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Mitapivat - Agios Pharmaceuticals

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Drug Profile

Mitapivat - Agios Pharmaceuticals

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

Latest Information Update: 16 Jun 2025

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

Highest Development Phases

  • Marketed Inborn error pyruvate metabolism disorders
  • Preregistration Thalassaemia
  • Phase III Haemolytic anaemia
  • Phase II/III Sickle cell anaemia
  • Preclinical Hereditary spherocytosis

Most Recent Events

  • 09 Jun 2025 Mitapivat licensed to Avanzanite Bioscience in European Economic Area, the UK and Switzerland
  • 01 May 2025 Agios Pharmaceuticals plans a phase II trial for Sickle cell anaemia and Kidney disorders (In adolescents, In adults, In the elderly) (PO) in April 2025 (NCT06286046)
  • 02 Apr 2025 Agios Pharmaceuticals completes the phase II DRIVE PK trial in Inborn error pyruvate metabolism disorders in USA, Canada, France, Italy, Netherlands, United Kingdom (PO) (NCT02476916)

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