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Defibrotide - Jazz Pharmaceuticals

Drug Profile

Defibrotide - Jazz Pharmaceuticals

Alternative Names: Defibrotide sodium; Defitelio; Fraction P; JZP-381; Noravid; NS 73; Prociclide

Latest Information Update: 27 May 2020

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At a glance

  • Originator Gentium
  • Developer Fukushima Medical University; Gentium; Jazz Pharmaceuticals plc; Nippon Shinyaku; Swedish Orphan Biovitrum; University of California at San Francisco
  • Class Antithrombotics; Nucleotide aptamers; Polydeoxyribonucleotides
  • Mechanism of Action Angiogenesis inhibitors; Heparanase inhibitors; Platelet aggregation inhibitors
  • Orphan Drug Status

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

    Yes - Graft-versus-host disease; Veno-occlusive disorders
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Veno-occlusive disorders
  • Phase II Graft-versus-host disease; Neurological disorders; Thrombotic microangiopathies
  • Market Withdrawal Deep vein thrombosis; Thrombosis
  • No development reported Diabetic nephropathies; Multiple myeloma

Most Recent Events

  • 12 May 2020 Jazz Pharmaceuticals completes its phase II trial for Graft-versus-host disease (Adjunctive treatment, In adolescents, In adults, In children, In infants, In the elderly, Prevention) in USA, Spain, Austria, Belgium, Bulgaria, France, Germany, Greece, Italy, Canada, Poland, Portugal, Croatia and the UK (IV) (NCT03339297)
  • 29 Apr 2020 Jazz Pharmaceuticals discontinues the phase III Harmony trial for Veno-occlusive disorders (In adolescents, In children, In the elderly, In infants, Prevention, In adults) in Australia, Belgium, Canada, France, Germany, Israel, Italy, Japan, South Korea, New Zealand, Spain, Turkey, United Kingdom (IV) on recommendation of Independent Data Monitoring Committee (NCT02851407)
  • 18 Mar 2020 Loyola University plans a phase II trial for hepatic Veno-occlusive disorders in US in May 2020 (NCT04313036)
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