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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Commercial
Therapeutic Areas
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 |
|---|---|---|---|---|---|
| Simponi | golimumab | Johnson & Johnson | N-125289 RX | 2009-04-24 | 4 products |
| Simponi Aria | golimumab | Johnson & Johnson | N-125433 RX | 2013-07-18 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| simponi | Biologic Licensing Application | 2023-11-21 |
| simponi aria | Biologic Licensing Application | 2023-07-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
golimumab, Simponi Aria, Janssen Biotech, Inc. | |||
| 2027-09-29 | Orphan excl. | ||
Patent Expiration
No data
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 |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | 5 | 24 | 9 | 27 | 66 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | 4 | 15 | 8 | 25 | 53 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 6 | 5 | 15 | 17 | 42 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 6 | 5 | 16 | 15 | 41 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 6 | 5 | 10 | 14 | 34 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | 9 | 10 | 13 | 33 |
| Spondylarthritis | D025241 | — | — | — | 1 | 9 | 10 | 12 | 32 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 2 | 1 | 8 | 2 | 10 | 23 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 1 | 6 | 5 | 8 | 20 |
| Axial spondyloarthritis | D000089183 | — | — | — | — | 4 | 4 | 2 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Juvenile arthritis | D001171 | EFO_1002007 | M08 | — | — | 2 | — | 1 | 3 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | 1 | — | 1 | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Necrosis | D009336 | — | — | — | 3 | — | — | 2 | 5 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 2 | — | — | 1 | 5 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 1 | — | — | 1 | 3 |
| Uveitis | D014605 | EFO_1001231 | H20.9 | — | 1 | — | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | — | — | — | 2 |
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | — | 1 | — | — | — | 1 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | 1 | — | — | — | 1 |
| Ear diseases | D004427 | EFO_1001455 | H93.9 | 1 | 1 | — | — | — | 1 |
| Labyrinth diseases | D007759 | — | — | 1 | 1 | — | — | — | 1 |
| Labyrinthitis | D007762 | — | H83.0 | 1 | 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 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 4 | 4 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 3 | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | — | — | 3 | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Symptom flare up | D000067251 | — | — | — | — | — | — | 2 | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | — | — | — | 2 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | — | 1 | 1 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | — | 1 | 1 |
| Fatigue | D005221 | — | R53.83 | — | — | — | — | 1 | 1 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Golimumab |
| INN | golimumab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| 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
| PDB | 5YOY |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201833 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06674 |
| UNII ID | 91X1KLU43E (ChemIDplus, GSRS) |
Target
Agency Approved
TNF
TNF
Organism
Homo sapiens
Gene name
TNF
Gene synonyms
TNFA, TNFSF2
NCBI Gene ID
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
Mouse ortholog
Tnf (21926)
tumor necrosis factor (P06804)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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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 8,096 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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70,380 adverse events reported
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