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JZP 258

Drug Profile

JZP 258

Alternative Names: JZP-258; Oxybate mixed salt solution – Jazz Pharmaceuticals; Xywav

Latest Information Update: 02 Jun 2021

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At a glance

  • Originator Jazz Pharmaceuticals plc
  • Class Hydroxybutyrates; Sleep disorder therapies; Small molecules
  • Mechanism of Action Dopamine receptor agonists
  • Orphan Drug Status

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

    Yes - Hypersomnia
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cataplexy; Narcolepsy
  • Preregistration Hypersomnia

Most Recent Events

  • 09 May 2021 Planned Prescription Drug User Fee Act (PDUFA) date for Hypersomnia in USA (PO) is 2021-08-12
  • 20 Apr 2021 Adverse events and efficacy data from a phase III trial in Hypersomnia released by Jazz Pharmaceuticals
  • 20 Apr 2021 JZP 258 receives priority review status for Hypersomnia in US
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