mitapivat
mitapivat: sourced relationships with 1 company · 15 clinical trials tracked.
mitapivat evidence translation
What we can confirm
15 tracked trials
What it means
What to watch
Prepared research question
How could mitapivat → AGIO affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| AGIOS PHARMACEUTICALS, INC. (AGIO) Hemolytic anemia in adults with PK deficiency; being evaluat… | Approved |
Clinical Trial Registry Records (15)showing 10 most recent
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
Primary endpoint: Percentage of Participants Who Achieved a Hemoglobin (Hb) Response
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
Primary endpoint: Percentage of Participants Who Achieved Transfusion Reduction Response (TRR) Through Week 48
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease
Primary endpoint: Percentage of Subjects who are Transfusion Free From Week 4 Through Week 52
A Phase 2, Open-label, Multicenter Study of Mitapivat in Subjects With Sickle Cell Disease and Nephropathy (RESIST)
Primary endpoint: Percentage of Participants With Albumin Creatinine Ratio (ACR) Response
Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies - Canada (SATISFY-CA)
Primary endpoint: To evaluate safety of mitapivat
A Rollover Study to Provide Continued Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Primary endpoint: Not applicable as this protocol is to provide an option for continued access to mitapivat for participants who have previously participated in an Agios-sponsored mitapivat study
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Regularly Transfused, Followed by a 5-Year Open-label Extension Period
Primary endpoint: Percentage of Participants Achieving Transfusion Reduction Response (TRR)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Subjects With Pyruvate Kinase Deficiency Who Are Not Regularly Transfused, Followed by a 5-Year Open-label Extension Period
Primary endpoint: Percentage of Participants Achieving a Hemoglobin (Hb) Response
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
Primary endpoint: Phase 2: Percentage of Participants With Hemoglobin (Hb) Response
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)
Primary endpoint: Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline
Frequently asked questions
Which companies have sourced relationships with mitapivat?
mitapivat has dated SEC/FDA relationship records for AGIOS PHARMACEUTICALS, INC..
How many clinical trials involve mitapivat?
BioSniper tracks 15 clinical trials involving mitapivat.