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AboutPricing
Drug ReportsAsfotase alfa
Strensiq(asfotase alfa)
Strensiq (asfotase alfa) is an enzyme pharmaceutical. Asfotase alfa was first approved as Strensiq on 2015-08-28. It is used to treat hypophosphatasia in the USA. It has been approved in Europe to treat hypophosphatasia.
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Variants
Financial
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Strensiq
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)
Asfotase alfa
Tradename
Proper name
Company
Number
Date
Products
Strensiqasfotase alfaAlexion PharmaceuticalsN-125513 RX2015-10-23
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
strensiqBiologic Licensing Application2024-07-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypophosphatasia—D007014E83.39
Agency Specific
FDA
EMA
Expiration
Code
asfotase alfa, Strensiq, Alexion Pharmaceuticals, Inc.
2122-10-23Orphan excl.
Patent Expiration
No data
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
— A16AB13: Asfotase alfa
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypophosphatasiaD007014—E83.392943420
Indications Phases 3
No data
Indications Phases 2
No data
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 nameAsfotase alfa
INNasfotase alfa
Description
Asfotase alfa, sold under the brand name Strensiq, is a medication used in the treatment of people with perinatal/infantile- and juvenile-onset hypophosphatasia.
Classification
Enzyme
Drug classenzymes
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108311
ChEBI ID—
PubChem CID—
DrugBankDB09105
UNII IDZ633861EIM (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Strensiq – Alexion Pharmaceuticals
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Strensiq – AstraZeneca
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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 442 documents
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Safety
Black-box Warning
Black-box warning for: Strensiq
Adverse Events
Top Adverse Reactions
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9,014 adverse events reported
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