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Simponi(golimumab)
Simponi (golimumab) is an antibody pharmaceutical. Golimumab was first approved as Simponi on 2009-04-24. It is used to treat rheumatoid arthritis in the USA. It has been approved in Europe to treat ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. The pharmaceutical is active against tumor necrosis factor.
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Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Simponi, Simponi aria
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)
Golimumab
Tradename
Proper name
Company
Number
Date
Products
SimponigolimumabJohnson & JohnsonN-125289 RX2009-04-24
4 products
Simponi AriagolimumabJohnson & JohnsonN-125433 RX2013-07-18
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
simponiBiologic Licensing Application2023-04-11
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
rheumatoid arthritisEFO_0000685D001172M06.9
Agency Specific
FDA
EMA
Expiration
Code
golimumab, Simponi Aria, Janssen Biotech, Inc.
2027-09-29Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AB: Tumor necrosis factor alpha (tnf-alpha) inhibitors
— L04AB06: Golimumab
HCPCS
Code
Description
J1602
Injection, golimumab, 1 mg, for intravenous use
Clinical
Clinical Trials
108 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_0000685M06.913123928
Ulcerative colitisD003093EFO_0000729K5116511526
Psoriatic arthritisD015535EFO_0003778L40.52181416
Ankylosing spondylitisD013167EFO_0003898M45——45312
SpondylarthritisD025241———112
Crohn diseaseD003424EFO_0000384K50—1—1—2
Inflammatory bowel diseasesD015212EFO_0003767———112
ColitisD003092EFO_0003872K52.9———1—1
SpondylarthropathiesD025242EFO_0000706M47———1—1
ThromboembolismD013923HP_0001907———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Juvenile arthritisD001171EFO_0002609M08——2——2
ArthritisD001168EFO_0005856M05-M14——1——1
Autoimmune diseasesD001327EFO_0000540M30-M36——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E1012——14
AsthmaD001249EFO_0000270J45—2———2
SarcoidosisD012507EFO_0000690D80-D89—1———1
Behcet syndromeD001528EFO_0003780M35.2—1———1
UveitisD014605EFO_1001231H20.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2————2
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Symptom flare upD000067251————22
Major depressive disorderD003865EFO_0003761F22————22
InfectionsD007239EFO_0000544————11
PsoriasisD011565EFO_0000676L40————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGOLIMUMAB
INNgolimumab
Description
Immunoglobulin G1, anti-(human tumor necrosis factor a) (human monoclonal CNTO 148 gamma1-chain), disulfide with human monoclonal CNTO 148 kappa-chain, dimer
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)GOLIMUMAB
Structure (InChI/SMILES or Protein Sequence)
>5YOY:D,E,F,M,N,O|Golimumab light chain variable region AGSEIVLTQSPATLSLSPGERATLSCRASQSVYSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISS LEPEDFAVYYCQQRSNWPPFTFGPGTKVDIKTSENLYFQ >5YOY:G,H,I,P,Q,R|Golimumab heavy chain variable region SKLQVQLVESGGGVVQPGRSLRLSCAASGFIFSSYAMHWVRQAPGNGLEWVAFMSYDGSNKKYADSVKGRFTISRDNSKN TLYLQMNSLRAEDTAVYYCARDRGIAAGGNYYYYGMDVWGQGTTVTVSS
Identifiers
PDB5YOY
CAS-ID476181-74-5
RxCUI819300
ChEMBL IDCHEMBL1201833
ChEBI ID—
PubChem CID—
DrugBankDB06674
UNII ID91X1KLU43E (ChemIDplus, GSRS)
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
7124
Protein name
tumor necrosis factor
Protein synonyms
APC1 protein, Cachectin, TNF, macrophage-derived, TNF, monocyte-derived, TNF-a, TNF-alpha, tumor necrosis factor ligand 1F, Tumor necrosis factor ligand superfamily member 2, tumor necrosis factor-alpha, tumor necrotic factor alpha
Uniprot ID
Q9UIV3
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Simponi - Johnson & Johnson
$
€
£
₣
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Simponi - Merck Sharp & Dohme
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,478 documents
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Safety
Black-box Warning
Black-box warning for: Simponi
Adverse Events
Top Adverse Reactions
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7,223 adverse events reported
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