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Krystexxa(pegloticase)
Krystexxa (pegloticase) is an enzyme pharmaceutical. Pegloticase was first approved as Krystexxa on 2010-09-14. It is used to treat gout in the USA. It has been approved in Europe to treat gout.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Krystexxa
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)
Pegloticase
Tradename
Proper name
Company
Number
Date
Products
KrystexxapegloticaseHorizon Therapeutics PublicN-125293 RX2010-09-14
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
krystexxaBiologic Licensing Application2020-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
goutEFO_0004274D006073M10
Agency Specific
FDA
EMA
Expiration
Code
pegloticase, Krystexxa, Horizon Therapeutics Ireland DAC
2117-09-14Orphan excl.
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M04: Antigout preparations
— M04A: Antigout preparations
— M04AX: Other antigout preparations in atc
— M04AX02: Pegloticase
HCPCS
Code
Description
J2507
Injection, pegloticase, 1 mg
Clinical
Clinical Trials
6 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Severe combined immunodeficiencyD016511D81.0441——5
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Immunologic deficiency syndromesD007153HP_0002721D84.9—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePEGLOTICASE
INNpegloticase
Description
Tetramer alpha4 of des-(1-5)-[6-threonine,45-threonine,290-lysine,300-serine]uricase (EC 1.7.3.3, urate oxidase) from Sus scrofa (porcine), non acetylated, of which some of the lysine 6-amine residues are engaged in a carbamate linkage with a monomethylic ether of polyoxyethylene (macrogol)
Classification
Enzyme
Drug classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID885051-90-1
RxCUI1011650
ChEMBL IDCHEMBL1237025
ChEBI ID—
PubChem CID—
DrugBankDB09208
UNII IDR581OT55EA (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Krystexxa - Horizon Therapeutics Public
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 555 documents
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Safety
Black-box Warning
Black-box warning for: Krystexxa
Adverse Events
Top Adverse Reactions
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152 adverse events reported
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