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Mitapivat - Agios Pharmaceuticals

Drug Profile

Mitapivat - Agios Pharmaceuticals

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

Latest Information Update: 19 Apr 2021

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At a glance

  • Originator Agios Pharmaceuticals
  • Developer Agios Pharmaceuticals; National Heart, Lung and Blood Institute
  • Class Antianaemics; 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 metabolic disorders; Thalassaemia; Sickle cell anaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Inborn error metabolic disorders
  • Phase II Thalassaemia
  • Phase I Sickle cell anaemia
  • Preclinical Haemolytic anaemia

Most Recent Events

  • 29 Apr 2021 Agios Pharmaceuticals plans to submit Marketing Authorisation Application for mitapivat in Inborn error metabolic disorders in the European Union in the mid of 2021
  • 15 Apr 2021 Agios Pharmaceuticals completes a phase I trial pharmacokinetic trial (In volunteers) in USA (PO, Tablet)(NCT04696393)
  • 25 Feb 2021 Agios Pharmaceuticals plans the phase III ENERGIZE-T trial for Thalassaemia (transfusion-dependent ß- or a-thalassemia) in June 2021 (NCT04770779)
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