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Avatrombopag - Swedish Orphan Biovitrum

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Drug Profile

Avatrombopag - Swedish Orphan Biovitrum

Alternative Names: AKR-501; AKR-501 monomaleate; Avatrombopag maleate; DOPTELET; DOPTELET Sprinkle; E-5501; Su Ke Xin; YM-477

Latest Information Update: 30 Jul 2025

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At a glance

  • Originator Astellas Pharma
  • Developer Dova Pharmaceuticals; Eisai Co Ltd; Shanghai Fosun Pharmaceutical; Swedish Orphan Biovitrum
  • Class Antithrombotics; Piperazines; Piperidines; Pyridines; Small molecules; Thiazoles
  • Mechanism of Action Thrombopoietin receptor agonists
  • Orphan Drug Status

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

    Yes - Thrombocytopenia; Idiopathic thrombocytopenic purpura
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Idiopathic thrombocytopenic purpura; Thrombocytopenia

Most Recent Events

  • 25 Jul 2025 Registered for Thrombocytopenia (In infants, In children, Treatment-experienced) in USA (PO)
  • 25 Jul 2025 Updated efficacy and adverse events data from the phase III AVA-PED-301 trial in Thrombocytopenia released by Swedish Orphan Biovitrum
  • 12 Dec 2024 FDA assigns PDUFA action date of 24/07/2025 for avatrombopag for Thrombocytopenia (In adolescents, In children, In infants)

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