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Sapropterin - Asubio Pharma/BioMarin Pharmaceutical

Drug Profile

Sapropterin - Asubio Pharma/BioMarin Pharmaceutical

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

Latest Information Update: 03 Jul 2019

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At a glance

  • Originator Asubio Pharma; Daiichi Sankyo Company
  • Developer Asubio Pharma; BioMarin Pharmaceutical; Daiichi Sankyo Company; John Hopkins University
  • Class Antianaemics; Antihypertensives; Anxiolytics; Nootropics; Pterins; Small molecules; Urologics; Vascular disorder therapies
  • 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
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 26 Jun 2019 Biomarin Pharmaceuticals completes a phase III extension trial for Phenylketonuria (PO) in Germany, Ireland, Italy and United Kingdom (EudraCT2004-004513-41)
  • 01 Dec 2018 BioMarin Pharmaceutical completes the phase II RIDD-HF trial for Hypertension (in heart failure patients) in USA (PO) (NCT02353312)
  • 24 Jun 2018 Biomarkers information updated
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