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Drug ReportsGolimumab
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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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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 Application2023-11-21
simponi ariaBiologic Licensing Application2025-02-07
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
166 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K511541312
ArthritisD001168EFO_0005856M05-M14—161311
ColitisD003092EFO_0003872K52.91541211
UlcerD014456MPATH_579—1541110
Psoriatic arthritisD015535EFO_0003778L40.5—13127
SpondylitisD013166—M46.9——4127
SpondylarthritisD025241————4116
Ankylosing spondylitisD013167EFO_0003898M45——2125
Crohn diseaseD003424EFO_0000384K50—1—1—2
LymphomaD008223—C85.9———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.9——2—35
Axial spondyloarthritisD000089183————3——3
Juvenile arthritisD001171EFO_1002007M08——2——2
Autoimmune diseasesD001327EFO_0000540M30-M36——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E1311——13
Type 1 diabetes mellitusD003922EFO_0001359E1011——13
Prostatic neoplasmsD011471—C61—1———1
Castration-resistant prostatic neoplasmsD064129———1———1
AdenocarcinomaD000230———1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alzheimer diseaseD000544EFO_0000249F03————11
DementiaD003704EFO_0003862F03————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)Loading
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-ID—
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Simponi – Johnson & Johnson
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Simponi – Merck & Co
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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 8,210 documents
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Safety
Black-box Warning
Black-box warning for: Simponi, Simponi aria
Adverse Events
Top Adverse Reactions
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72,888 adverse events reported
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