Mitapivat Clinical Trials (2026): 19 Studies for Healthy Volunteers & Sickle Cell Disease
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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19 Mitapivat clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 10 indications (including Healthy Volunteers & Sickle Cell Disease) and 1,219 total planned enrollment. 7 Phase 3 Mitapivat trials and 3 Phase 2, 1 Phase 4 are listed. 5 Mitapivat clinical trials are actively recruiting. Most recent activity: NCT07506863 (Jun 2032).
Mitapivat clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | enrolling by invitation | completed | withdrawn | not yet recruiting | Total |
|---|---|---|---|---|---|---|---|
| P1 | 6 | 6 | |||||
| P1/P2 | 1 | 1 | |||||
| P2 | 1 | 1 | 1 | 3 | |||
| P2/P3 | 1 | 1 | |||||
| P3 | 4 | 1 | 2 | 7 | |||
| P4 | 1 | 1 |
Recruiting Mitapivat clinical trials (5)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07506863 | ENERGIZEKids-TA Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT) | P3 | Transfusion-dependent Alpha-Thalassemia | 54 | Sep 2026 |
| NCT07517133 | ENERGIZEKidsA Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia | P3 | Non-Transfusion-dependent Alpha-Thalassemia | 45 | Sep 2026 |
| NCT05777993 | A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study | P4 | Pyruvate Kinase Deficiency | 6 | Jul 2023 |
| NCT07055243 | SATISFY-CATo Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII. | P2 | Anemia | 9 | Jun 2025 |
| NCT05935202 | SATISFYSafety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies | P2 | Hereditary Red Blood Cell Disorder (Disorder) | 25 | Dec 2023 |
Mitapivat clinical trials by indication
Healthy Volunteers (4)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04696393 | — | P1 | completed | 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 |
| NCT04565678 | — | P1 | completed | A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants |
| NCT04472832 | AG-348 | P1 | completed | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants |
| NCT03991312 | AG-348 | P1 | completed | 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 |
Sickle Cell Disease (3)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05031780 | AG-348 | P2/P3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP) |
| NCT06286046 | — | P2 | withdrawn | A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy |
| NCT04610866 | — | P1/P2 | active not recruiting | 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 |
Non-Transfusion-dependent Alpha-Thalassemia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07517133 | ENERGIZEKids | P3 | not yet recruiting | A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia |
| NCT04770753 | — | P3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT) |
Transfusion-dependent Alpha-Thalassemia (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07506863 | ENERGIZEKids-T | P3 | not yet recruiting | 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) |
| NCT04770779 | ENERGIZE-T | P3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT) |
Pyruvate Kinase Deficiency (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05777993 | — | P4 | enrolling by invitation | A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study |
| NCT03853798 | — | P3 | completed | Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007 |
Pediatric Pyruvate Kinase Deficiency (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05175105 | ACTIVATE-Kids | P3 | active not recruiting | 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 |
| NCT05144256 | ACTIVATE-KidsT | P3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period |
Anemia (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07055243 | SATISFY-CA | P2 | recruiting | To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII. |
Healthy Participants (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06648824 | — | P1 | completed | Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants |
Hereditary Red Blood Cell Disorder (Disorder) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05935202 | SATISFY | P2 | not yet recruiting | Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies |
Moderate Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05610657 | — | P1 | completed | A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function |
Mitapivat pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| ENERGIZEKids-T | NCT07506863 | P3 | not yet recruiting | Transfusion-dependent Alpha-Thalassemia | 54 | — |
| ENERGIZEKids | NCT07517133 | P3 | not yet recruiting | Non-Transfusion-dependent Alpha-Thalassemia | 45 | — |
| ACTIVATE-Kids | NCT05175105 | P3 | active not recruiting | Pediatric Pyruvate Kinase Deficiency | 30 | — |
| ACTIVATE-KidsT | NCT05144256 | P3 | active not recruiting | Pediatric Pyruvate Kinase Deficiency | 49 | — |
| ENERGIZE-T | NCT04770779 | P3 | active not recruiting | Transfusion-dependent Alpha-Thalassemia | 258 | — |
| SATISFY-CA | NCT07055243 | P2 | recruiting | Anemia | 9 | — |
| SATISFY | NCT05935202 | P2 | not yet recruiting | Hereditary Red Blood Cell Disorder (Disorder) | 25 | — |
Terminated and withdrawn Mitapivat trials (1)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT06286046withdrawnA Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy
All Mitapivat trials (19)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07506863 | ENERGIZEKids-T | 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) | P3 | not yet recruiting | 54 | Agios Pharmaceuticals, Inc. | Sep 2026 |
| NCT07517133 | ENERGIZEKids | A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia | P3 | not yet recruiting | 45 | Agios Pharmaceuticals, Inc. | Sep 2026 |
| NCT05031780 | AG-348 | A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP) | P2/P3 | active not recruiting | 286 | Agios Pharmaceuticals, Inc. | Feb 2022 |
| NCT05175105 | ACTIVATE-Kids | 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 | P3 | active not recruiting | 30 | Agios Pharmaceuticals, Inc. | Jun 2022 |
| NCT05777993 | A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study | P4 | enrolling by invitation | 6 | Agios Pharmaceuticals, Inc. | Jul 2023 | |
| NCT05144256 | ACTIVATE-KidsT | A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period | P3 | active not recruiting | 49 | Agios Pharmaceuticals, Inc. | Jun 2022 |
| NCT04770779 | ENERGIZE-T | A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT) | P3 | active not recruiting | 258 | Agios Pharmaceuticals, Inc. | Nov 2021 |
| NCT06286046 | A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy | P2 | withdrawn | 0 | Agios Pharmaceuticals, Inc. | Mar 2026 | |
| NCT04770753 | A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT) | P3 | active not recruiting | 194 | Agios Pharmaceuticals, Inc. | Dec 2021 | |
| NCT04610866 | 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 | P1/P2 | active not recruiting | 15 | National Heart, Lung, and Blood Institute (NHLBI) | Dec 2020 | |
| NCT07055243 | SATISFY-CA | To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII. | P2 | recruiting | 9 | University Health Network, Toronto | Jun 2025 |
| NCT05935202 | SATISFY | Safety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies | P2 | not yet recruiting | 25 | EuroBloodNet Association | Dec 2023 |
| NCT06648824 | Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants | P1 | completed | 20 | Agios Pharmaceuticals, Inc. | Oct 2024 | |
| NCT03853798 | Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007 | P3 | completed | 90 | Agios Pharmaceuticals, Inc. | Mar 2019 | |
| NCT05610657 | A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function | P1 | completed | 20 | Agios Pharmaceuticals, Inc. | Jan 2023 | |
| NCT04696393 | 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 | P1 | completed | 26 | Agios Pharmaceuticals, Inc. | Jan 2021 | |
| NCT04565678 | A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants | P1 | completed | 32 | Agios Pharmaceuticals, Inc. | Sep 2020 | |
| NCT04472832 | AG-348 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants | P1 | completed | 32 | Agios Pharmaceuticals, Inc. | Jun 2020 |
| NCT03991312 | AG-348 | 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 | P1 | completed | 28 | Agios Pharmaceuticals, Inc. | Jun 2019 |
Mitapivat clinical trials: frequently asked questions
- How many Mitapivat clinical trials are there?
- 19 Mitapivat clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 2 are actively recruiting participants. 7 are marked completed.
- Are Mitapivat clinical trials recruiting in 2026?
- Yes — 2 Mitapivat trials are actively recruiting in 2026. See the recruiting trials and the per-state site list further down this page.
- What conditions is Mitapivat being studied for?
- Mitapivat is being studied for Healthy Volunteers, Sickle Cell Disease, Transfusion-dependent Beta-Thalassemia, Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia and 11 more. The trials are grouped by indication on this page.
- What phase is Mitapivat in?
- Mitapivat clinical trials span 1 Phase 4, 7 Phase 3, 3 Phase 2, 6 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Mitapivat clinical trials?
- The lead sponsor across the most Mitapivat trials is Agios Pharmaceuticals, Inc., with 3 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Mitapivatas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: