Sodium oxybate

Drug Profile

Sodium oxybate

Alternative Names: Gamma-hydroxybutyrate; JZP-6; KEY-10; NSC-84223; Xyrem

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Jazz Pharmaceuticals
  • Developer Jazz Pharmaceuticals; Jazz Pharmaceuticals Inc; Jazz Pharmaceuticals plc; UCB; Valeant Pharmaceuticals International
  • 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 - Cataplexy; Narcolepsy
  • 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 No

Highest Development Phases

  • Marketed Cataplexy; Narcolepsy
  • Discontinued Essential tremor; Fibromyalgia

Most Recent Events

  • 29 Nov 2016 Jazz Pharmaceuticals announces intention to submit sNDA to the US FDA in late 2017 (Jazz Pharmaceuticals pipeline, November 2016)
  • 08 Nov 2016 Jazz Pharmaceuticals completes enrolment in the phase II trial for Narcolepsy (In adolescents, In children) in (US, Finland, France, Italy,Netherlands) (NCT02221869)
  • 01 Sep 2014 Phase-III clinical trials in Narcolepsy (In children, In adolescents) in USA (PO)
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