Palynziq(pegvaliase)
Palynziq (pegvaliase) is an enzyme pharmaceutical. Pegvaliase was first approved as Palynziq on 2018-05-24. It is used to treat phenylketonurias in the USA. It has been approved in Europe to treat phenylketonurias.
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Palynziq
Drug Products
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Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Pegvaliase
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Palynziq | pegvaliase-pqpz | BioMarin Pharmaceutical | N-761079 RX | 2018-05-24 | 3 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| palynziq | Biologic Licensing Application | 2022-12-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| phenylketonurias | — | D010661 | E70.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
pegvaliase, Palynziq, BioMarin Pharmaceutical Inc. | |||
| 2025-05-24 | Orphan excl. | ||
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Clinical
Clinical Trials
19 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Phenylketonurias | D010661 | — | E70.0 | 1 | 4 | 4 | 1 | 9 | 19 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Maternal phenylketonuria | D017042 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pegvaliase |
| INN | pegvaliase |
| Description | Pegvaliase, sold under the brand name Palynziq, is a medication for the treatment of the genetic disease phenylketonuria. Chemically, it is a pegylated derivative of the enzyme phenylalanine ammonia-lyase that metabolizes phenylalanine to reduce its blood levels.
|
| 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 | CHEMBL4297802 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12839 |
| UNII ID | N6UAH27EUV (ChemIDplus, GSRS) |
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Palynziq – BioMarin Pharmaceutical
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Additional graphs summarizing 338 documents
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Safety
Black-box Warning
Black-box warning for: Palynziq
Adverse Events
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7,193 adverse events reported
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