Sapropterin
Various Alimentary Tract and Metabolism Products
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- Drug class
- Various Alimentary Tract and Metabolism Products
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 16
Overview
Sapropterin is an active pharmaceutical ingredient in the Various Alimentary Tract and Metabolism Products group (A16AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 13 | May 15, 2026 |
| EU European Union | EMA | 2 | May 18, 2026 |
| US United States | FDA | 1 | June 10, 2025 |
GBUnited Kingdom· MHRA
13 products
Uses
2). 2).
How to take
EUEuropean Union· EMA
2 products
Uses
2). 2).
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride tablets are a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. ( 1 )
Drug interactions
Known interactions involving Sapropterin. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL085530763 · revised January 10, 2025
- [2]European Medicines Agency · EMEA/H/C/005646 · revised May 18, 2026
- [3]FDA DailyMed · 11ee25bc-f501-4f… · revised June 10, 2025 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.