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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: 31 Mar 2025

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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

  • 28 Mar 2025 Planned primary completion date changed from 1 Dec 2025 to 1 Oct 2025.
  • 13 Jan 2025 According to an Agios Pharmaceuticals media release, company anticipate to announce topline results from the Phase 3 RISE UP study of mitapivat in sickle cell disease in late 2025, with a potential U.S. commercial launch in 2026.
  • 18 Dec 2024 According to an Agios Pharmaceuticals media release, company today announced that European Commission has adopted a positive decision for the designation of mitapivat, as an orphan medicinal product (OMP) for the treatment of sickle cell disease.

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