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An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

Trial Profile

An Open-Label Study To Evaluate the Efficacy and Safety of AG-348 in Regularly Transfused Adult Subjects With Pyruvate Kinase (PK) Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jan 2021

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At a glance

  • Drugs Mitapivat (Primary)
  • Indications Pyruvate kinase deficiency of red cells
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVATE-T
  • Sponsors Agios Pharmaceuticals
  • Most Recent Events

    • 26 Jan 2021 According to an Agios Pharmaceuticals media release, the company anticipates filing for regulatory approval for Mitapivat for the treatment of adults with Pyruvate Kinase (PK) Deficiency based on data from ACTIVATE and ACTIVATE-T in the U.S. in Q2 2021 and in the EU in mid-2021.
    • 26 Jan 2021 Primary endpoint has been met. (Percentage of Participants Achieving a Reduction in Transfusion Burden in Part 2), according to an Agios Pharmaceuticals media release.
    • 26 Jan 2021 Results published in the Agios Pharmaceuticals Media Release.
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