signal score
- 448.154
- Event
- blood parathyroid hormone decreased
- Reports
- 202
- Reporting signal score
- 573.338
- Event
- bone erosion
- Reports
- 421
- Reporting signal score
- 1,282.76
- Event
- c-reactive protein abnormal
- Reports
- 1,081
- Reporting signal score
- 3,650.03
- Event
- c-reactive protein increased
- Reports
- 1,106
- Reporting signal score
- 1,649.63
- Event
- condition aggravated
- Reports
- 2,950
- Reporting signal score
- 2,468.82
- Event
- deformity
- Reports
- 284
- Reporting signal score
- 753.586
- Event
- disability
- Reports
- 416
- Reporting signal score
- 960.765
- Event
- discomfort
- Reports
- 1,288
- Reporting signal score
- 2,397.33
- Event
- diverticulitis
- Reports
- 505
- Reporting signal score
- 597.121
- Event
- drug hypersensitivity
- Reports
- 3,325
- Reporting signal score
- 2,996.51
- Event
- drug intolerance
- Reports
- 5,670
- Reporting signal score
- 12,581.4
- Event
- drug tolerance decreased
- Reports
- 233
- Reporting signal score
- 677.799
- Event
- duodenal ulcer perforation
- Reports
- 612
- Reporting signal score
- 1,976.82
- Event
- ear pain
- Reports
- 335
- Reporting signal score
- 450.646
- Event
- fatigue
- Reports
- 4,632
- Reporting signal score
- 2,525.64
- Event
- fibromyalgia
- Reports
- 464
- Reporting signal score
- 764.249
And 64 more, listed on the interactive page.
- NCT00035529
- NCT00076934
- NCT00048568
- NCT00048581
- NCT00048932
- NCT00095147
- NCT00122382
- NCT00124449
- NCT00124982
- NCT00162201
- NCT00162266
- NCT00162279
- NCT00254293
- NCT00279734
- NCT00279760
- NCT00345748
- NCT00409838
- NCT00420199
- NCT00484289
- NCT00533897
- NCT00547521
- NCT00559585
- NCT00663702
- NCT00767325
- NCT00929864
And 109 more, listed on the interactive page.
- Dose
- 500 mg
- Route
- Intravenous
- How often
- Every 4 weeks thereafter after initial doses at 0, 2, and 4 weeks
Conditions of use
- Administer as a 30-minute infusion
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Fusion Protein
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- MGVLLTQRTLLSLVLALLFPSMASMAMHVAQPAVVLASSRGIASFVCEYASPGKATEVRVTVLRQADSQVTEVCAATYMMGNELTFLDDSICTGTSSGNQVNLTIQGLRAMDTGLYICKVELMYPPPYYLGIGNGTQIYVIDPEPCPDSDQEPKSSDKTHTSPPSPAPELLGGSSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 0003-2187
- 0003-2188
- 0003-2814
- 0003-2818
Related records
Trials (206)
- A Clinical Trial to Evaluate the Efficacy of Abatacept in Moderate to Severe Alopecia Areata
- A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
- A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
- A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs
- A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
- A Phase III Study of Abatacept in Japanese Subjects With Rheumatoid Arthritis
- A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
- A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
- A Pilot Study of the Safety and Efficacy of Abatacept Injections in the Treatment of Behcet's Syndrome
- A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients With Rheumatoid Arthritis to a Specific Biologic Mode of Action
- A Rheumatoid Arthritis Study to Assess Early Response to Abatacept+MTX as Defined by Improvement of Synovitis Measures by Power Doppler Ultrasonography
- A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)
- A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate
- A Study of Abatacept in Patients With Active Crohn's Disease
- A Study of Abatacept in Patients With Active Ulcerative Colitis
- A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis
- A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
- A Study to Assess the Pharmacokinetics, Immunogenicity and Safety of Escalating Doses of BMS-188667 Given as a Single Intravenous Infusion to Patients With Psoriasis Vulgaris
- A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
Approved for (5)
- Immune system disorder
- Juvenile idiopathic arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Rheumatoid arthritis
In development for (41)
- Alopecia areata Phase 2
- Alopecia totalis Phase 2
- Amyotrophic lateral sclerosis Phase 1
- Ankylosing spondylitis Phase 2
- Anti-neutrophil antibody associated vasculitis Phase 3
- Autoimmune hepatitis Phase 1
- Behcet disease Early phase 1
- Chronic graft versus host disease Phase 1
- COVID-19 Phase 3
- Crohn disease Phase 3
- Dermatomyositis Phase 3
- Diffuse scleroderma Phase 2
- Graft versus host disease Phase 2
- Granulomatosis with polyangiitis Phase 3
- Hypertensive disorder Phase 2
- Immunoglobulin G4-related sclerosing disease Phase 2
- Lupus nephritis Phase 3
- Multiple sclerosis Phase 2
- Myasthenia gravis Early phase 1
- Myocarditis Phase 2