Drug Profile


Alternative Names: 6R-BH4; 6R-tetrahydrobiopterin; BH4; Biopten; Kuvan; Phenoptin; Sapropterin dihydrochloride; SUN-0588; SUN0588r

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Asubio Pharma; Daiichi Sankyo Company
  • Developer Asubio Pharma; BioMarin Pharmaceutical; Daiichi Sankyo Company; Merck Serono
  • Class Anxiolytics; Nootropics; Pterins; Small molecules
  • Mechanism of Action Nitric oxide synthase stimulants; Phenylalanine hydroxylase stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Phenylketonuria
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Phenylketonuria
  • Discontinued Coronary disorders; Hypertension; Kidney disorders; Peripheral arterial disorders; Pulmonary hypertension; Sickle cell anaemia; Vascular disorders

Most Recent Events

  • 01 Oct 2015 Sapropterin licensed to BioMarin worldwide (except Japan)
  • 22 May 2015 CHMP recommends approval of sapropterin for Phenylketonuria (In children, In infants, In neonates) in European Union, Iceland, Liechtenstein and Norway
  • 22 May 2015 Efficacy data from the phase III SPARK study in Phenylketonuria (In children, In infants, In neonates) released by Merck Serono
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