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Benlysta(belimumab)
Benlysta (belimumab) is an antibody pharmaceutical. Belimumab was first approved as Benlysta on 2011-03-09. It is used to treat systemic lupus erythematosus in the USA. It has been approved in Europe to treat systemic lupus erythematosus. The pharmaceutical is active against tumor necrosis factor ligand superfamily member 13B.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Benlysta
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)
Belimumab
Tradename
Proper name
Company
Number
Date
Products
BenlystabelimumabGSKN-125370 RX2011-03-09
2 products
BenlystabelimumabGSKN-761043 RX2017-07-20
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
benlystaBiologic Licensing Application2021-03-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
systemic lupus erythematosusEFO_0002690D008180M32
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AA: Selective immunosuppressants
— L04AA26: Belimumab
HCPCS
Code
Description
J0490
Injection, belimumab, 10 mg
Clinical
Clinical Trials
83 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Systemic lupus erythematosusD008180EFO_0002690M32671110741
Immunoglobulin g4-related diseaseD000077733———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lupus nephritisD008181EFO_0005761—11—13
Thrombocytopenic purpura idiopathicD016553EFO_0007160D69.3—11—13
VasculitisD014657EFO_0006803M31—11——2
MyositisD009220EFO_0000783G72.49—11——1
Antiphospholipid syndromeD016736EFO_0002689D68.61—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.9—2——24
Membranous glomerulonephritisD015433EFO_0004254N03.2—3———3
Systemic sclerodermaD012595EFO_0000717M34—2———2
Sjogren's syndromeD012859EFO_0000699M35.0—2———2
Graft vs host diseaseD006086D89.8121———2
Kidney transplantationD016030—1———1
Multiple sclerosisD009103EFO_0003885G35—1———1
CryoglobulinemiaD003449EFO_0005846D89.1—1———1
Granulomatosis with polyangiitisD014890EFO_0005297M31.3—1———1
Anti-neutrophil cytoplasmic antibody-associated vasculitisD056648I77.82—1———1
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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—2————2
Idiopathic cd4-positive t-lymphocytopeniaD018344EFO_00073221————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Discoid lupus erythematosusD008179L93.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBELIMUMAB
INNbelimumab
Description
Belimumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)BELIMUMAB
Structure (InChI/SMILES or Protein Sequence)
>5Y9K:H|belimumab heavy chain QVQLQQSGAEVKKPGSSVRVSCKASGGTFNNNAINWVRQAPGQGLEWMGGIIPMFGTAKYSQNFQGRVAITADESTGTAS MELSSLRSEDTAVYYCARSRDLLLFPHHALSPWGRGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPV TVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH >5Y9K:L|belimumab light chain SSELTQDPAVSVALGQTVRVTCQGDSLRSYYASWYQQKPGQAPVLVIYGKNNRPSGIPDRFSGSSSGNTASLTITGAQAE DEADYYCSSRDSSGNHWVFGGGTELTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAG VETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS
Identifiers
PDB5Y9J, 5Y9K, 6FXN
CAS-ID356547-88-1
RxCUI1092437
ChEMBL IDCHEMBL1789843
ChEBI ID—
PubChem CID—
DrugBankDB08879
UNII ID73B0K5S26A (ChemIDplus, GSRS)
Target
Agency Approved
TNFSF13B
TNFSF13B
Organism
Homo sapiens
Gene name
TNFSF13B
Gene synonyms
BAFF, BLYS, TALL1, TNFSF20, ZTNF4
NCBI Gene ID
10673
Protein name
tumor necrosis factor ligand superfamily member 13B
Protein synonyms
ApoL related ligand TALL-1, B lymphocyte stimulator, B-cell-activating factor, B-lymphocyte stimulator, BAFF, BLyS, CD257, delta BAFF, Delta4 BAFF, Dendritic cell-derived TNF-like molecule, epididymis secretory sperm binding protein, TALL-1, TNF and ApoL-related leukocyte expressed ligand 1, TNF homolog that activates apoptosis, TNF- and APOL-related leukocyte expressed ligand 1, tumor necrosis factor (ligand) superfamily, member 13b, tumor necrosis factor (ligand) superfamily, member 20, tumor necrosis factor ligand 7A, tumor necrosis factor superfamily member 13b, tumor necrosis factor-like protein ZTNF4
Uniprot ID
Q9Y275
Mouse ortholog
Tnfsf13b (24099)
tumor necrosis factor ligand superfamily member 13B (Q9WU72)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,271 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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2,391 adverse events reported
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