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Showing 1–24 of 26 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Mitapivat Clear all
Active, not recruiting Phase 3 Interventional Results available

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

NCT04770779
View directory record Official record
Conditions
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Interventions
Placebo Matching Mitapivat, Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
258 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2029
U.S. locations
10
States / cities
Phoenix, Arizona • La Jolla, California • Oakland, California + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 3 Interventional

A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)

NCT07656415
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Mitapivat Matched Placebo, Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
12 Years and older
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
3
States / cities
Indianapolis, Indiana • Grand Rapids, Michigan • Flowood, Mississippi
Source: ClinicalTrials.gov public record
Updated Aug 3, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)

NCT03548220
View directory record Official record
Conditions
Pyruvate Kinase Deficiency, Anemia, Hemolytic
Interventions
Placebo, AG-348
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
12
States / cities
Little Rock, Arkansas • Atlanta, Georgia • Indianapolis, Indiana + 8 more
Source: ClinicalTrials.gov public record
Updated May 23, 2022 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants

NCT04472832
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Placebo for Treatment A, Mitapivat 100 mg, Placebo for Treatment B, Mitapivat 300 mg, Placebo for Treatment C
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Feb 17, 2021 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2Phase 3 Interventional

A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)

NCT05031780
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Mitapivat, Mitapivat-matching placebo
Drug · Other
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
16 Years and older
Enrollment
286 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2030
U.S. locations
28
States / cities
La Jolla, California • Los Angeles, California • Oakland, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants

NCT06648824
View directory record Official record
Conditions
Healthy Participants
Interventions
Mitapivat, Midazolam
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Jan 27, 2025 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Early Phase 1 Interventional Results available

A Dose-Finding Study of AG-348 in Sickle Cell Disease

NCT04000165
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
AG-348
Drug
Lead sponsor
National Institutes of Health Clinical Center (CC)
NIH
Eligibility
18 Years to 70 Years
Enrollment
17 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 11, 2022 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 3 Interventional Results available

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

NCT04770753
View directory record Official record
Conditions
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Interventions
Placebo Matching Mitapivat, Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
194 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2028
U.S. locations
6
States / cities
La Jolla, California • Palo Alto, California • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of AG-348 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C]AG-348 and Concomitant Single Intravenous Microdose of [13C6]AG-348

NCT03703505
View directory record Official record
Conditions
Healthy Volunteers
Interventions
AG-348, [13C6]AG-348
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years · Male only
Enrollment
8 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Oct 11, 2018 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the Effect of Multiple Doses of Itraconazole and Rifampin on the Single-Dose Pharmacokinetics of Mitapivat Sulfate (AG-348) in Healthy Adult Participants

NCT03991312
View directory record Official record
Conditions
Healthy Volunteers
Interventions
itraconazole, rifampin, mitapivat sulfate
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated Oct 22, 2019 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 3 Interventional Results available

Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007

NCT03853798
View directory record Official record
Conditions
Pyruvate Kinase Deficiency
Interventions
Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
12
States / cities
Phoenix, Arizona • Oakland, California • Atlanta, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2025 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 3 Interventional

A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia

NCT07517133
View directory record Official record
Conditions
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Interventions
Mitapivat, Placebo Matching Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 17 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
4
States / cities
Palo Alto, California • New York, New York • Philadelphia, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

NCT05175105
View directory record Official record
Conditions
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
Interventions
Mitapivat, Mitapivat-matching placebo
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 17 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2030
U.S. locations
11
States / cities
Palo Alto, California • Aurora, Colorado • Atlanta, Georgia + 8 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase I Study of AG-348 in Healthy Volunteers

NCT02108106
View directory record Official record
Conditions
Healthy Volunteer
Interventions
AG-348, Placebo
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 21, 2014 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting No phase listed Observational

Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease

NCT05675436
View directory record Official record
Conditions
Sickle Cell Anemia, Sickle Cell Thalassemia, Sickle Cell Pain, Hbss, Hbsc, Sickle Beta Thalassemia, Sickle Beta Zero Thalassemia, Sickle Cell Syndrome Variant
Interventions
Not listed
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Eligibility
16 Years to 80 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function

NCT05610657
View directory record Official record
Conditions
Moderate Hepatic Impairment
Interventions
Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
3
States / cities
Tustin, California • Miami, Florida • Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Sep 20, 2023 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin

NCT03250598
View directory record Official record
Conditions
Healthy, Japanese, Non-Asian
Interventions
AG-348
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Cypress, California
Source: ClinicalTrials.gov public record
Updated Oct 18, 2017 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 2 Interventional Results available

A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia

NCT03692052
View directory record Official record
Conditions
Thalassemia
Interventions
AG-348
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2030
U.S. locations
2
States / cities
Oakland, California • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 29, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants

NCT04565678
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Mitapivat tablets, Mitapivat coated granules
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Dec 9, 2020 · Synced Sep 1, 2026, 1:44 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat

NCT04610866
View directory record Official record
Conditions
Sickle Cell Disease, Hemolytic Anemia
Interventions
Mitapivat
Drug
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Eligibility
18 Years to 70 Years
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2028
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Recruiting Phase 3 Interventional

A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

NCT07506863
View directory record Official record
Conditions
Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia
Interventions
Mitapivat Matched Placebo, Mitapivat
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
1 Year to 17 Years
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2032
U.S. locations
3
States / cities
New York, New York • Philadelphia, Pennsylvania • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants

NCT04696393
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Mitapivat tablet
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 64 Years
Enrollment
26 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Apr 12, 2021 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 2 Interventional Results available

A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency

NCT02476916
View directory record Official record
Conditions
Pyruvate Kinase Deficiency
Interventions
AG-348
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2025
U.S. locations
7
States / cities
Palo Alto, California • Boston, Massachusetts • Detroit, Michigan + 4 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Sep 1, 2026, 1:44 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase I Study of AG-348 in Healthy Volunteers

NCT02149966
View directory record Official record
Conditions
Healthy Volunteer
Interventions
AG-348, Placebo
Drug
Lead sponsor
Agios Pharmaceuticals, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
48 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Nov 9, 2014 · Synced Sep 1, 2026, 1:44 PM EDT