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Drug ReportsBelatacept
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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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
therapeuticsD013812
operative surgical proceduresD013514
immune system phenomenaD055633
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
NulojixbelataceptBristol Myers SquibbN-125288 RX2011-06-15
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
nulojixBiologic Licensing Application2021-07-28
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
belatacept, Nulojix, Bristol-Myers Squibb Company
2118-06-15Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA28: Belatacept
HCPCS
Code
Description
J0485
Injection, belatacept, 1 mg
Clinical
Clinical Trials
341 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 arthritisD001172EFO_0000685M06.91215332355133
ArthritisD001168EFO_0005856M05-M14241273861
Kidney transplantationD016030——616361140
Graft rejectionD006084———614111
Psoriatic arthritisD015535EFO_0003778L40.5—122510
Chronic kidney failureD007676EFO_0003884N18.6213117
Covid-19D000086382—U07.1121115
Delayed graft functionD051799——11—215
Immunosuppression therapyD007165———1—124
Psychology rejectionD012059———2—114
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Juvenile arthritisD001171EFO_1002007M08116—29
Myelodysplastic syndromesD009190—D46163——7
Renal insufficiencyD051437—N192—3—16
LeukemiaD007938—C95153——6
Systemic lupus erythematosusD008180EFO_0002690M32161——6
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.0—44——6
Sjogren's syndromeD012859EFO_0000699M35.0—32——5
LymphomaD008223—C85.9—43——5
Biphenotypic leukemia acuteD015456—C95.0—33——4
Myeloid leukemia acuteD015470—C92.0—32——4
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Graft vs host diseaseD006086—D89.8189———12
Type 1 diabetes mellitusD003922EFO_0001359E1027——210
PsoriasisD011565EFO_0000676L4022——15
Sickle cell anemiaD000755EFO_0000697D5742———4
InflammationD007249MP_0001845—12——14
Interstitial lung diseasesD017563EFO_0004244J84.9—3——14
Coronavirus infectionsD018352EFO_0007224B34.212——13
Heart transplantationD016027EFO_0010673——3———3
Organ transplantationD016377———2——13
Alopecia areataD000506EFO_0004192L63—3———3
Show 58 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
Cardiovascular diseasesD002318EFO_0000319I981———23
Islets of langerhans transplantationD016381——1———12
Mucopolysaccharidosis iD008059—E76.01————1
Beta-thalassemiaD017086Orphanet_848D56.11————1
Wiskott-aldrich syndromeD014923EFO_0003903D82.01————1
Hemophagocytic lymphohistiocytosisD051359—D76.11————1
Diamond-blackfan anemiaD029503EFO_0004130D61.011————1
Shwachman-diamond syndromeD000081003—D61.021————1
Fanconi anemiaD005199Orphanet_84D61.031————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—————22
Hepatitis bD006509——————22
HemorrhageD006470MP_0001914R58————11
Heart failureD006333EFO_0003144I50————11
MenorrhagiaD008595EFO_0003945N92.0————11
Hemophilia aD006467EFO_0007267D66————11
PainD010146EFO_0003843R52————11
Down syndromeD004314EFO_0001064Q90————11
PneumoniaD011014EFO_0003106J18————11
Blood coagulation disordersD001778EFO_0009314D68.9————11
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBelatacept
INNbelatacept
Description
Belatacept (immunoadhesin)
Classification
Protein
Drug classreceptor molecules or membrane ligands, natural, modified or modified: T-cell receptors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL1742990
ChEBI ID—
PubChem CID—
DrugBankDB06681
UNII IDE3B2GI648A (ChemIDplus, GSRS)
Target
Agency Approved
CD86
CD86
Organism
Homo sapiens
Gene name
CD86
Gene synonyms
CD28LG2
NCBI Gene ID
Protein name
T-lymphocyte activation antigen CD86
Protein synonyms
Activation B7-2 antigen, B-lymphocyte activation antigen B7-2, B70, BU63, CD86, CD86 antigen (CD28 antigen ligand 2, B7-2 antigen), CTLA-4 counter-receptor B7.2, FUN-1
Uniprot ID
Mouse ortholog
Cd86 (12524)
T-lymphocyte activation antigen CD86 (P42082)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Nulojix – Bristol Myers Squibb
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,070 documents
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Safety
Black-box Warning
Black-box warning for: Nulojix
Adverse Events
Top Adverse Reactions
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4,201 adverse events reported
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