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Givinostat - Italfarmaco

Drug Profile

Givinostat - Italfarmaco

Alternative Names: ITF-2357

Latest Information Update: 02 Oct 2021

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At a glance

  • Originator Italfarmaco
  • Developer Italfarmaco; Radboud University
  • Class Amines; Anti-inflammatories; Antineoplastics; Antirheumatics; 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 - Polycythaemia vera; Duchenne muscular dystrophy; Juvenile rheumatoid arthritis
  • 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

  • 26 Aug 2021 Biomarkers information updated
  • 26 Jun 2021 Efficacy and adverse events data from a phase II trial in Duchenne muscular dystrophy (Becker Muscular Dystrophy) presented at the virtual Parent Project Muscular Dystrophy annual conference (PPMD-2021)
  • 18 Jun 2021 Italfarmaco completes a phase I trial in Polycythaemia vera (In volunteers) and Duchenne muscular dystrophy (In volunteers) in Canada (PO, Suspension) (NCT04821063)
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