Chemical formula: C₉H₁₅N₅O₃ Molecular mass: 241.247 g/mol PubChem compound: 44257
Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan. The rationale for administration of sapropterin in patients with BH4-responsive PKU is to enhance the activity of the defective phenylalanine hydroxylase and thereby increase or restore the oxidative metabolism of phenylalanine. The rationale for administration of sapropterin in patients with BH4 Deficiency is to replace the deficient levels of BH4, thereby restoring the activity of phenylalanine hydroxylase.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| A16AX07 | Sapropterin | A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| KUVAN Soluble tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
Sapropterin is an active ingredient of these brands:
United States (US)
Australia (AU)
Austria (AT)
Brazil (BR)
Canada (CA)
Croatia (HR)
Ecuador (EC)
Estonia (EE)
Finland (FI)
France (FR)
Ireland (IE)
Israel (IL)
Italy (IT)
Japan (JP)
Lithuania (LT)
Netherlands (NL)
New Zealand (NZ)
Poland (PL)
Romania (RO)
Spain (ES)
Turkey (TR)United Kingdom (UK)
Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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