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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Subjects With Pyruvate Kinase Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Mar 2021

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At a glance

  • Drugs Mitapivat (Primary)
  • Indications Pyruvate kinase deficiency of red cells
  • Focus Registrational; Therapeutic Use
  • Acronyms ACTIVATE
  • 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.
    • 11 Jan 2021 According to an Agios Pharmaceuticals media release, data from this study will be submitted for presentation at the European Hematology Association (EHA) Virtual Congress, which will be held from 9th Jun to 17th Jun 2021.
    • 08 Dec 2020 Results of pooled pre-treatment baseline data from 3 clinical trials (DRIVE-PK, ACTIVATE and ACTIVATE-T), presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology.
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