Drug Profile


Alternative Names: 2-Fluoro-ARA-AMP; Beneflur; Fludara; Fludarabine phosphate; NSC 312887

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Southern Research Institute
  • Developer Bayer HealthCare Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme
  • Class Antineoplastics; Arabinonucleosides; Myeloablative agonists; Purine nucleosides; Small molecules
  • Mechanism of Action DNA synthesis inhibitors; Immunosuppressants
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma; Non-Hodgkin's lymphoma
  • Phase I/II Acute myeloid leukaemia

Most Recent Events

  • 01 Dec 2016 Genzyme completes a phase I/II trial in Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater) in Spain (IV) (NCT01435343)
  • 15 Mar 2016 Biomarkers information updated
  • 06 Aug 2014 Fludarabine licensed to Emcure Pharmaceuticals in India
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