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Mitapivat - Agios Pharmaceuticals

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Drug Profile

Mitapivat - Agios Pharmaceuticals

Alternative Names: AG 348; AG 348-sulfate-hydrate; AQVESME; Mitapivat-sulfate; PYRUKYND

Latest Information Update: 11 Mar 2026

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At a glance

  • Originator Agios Pharmaceuticals
  • Class Antianaemics; Benzene derivatives; Cyclopropanes; Piperazines; Quinolines; Small molecules; Sulfonamides
  • Mechanism of Action Pyruvate kinase stimulants
  • Orphan Drug Status

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

    Yes - Sickle cell anaemia; Inborn error pyruvate metabolism disorders; Thalassaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Inborn error pyruvate metabolism disorders
  • Registered Thalassaemia
  • Phase III Haemolytic anaemia
  • Phase II/III Sickle cell anaemia
  • Preclinical Diamond-Blackfan syndrome; Hereditary spherocytosis

Most Recent Events

  • 02 Mar 2026 Registered for Thalassaemia in United Arab Emirates (PO)
  • 16 Feb 2026 Mitapivat is covered by patent protection worldwide
  • 30 Jan 2026 Agios Pharmaceuticals European patents were upheld by the European Opposition Division after conclusion of adversarial proceedings

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