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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5Y
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FDA approval date
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Patent expiration date
Study first post date
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Start date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| skin and connective tissue diseases | D017437 |
| immune system diseases | D007154 |
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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| benlysta | Biologic Licensing Application | 2025-06-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| systemic lupus erythematosus | EFO_0002690 | D008180 | M32 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0490 | Injection, belimumab, 10 mg |
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 7 | 5 | 10 | 8 | 7 | 37 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | 2 | 1 | 1 | 4 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | 2 | 2 | — | — | 3 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 1 | 3 | — | — | 3 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | 1 | — | 1 | 2 |
| Nephritis | D009393 | — | N05 | — | — | 1 | — | 1 | 2 |
| Sclerosis | D012598 | — | — | — | 1 | 1 | — | — | 2 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | 1 | 1 | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | — | 1 | 2 | — | — | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 2 | — | — | 2 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | 1 | 1 | — | — | 1 |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | — | 1 | — | — | 1 |
Show 4 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 3 | — | — | — | 3 |
| Kidney transplantation | D016030 | — | — | 1 | 2 | — | — | — | 2 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | — | — | 1 | 2 |
| Glomerulonephritis | D005921 | — | N05 | — | 2 | — | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 1 | — | — | — | 1 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 1 | — | — | — | 1 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | — | I77.82 | — | 1 | — | — | — | 1 |
| Nephrotic syndrome | D009404 | EFO_0004255 | N04 | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
Show 13 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | D89.811 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Discoid lupus erythematosus | D008179 | — | L93.0 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Belimumab |
| INN | belimumab |
| Description | Belimumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >5Y9K:H|belimumab heavy chain
QVQLQQSGAEVKKPGSSVRVSCKASGGTFNNNAINWVRQAPGQGLEWMGGIIPMFGTAKYSQNFQGRVAITADESTGTAS
MELSSLRSEDTAVYYCARSRDLLLFPHHALSPWGRGTMVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPV
TVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH
>5Y9K:L|belimumab light chain
SSELTQDPAVSVALGQTVRVTCQGDSLRSYYASWYQQKPGQAPVLVIYGKNNRPSGIPDRFSGSSSGNTASLTITGAQAE
DEADYYCSSRDSSGNHWVFGGGTELTVLGQPKAAPSVTLFPPSSEELQANKATLVCLISDFYPGAVTVAWKADSSPVKAG
VETTTPSKQSNNKYAASSYLSLTPEQWKSHRSYSCQVTHEGSTVEKTVAPTECS |
Identifiers
| PDB | 5Y9J, 5Y9K, 6FXN |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1789843 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08879 |
| UNII ID | 73B0K5S26A (ChemIDplus, GSRS) |
Target
Agency Approved
TNFSF13B
TNFSF13B
Organism
Homo sapiens
Gene name
TNFSF13B
Gene synonyms
BAFF, BLYS, TALL1, TNFSF20, ZTNF4
NCBI Gene ID
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
Mouse ortholog
Tnfsf13b (24099)
tumor necrosis factor ligand superfamily member 13B (Q9WU72)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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28,065 adverse events reported
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