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A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease

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Trial Profile

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 27 May 2026

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At a glance

  • Drugs Mitapivat (Primary)
  • Indications Sickle cell anaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms RISE-UP
  • Sponsors Agios Pharmaceuticals

Most Recent Events

  • 12 May 2026 Results presented in an Agios Pharmaceuticals Media Release
  • 12 May 2026 According to an Agios Pharmaceuticals media release, data from this study will be presented at the 31st European Hematology Association (EHA) Congress on June 13, 2026, in Stockholm, Sweden.
  • 12 May 2026 According to an Agios Pharmaceuticals media release, company announced the submission of its supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the U.S. accelerated approval of mitapivat following agreement with FDA on the confirmatory clinical trial based on the data from RISE-UP trial.

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