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Drug ReportsPegvaliase-pqpz
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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
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Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
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Brand Name
Status
Last Update
palynziqBiologic Licensing Application2022-12-21
Indications
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EMA
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Agency Specific
FDA
EMA
Expiration
Code
pegvaliase, Palynziq, BioMarin Pharmaceutical Inc.
2025-05-24Orphan excl.
Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A16: Other alimentary tract and metabolism products in atc
— A16A: Other alimentary tract and metabolism products in atc
— A16AB: Enzymes for alimentary tract and metabolism
— A16AB19: Pegvaliase
HCPCS
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Clinical
Clinical Trials
18 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
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Total
PhenylketonuriasD010661—E70.0144—918
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
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Maternal phenylketonuriaD017042——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePegvaliase
INNpegvaliase
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 classenzymes; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297802
ChEBI ID—
PubChem CID—
DrugBankDB12839
UNII IDN6UAH27EUV (ChemIDplus, GSRS)
Target
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Financial
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Palynziq – BioMarin Pharmaceutical
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 286 documents
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Safety
Black-box Warning
Black-box warning for: Palynziq
Adverse Events
Top Adverse Reactions
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5,686 adverse events reported
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