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Placebo Matching Mitapivat

DRUG5 trials

Sponsors

Agios Pharmaceuticals Inc., Agios Pharmaceuticals, Inc.

Conditions

Non-Transfusion-Dependent Alpha- or Beta-ThalassemiaNon-Transfusion-dependent Alpha-ThalassemiaNon-Transfusion-dependent Beta-ThalassemiaTransfusion-Dependent Alpha- or Beta-ThalassemiaTransfusion-dependent Alpha-ThalassemiaTransfusion-dependent Beta-Thalassemia

Phase 3

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
Active, not recruitingNCT04770779
Agios Pharmaceuticals, Inc.Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Start: 2021-11-30End: 2029-06-01Updated: 2026-08-27
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Active, not recruitingNCT04770753
Agios Pharmaceuticals, Inc.Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Start: 2021-12-20End: 2028-12-01Updated: 2026-08-27
A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
RecruitingNCT07517133
Agios Pharmaceuticals, Inc.Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Start: 2026-09-01End: 2032-03-01Target: 45Updated: 2026-08-27
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With α- or β-Transfusion-Dependent Thalassemia (ENERGIZEKids-T)
Not yet recruitingCTIS2025-524707-71-00
Agios Pharmaceuticals Inc.Transfusion-Dependent Alpha- or Beta-Thalassemia
Target: 8Updated: 2026-08-21
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With α- or β-Non–Transfusion-Dependent Thalassemia (ENERGIZEKids)
Not yet recruitingCTIS2025-524706-15-00
Agios Pharmaceuticals Inc.Non-Transfusion-Dependent Alpha- or Beta-Thalassemia
Target: 1Updated: 2026-08-21

Related Papers

Understanding health literacy among patients with thalassemia: Results from a global patient survey by the Thalassemia Advocacy Advisory Council
Blood2025-11-03
Long-term transfusion-free duration and impact on transfusion-related burdens: Results from the ongoing ENERGIZE-T open-label extension study of mitapivat in transfusion-dependent alpha- or beta-thalassemia
Blood2025-11-03
Efficacy of mitapivat in patients with transfusion-dependent alpha-thalassemia: Subgroup analysis from the ENERGIZE-T trial
Blood2025-11-03
Mitapivat in adults with non-transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE): a phase 3, international, randomised, double-blind, placebo-controlled trial.
2025-06-195 citations
Long‐term efficacy and safety of mitapivat in non‐transfusion‐dependent α‐ or β‐thalassaemia: An open‐label phase 2 study
British Journal of Haematology2025-05-201 citations
ENERGIZE-T: A Global, Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Mitapivat in Adults with Transfusion-Dependent Alpha- or Beta-Thalassemia
Blood2024-11-054 citations
<i>Ex Vivo</i> Treatment By Mitapivat, an Allosteric Pyruvate Kinase Activator, Reduced Hemolysis and Reactive Oxygen Species in Red Blood Cells of Non-Transfusion Dependent Hemolytic Anemic Patients Due to β-Thalassemia/Hb E Disease
Blood2024-11-05
Understanding Health Literacy Among Patients with Thalassemia: A Global Patient Survey by the Thalassemia Advocacy Advisory Council
Blood2024-11-05
ENERGIZE: A GLOBAL PHASE 3 STUDY OF MITAPIVAT DEMONSTRATING EFFICACY AND SAFETY IN ADULTS WITH ALPHA- OR BETA-NON–TRANSFUSION-DEPENDENT THALASSEMIA
Hematology Transfusion and Cell Therapy2024-10-012 citations
One-year safety and efficacy of mitapivat in sickle cell disease: follow-up results of a phase 2, open-label study
Blood Advances2023-11-0720 citations
<i>Ex Vivo</i> Treatment By Mitapivat, an Allosteric Pyruvate Kinase Activator, Reduced Oxidative Stress and Promoted Terminal Erythropoiesis in a Severe Hemolytic Anemia Patient Due to Krϋppel-like Factor 1 Mutations
Blood2023-11-02
LONG-TERM EFFICACY AND SAFETY OF THE ORAL PYRUVATE KINASE ACTIVATOR MITAPIVAT IN ADULTS WITH NON–TRANSFUSION-DEPENDENT ALPHA- OR BETA-THALASSEMIA
Hematology Transfusion and Cell Therapy2022-10-011 citations