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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: 01 Apr 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

  • 31 Mar 2026 According to an Agios Pharmaceuticals media release, company announced that it will pursue U.S. accelerated approval for mitapivat, in sickle cell disease, following completion of its pre-supplemental New Drug Application (sNDA) meeting with the U.S. Food and Drug Administration (FDA).
  • 12 Jan 2026 According to an Agios Pharmaceuticals media release, data from this trial will be presented at J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026.
  • 12 Jan 2026 According to an Agios Pharmaceuticals media release, the company plans to submit a U.S. marketing application for mitapivat in sickle cell disease following pre-supplemental New Drug Application (sNDA) meeting with the FDA in the first quarter of 2026.

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