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Drug ReportsCertolizumab pegol
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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Clinical
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Target
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Safety
Events Timeline
5D
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3M
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YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
Patent expiration date
Study 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
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
Cimziacertolizumab pegolUCBN-125160 RX2008-04-22
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
cimziaBiologic Licensing Application2024-09-19
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AB: Tumor necrosis factor alpha (tnf-alpha) inhibitors
L04AB05: Certolizumab pegol
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
167 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ArthritisD001168EFO_0005856M05-M14422271045
Rheumatoid arthritisD001172EFO_0000685M06.942207942
Crohn diseaseD003424EFO_0000384K5034173835
SpondylitisD013166M46.93151313
SpondylarthritisD0252413151212
Axial spondyloarthritisD00008918333129
Human influenzaD007251EFO_0007328J11.111
UveitisD014605EFO_1001231H20.911
Anterior uveitisD014606EFO_100081111
IridocyclitisD015863H2011
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ulcerative colitisD003093EFO_0000729K5111
ColitisD003092EFO_0003872K52.911
UlcerD014456MPATH_57911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients33
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Autoimmune diseasesD001327EFO_0000540M30-M3611
AbscessD000038EFO_000303011
Rheumatic diseasesD012216M79.011
Collagen diseasesD00309511
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCertolizumab pegol
INNcertolizumab 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 classmonoclonal antibodies; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID
RxCUI
ChEMBL IDCHEMBL1201831
ChEBI ID
PubChem CID
DrugBankDB08904
UNII IDG6ADW90R16 (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
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,312 documents
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Safety
Black-box Warning
Black-box warning for: Cimzia
Adverse Events
Top Adverse Reactions
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108,867 adverse events reported
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