Givinostat - Italfarmaco

Drug Profile

Givinostat - Italfarmaco

Alternative Names: ITF-2357

Latest Information Update: 29 Dec 2017

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At a glance

  • Originator Italfarmaco
  • Developer Italfarmaco; Radboud University
  • Class Amines; Antineoplastics; Carbamates; Hydroxamic acids; Small molecules
  • Mechanism of Action Histone deacetylase inhibitors
  • Orphan Drug Status

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

    Yes - Juvenile rheumatoid arthritis; Polycythaemia vera
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Duchenne muscular dystrophy
  • Phase II Myeloproliferative disorders
  • Phase I/II Polycythaemia vera
  • No development reported Hereditary autoinflammatory diseases; Juvenile rheumatoid arthritis
  • Discontinued Diffuse large B cell lymphoma; Hodgkin's disease; Multiple myeloma

Most Recent Events

  • 12 Dec 2017 Italfarmaco initiates enrolment in a phase II trial for Duchenne muscular dystrophy (Becker Muscular Dystrophy) in Italy (PO) (NCT03238235)
  • 12 Dec 2017 Italfarmaco completes a phase I/II trial for Duchenne muscular dystrophy (In children) in Italy (NCT01761292)
  • 11 Dec 2017 Efficacy and adverse events data from a phase Ib\II in Polycythemia vera and phase II trial in Chronic myeloproliferative neoplasms presented at the 59th Annual Meeting and Exposition of the American Society of Haematology (ASH-Hem 2017)
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