Cimzia(certolizumab pegol)
Cimzia (certolizumab pegol) is an antibody pharmaceutical. Certolizumab pegol was first approved as Cimzia on 2008-04-22. It is used to treat ankylosing spondylitis, crohn disease, psoriatic arthritis, and rheumatoid arthritis in the USA. It has been approved in Europe to treat rheumatoid arthritis. The pharmaceutical is active against tumor necrosis factor.
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Commercial
Trade Name
FDA
EMA
Cimzia
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)
Certolizumab pegol
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Cimzia | certolizumab pegol | UCB | N-125160 RX | 2008-04-22 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cimzia | Biologic Licensing Application | 2021-03-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| ankylosing spondylitis | EFO_0003898 | D013167 | M45 |
| crohn disease | EFO_0000384 | D003424 | K50 |
| psoriatic arthritis | EFO_0003778 | D015535 | L40.5 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0717 | Injection, certolizumab pegol, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered) |
Clinical
Clinical Trials
111 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 arthritis | D001172 | EFO_0000685 | M06.9 | 4 | 3 | 29 | 14 | 7 | 56 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 3 | 5 | 16 | 3 | 5 | 32 |
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 3 | — | 1 | 1 | 1 | 6 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | 2 | 1 | 1 | 1 | — | 5 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | 1 | — | 1 |
| Anterior uveitis | D014606 | EFO_1000811 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 3 | 5 | — | 2 | 10 |
| Interstitial cystitis | D018856 | EFO_1000869 | N30.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 1 | — | — | 1 | 2 |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | 1 | — | — | — | 1 |
| Pregnancy complications | D011248 | — | 1 | — | — | — | 1 | ||
| High-risk pregnancy | D018566 | — | 1 | — | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | — | 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 | ||
| Adenocarcinoma of lung | D000077192 | 1 | — | — | — | — | 1 | ||
| Melanoma | D008545 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy rate | D018873 | — | — | — | — | 2 | 2 | ||
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | 1 | 1 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CERTOLIZUMAB PEGOL |
| INN | certolizumab pegol |
| Description | Certolizumab pegol, sold under the brand name Cimzia, is a biologic medication for the treatment of Crohn's disease, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a fragment of a monoclonal antibody specific to tumor necrosis factor alpha (TNF-α) and is manufactured by UCB.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 428863-50-7 |
| RxCUI | 709271 |
| ChEMBL ID | CHEMBL1201831 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08904 |
| UNII ID | UMD07X179E (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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,268 documents
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Safety
Black-box Warning
Black-box warning for: Cimzia
Adverse Events
Top Adverse Reactions
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799 adverse events reported
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