Nulojix(belatacept)
Nulojix (belatacept) is a protein pharmaceutical. Belatacept was first approved as Nulojix on 2011-06-15. It has been approved in Europe to treat graft rejection and kidney transplantation. The pharmaceutical is active against T-lymphocyte activation antigen CD80 and T-lymphocyte activation antigen CD86.
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BMS
Commercial
Trade Name
FDA
EMA
Nulojix
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Belatacept
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Nulojix | belatacept | Bristol-Myers Squibb Company | N-125288 RX | 2011-06-15 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nulojix | Biologic Licensing Application | 2018-04-13 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
belatacept, Nulojix, Bristol-Myers Squibb Company | |||
| 2118-06-15 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0485 | Injection, belatacept, 1 mg |
Clinical
Clinical Trials
252 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 9 | 13 | 31 | 21 | 19 | 89 |
| Kidney transplantation | D016030 | 3 | 8 | 3 | 5 | 3 | 21 | ||
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | 1 | 3 | 1 | 1 | 7 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 1 | 2 | 1 | — | 4 |
| Dermatomyositis | D003882 | EFO_0000398 | M33 | 1 | 1 | 1 | 1 | — | 4 |
| Graft rejection | D006084 | — | 2 | — | 1 | — | 3 | ||
| Transplantation | D014180 | 1 | — | — | 1 | — | 2 | ||
| Epstein-barr virus infections | D020031 | EFO_0000769 | — | — | — | 1 | — | 1 | |
| Rheumatic diseases | D012216 | M79.0 | — | — | — | 1 | — | 1 | |
| Biliary liver cirrhosis | D008105 | K74.3 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | 6 | 1 | — | — | 6 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | 4 | — | — | 4 |
| Covid-19 | D000086382 | U07.1 | 1 | 2 | 1 | — | — | 3 | |
| Lupus nephritis | D008181 | EFO_0005761 | 1 | 1 | 1 | — | — | 3 | |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | 1 | 2 | — | — | 3 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | 2 | — | — | 3 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | 1 | 2 | 1 | — | — | 3 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | I77.82 | — | 2 | 1 | — | — | 3 | |
| Neoplasms | D009369 | C80 | — | 1 | 1 | — | — | 2 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 6 | — | — | 1 | 8 |
| Graft vs host disease | D006086 | D89.81 | 4 | 7 | — | — | — | 8 | |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 2 | — | — | — | 4 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | 3 | — | — | — | 3 |
| Immunosuppression therapy | D007165 | — | 1 | — | — | 1 | 2 | ||
| Heart transplantation | D016027 | EFO_0010673 | — | 2 | — | — | — | 2 | |
| Delayed graft function | D051799 | 1 | 1 | — | — | — | 2 | ||
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | 2 | — | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | 1 | 2 | — | — | — | 2 | |
| Alopecia areata | D000506 | EFO_0004192 | L63 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | 1 | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | — | — | — | — | 2 |
| Mucopolysaccharidosis i | D008059 | E76.0 | 1 | — | — | — | — | 1 | |
| Aplastic anemia | D000741 | HP_0001915 | D61.9 | 1 | — | — | — | — | 1 |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | 1 | — | — | — | — | 1 |
| Wiskott-aldrich syndrome | D014923 | D82.0 | 1 | — | — | — | — | 1 | |
| Hemophagocytic lymphohistiocytosis | D051359 | D76.1 | 1 | — | — | — | — | 1 | |
| Diamond-blackfan anemia | D029503 | D61.01 | 1 | — | — | — | — | 1 | |
| Shwachman-diamond syndrome | D000081003 | 1 | — | — | — | — | 1 |
Show 13 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Islets of langerhans transplantation | D016381 | — | — | — | — | 1 | 1 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | — | — | — | 1 | 1 |
| Gaucher disease | D005776 | Orphanet_355 | E75.22 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BELATACEPT |
| INN | belatacept |
| Description | Belatacept (immunoadhesin) |
| Classification | Protein |
| Drug class | receptor molecules or membrane ligands, natural, modified or modified: T-cell receptors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 706808-37-9 |
| RxCUI | 1112973 |
| ChEMBL ID | CHEMBL1742990 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06681 |
| UNII ID | E3B2GI648A (ChemIDplus, GSRS) |
Target
Agency Approved
CD80
CD80
CD86
CD86
Organism
Homo sapiens
Gene name
CD80
Gene synonyms
CD28LG, CD28LG1, LAB7
NCBI Gene ID
Protein name
T-lymphocyte activation antigen CD80
Protein synonyms
Activation B7-1 antigen, B-lymphocyte activation antigen B7, B7, BB1, CD80, CD80 antigen (CD28 antigen ligand 1, B7-1 antigen), costimulatory factor CD80, costimulatory molecule variant IgV-CD80, CTLA-4 counter-receptor B7.1
Uniprot ID
Mouse ortholog
Cd80 (12519)
T-lymphocyte activation antigen CD80 (Q61332)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nulojix - Bristol Myers Squibb
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,251 documents
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Safety
Black-box Warning
Black-box warning for: Nulojix
Adverse Events
Top Adverse Reactions
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720 adverse events reported
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