Defibrotide

Drug Profile

Defibrotide

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

Latest Information Update: 14 Oct 2016

Price : $50

At a glance

  • Originator Gentium
  • Developer Gentium; Jazz Pharmaceuticals plc; Swedish Orphan Biovitrum
  • 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
  • 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.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

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

Most Recent Events

  • 28 Sep 2016 Phase-III clinical trials in Veno-occlusive disorders (Prevention, In adolescents, In adults, In children, In infants, In the elderly) in USA (IV) (NCT02851407)
  • 12 Aug 2016 Gentium completes a clinical trial for Veno-occlusive disorders (Prevention) in Japan (UMIN000013455)
  • 28 Jul 2016 Jazz Pharmaceuticals plans a phase III trial for Veno-occlusive disorder (Prevention, In adolescents, In adults, In children, In the elderly, In infants) (IV) (NCT02851407)
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