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Phase 3
Development Phase
0
Upcoming Catalysts
0
Historical Events
1
Regulatory Approvals
No Catalysts Found
No catalyst events have been recorded for this drug yet.
Competitive Landscape
0 competitors in Phenylketonurias
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Patent & Exclusivity
No patent data available. Pre-approval drugs may not have Orange Book listings.
Regulatory Approvals
EMA2/16/2022
Sapropterin Dipharma
Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
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Mechanism of action & safety profile
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