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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Commercial
Therapeutic Areas
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 | N-125288 RX | 2011-06-15 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nulojix | Biologic Licensing Application | 2021-07-28 |
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
336 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 10 | 14 | 29 | 9 | 36 | 93 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 9 | 12 | 26 | 9 | 33 | 85 |
| Kidney transplantation | D016030 | — | — | 2 | 8 | 3 | 3 | 7 | 22 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | 1 | 1 | 1 | 3 | 6 |
| Graft rejection | D006084 | — | — | — | 3 | — | 1 | — | 4 |
| Delayed graft function | D051799 | — | — | 1 | 1 | — | 1 | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | 1 | 1 | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | — | 1 | 1 | 1 | — | 3 |
| Transplantation | D014180 | — | — | 1 | — | — | 1 | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | 1 | 1 | — | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 4 | 1 | — | — | 6 |
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 3 | — | 2 | 5 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | 5 | 1 | — | — | 5 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 3 | 2 | — | — | 5 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 1 | — | 1 | — | — | 2 |
| Nephritis | D009393 | — | N05 | 1 | — | 1 | — | — | 2 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | — | 2 | — | — | 2 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | — | — | 2 | — | — | 2 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | 1 | — | — | 2 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | 1 | 1 | — | — | 2 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Organ transplantation | D016377 | — | — | — | 2 | — | — | 1 | 3 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | 2 | — | — | — | 3 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 3 | — | — | — | 3 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 3 | — | — | — | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | 1 | — | — | — | 3 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 2 | — | — | — | 2 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | 2 | — | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | 2 | — | — | — | 2 |
| Sclerosis | D012598 | — | — | — | 2 | — | — | — | 2 |
| Heart transplantation | D016027 | EFO_0010673 | — | — | 1 | — | — | — | 1 |
Show 26 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | 1 | — | — | — | — | 1 |
| Muscle weakness | D018908 | — | — | 1 | — | — | — | — | 1 |
| Vitiligo | D014820 | EFO_0004208 | L80 | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | — | — | — | — | 1 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | 1 | — | — | — | — | 1 |
| Relapsing polychondritis | D011081 | EFO_1001148 | M94.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Islets of langerhans transplantation | D016381 | — | — | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Stem cell transplantation | D033581 | — | — | — | — | — | — | 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 | — |
| RxCUI | — |
| 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
No data
Financial
Revenue by drug
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Nulojix – Bristol Myers Squibb
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Trends
PubMed Central
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Additional graphs summarizing 2,900 documents
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Safety
Black-box Warning
Black-box warning for: Nulojix
Adverse Events
Top Adverse Reactions
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3,863 adverse events reported
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