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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: 14 Aug 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; Thalassaemia
  • Preregistration Sickle cell anaemia
  • Phase III Alpha-thalassaemia; Beta-thalassaemia; Haemolytic anaemia
  • Preclinical Diamond-Blackfan syndrome
  • No development reported Hereditary spherocytosis

Most Recent Events

  • 04 Aug 2026 Agios Pharmaceuticals initiates enrolment in a phase III trial for sickle cell anaemia (In children, In adolescents, In adults, In the elderly) in the USA (NCT07656415)
  • 03 Aug 2026 Phase-III clinical trials in Alpha-thalassaemia (In adolescents, In children, In infants) in USA (PO, Granules) (NCT07506863)
  • 03 Aug 2026 Phase-III clinical trials in Alpha-thalassaemia (In adolescents, In children, In infants) in USA (PO, Tablet) (NCT07506863)

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