PRX OTC

Drug Profile

PRX OTC

Alternative Names: PRX-OTC

Latest Information Update: 26 Apr 2017

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At a glance

  • Originator PhaseRx
  • Class Enzymes
  • Mechanism of Action Enzyme replacements
  • Orphan Drug Status

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

    Yes - Inborn urea cycle disorders
  • New Molecular Entity Yes

Highest Development Phases

  • Preclinical Inborn urea cycle disorders

Most Recent Events

  • 25 Apr 2017 The European Medicines Agency's Committee for Orphan Medicinal Products issues a positive opinion recommending Orphan Drug status for PRX OTC for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) in European Union
  • 28 Nov 2016 PRX OTC receives Orphan Drug status for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) in USA
  • 28 Nov 2016 PhaseRx plans to file an IND application with the US FDA in USA for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) by the end of 2017
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