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A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)

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Trial Profile

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE)

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

Latest Information Update: 08 May 2025

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At a glance

  • Drugs Mitapivat (Primary)
  • Indications Alpha-thalassaemia; Beta-thalassaemia; Thalassaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENERGIZE
  • Sponsors Agios Pharmaceuticals

Most Recent Events

  • 01 May 2025 According to an Agios Pharmaceuticals media release, company progressing the review of regulatory applications with health authorities in the European Union, Kingdom of Saudi Arabia and United Arab Emirates.
  • 29 Jan 2025 Last checked against ClinicalTrials.gov record.
  • 08 Jan 2025 According to an Agios Pharmaceuticals media release,based on the results from the ENERGIZE and ENERGIZE-T Phase 3 trials, the U.S. Food and Drug Administration (FDA) accepted the companys supplemental New Drug Application (sNDA) for PYRUKYND (mitapivat) . The review classification for this application is Standard and the Prescription Drug User Fee Act (PDUFA) goal date is September 7,2025.

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