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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR AG-348


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Clinical Trials for AG-348

Trial ID Title Status Sponsor Phase Summary
NCT02108106 ↗ A Phase I Study of AG-348 in Healthy Volunteers Completed Agios Pharmaceuticals, Inc. Phase 1 This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
NCT02149966 ↗ A Phase I Study of AG-348 in Healthy Volunteers Completed Agios Pharmaceuticals, Inc. Phase 1 This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
NCT02476916 ↗ A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency Active, not recruiting Agios Pharmaceuticals, Inc. Phase 2 Study AG348-C-003 is a multicenter study designed to evaluate the safety and efficacy of different dose levels of AG-348 (mitapivat) in participants with PK deficiency.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for AG-348

Condition Name

Condition Name for
Intervention Trials
Healthy Volunteers 6
Pyruvate Kinase Deficiency 5
Sickle Cell Disease 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Pyruvate Metabolism, Inborn Errors 6
Anemia, Hemolytic, Congenital Nonspherocytic 6
Anemia, Hemolytic 6
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Clinical Trial Locations for AG-348

Trials by Country

Trials by Country for
Location Trials
United States 48
Canada 9
France 6
Japan 6
United Kingdom 5
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Trials by US State

Trials by US State for
Location Trials
Massachusetts 7
Texas 6
California 6
Maryland 4
Georgia 3
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Clinical Trial Progress for AG-348

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 12
Not yet recruiting 5
Recruiting 3
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Clinical Trial Sponsors for AG-348

Sponsor Name

Sponsor Name for
Sponsor Trials
Agios Pharmaceuticals, Inc. 21
National Heart, Lung, and Blood Institute (NHLBI) 3
National Institutes of Health Clinical Center (CC) 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 21
NIH 4
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