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
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 |
|---|---|---|---|---|---|
| Krystexxa | pegloticase | Horizon Therapeutics Public | N-125293 RX | 2010-09-14 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| krystexxa | Biologic Licensing Application | 2025-08-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gout | EFO_0004274 | D006073 | M10 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
pegloticase, Krystexxa, Horizon Therapeutics Ireland DAC | |||
| 2117-09-14 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2507 | Injection, pegloticase, 1 mg |
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gout | D006073 | EFO_0004274 | M10 | 1 | 6 | 3 | 7 | 1 | 18 |
| Hematologic neoplasms | D019337 | — | — | — | — | — | 1 | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
| Tumor lysis syndrome | D015275 | — | E88.3 | — | — | — | 1 | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperuricemia | D033461 | — | — | 1 | 2 | 1 | — | — | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 2 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
| Diabetes complications | D048909 | — | — | — | 1 | — | — | — | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
| Gouty arthritis | D015210 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Asymptomatic diseases | D058070 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegloticase |
| INN | pegloticase |
| 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 class | enzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1237025 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09208 |
| UNII ID | R581OT55EA (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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Krystexxa – Horizon Therapeutics Public
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Krystexxa – Amgen
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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 778 documents
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Safety
Black-box Warning
Black-box warning for: Krystexxa
Adverse Events
Top Adverse Reactions
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3,329 adverse events reported
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