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Sapropterin - Asubio-Pharma/BioMarin-Pharmaceutical/Daiichi-Sankyo-Company

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Drug Profile

Sapropterin - Asubio-Pharma/BioMarin-Pharmaceutical/Daiichi-Sankyo-Company

Alternative Names: 6R-BH4; BH4; Biopten; Dapropterin; Dapropterin dihydrochloride; Kuvan; Phenoptin; Sapropterin dihydrochloride; SUN-0588; SUN0588r; T-1401; Tetrahydrobiopterin; Tetrahydrobiopterin dihydrochloride

Latest Information Update: 05 Nov 2023

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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
  • No development reported Isolated systolic hypertension
  • Discontinued Coronary disorders; Hypertension; Kidney disorders; Peripheral arterial disorders; Pulmonary hypertension; Sickle cell anaemia; Vascular disorders

Most Recent Events

  • 28 Feb 2023 BioMarin Pharmaceutical has patents pending applications for Sapropterin in EU
  • 27 Dec 2022 NDR Batch #35: No updates and not done NDR for Isolated systolic hypertension line, as no info found for this indication on company website and trial also already terminated long back.
  • 31 Dec 2020 BioMarin Pharmaceutical has patent for Spropterin in USA and European union
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