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Givinostat - Italfarmaco

Drug Profile

Givinostat - Italfarmaco

Alternative Names: DUVYZAT; Givinostat hydrochloride hydrate- Italfarmaco; Givinostat hydrochloride monohydrate - Italfarmaco; ITF-2357

Latest Information Update: 26 Mar 2024

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At a glance

  • Originator Italfarmaco; Sanford Burnham Prebys Medical Discovery Institute
  • Developer Italfarmaco
  • Class Amines; Anti-inflammatories; Antineoplastics; Antirheumatics; Benzene derivatives; Carbamates; Ethylamines; Hydroxamic acids; Naphthalenes; 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 - Duchenne muscular dystrophy; Polycythaemia vera
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Duchenne muscular dystrophy
  • Phase III Polycythaemia vera
  • Phase II Myeloproliferative disorders
  • Discontinued Chronic lymphocytic leukaemia; Crohn's disease; Diffuse large B cell lymphoma; Hereditary autoinflammatory diseases; Hodgkin's disease; Juvenile rheumatoid arthritis; Multiple myeloma

Most Recent Events

  • 26 Mar 2024 Chemical structure information updated
  • 22 Mar 2024 ITF Therapeutics (a subsidiary of Italfarmaco) intends to launch givinostat for Duchenne muscular dystrophy in the US (PO) in the third quarter of 2024 (ITF Therapeutics website, March 2024)
  • 21 Mar 2024 Registered for Duchenne muscular dystrophy (In adults, In adolescents, In children) in USA (PO) - First global approval
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