Agios Pharmaceuticals Inc
AGIOHealthcare|Biotechnology|USA
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Clinical Trials (60)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT04770779 A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT) | Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia | P3 | Active | 258 | RCT, Double-blind | Placebo Matching Mitapivat, Mitapivat |
| NCT05175105 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 | Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia | P3 | Active | 30 | RCT, Double-blind | Mitapivat, Mitapivat-matching placebo |
| NCT05031780 A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP) | Sickle Cell Disease | P2P3 | Active | 286 | RCT, Double-blind | Mitapivat |
| NCT04770753 A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT) | Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia | P3 | Active | 194 | RCT, Double-blind | Placebo Matching Mitapivat, Mitapivat |
| NCT05144256 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 | Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia | P3 | Active | 49 | RCT, Double-blind | Mitapivat, Mitapivat-matching placebo |
| NCT03692052 A Study to Determine the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Participants With Non-transfusion-dependent Thalassemia | Thalassemia | P2 | Active | 20 | Open-label | AG-348 |
| NCT05490446 A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) | Myelodysplastic Syndromes | P2 | Active | 87 | Open-label | Tebapivat |
| NCT04278781 AG-120 in People With IDH1 Mutant Chondrosarcoma | Chondrosarcoma, Chondrosarcoma, Grade 2 | P2 | Active | 6 | Open-label | AG-120 |
| NCT07055243 To Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII. | Anemia | P2 | Recruiting | 9 | Open-label | Mitapivat |
| NCT06924970 A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD) | Sickle Cell Disease | P2 | Active | 59 | RCT, Double-blind | Tebapivat, Tebapivat Matched Placebo |
| NCT07241234 A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria | Phenylketonuria | P1 | Recruiting | 20 | Open-label | AG-181 |
| NCT07075640 A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants | Healthy Participants | P1 | Active | 24 | RCT, Double-blind | AG-236, Placebo |
| NCT03481738 Pyruvate Kinase Deficiency Global Longitudinal Registry | Pyruvate Kinase Deficiency | Active | 500 | — | — | |
| NCT05777993 A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study | Pyruvate Kinase Deficiency, Anemia, Hemolytic | P4 | By Invite | 6 | Open-label | Mitapivat |
| NCT07656415 A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD) | Sickle Cell Disease | P3 | Not Yet Recruiting | 159 | RCT, Double-blind | Mitapivat Matched Placebo, Mitapivat |
| NCT07517133 A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia | Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia | P3 | Not Yet Recruiting | 45 | RCT, Double-blind | Mitapivat, Placebo Matching Mitapivat |
| NCT03548220 A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD) | Pyruvate Kinase Deficiency, Anemia, Hemolytic | P3 | Completed | 80 | RCT, Double-blind | Placebo, AG-348 |
| NCT07506863 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) | Transfusion-dependent Alpha-Thalassemia, Transfusion-dependent Beta-Thalassemia | P3 | Not Yet Recruiting | 54 | RCT, Double-blind | Mitapivat Matched Placebo, Mitapivat |
| NCT03853798 Extension Study of AG-348 in Adult Participants With Pyruvate Kinase Deficiency Previously Enrolled in AG-348-006 or AG348-C-007 | Pyruvate Kinase Deficiency | P3 | Completed | 90 | Open-label | Mitapivat |
| NCT03559699 A Study Evaluating the Efficacy and Safety of AG-348 in Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD) | Pyruvate Kinase Deficiency, Anemia, Hemolytic | P3 | Completed | 27 | Open-label | AG-348 |
| NCT02476916 A Study of AG-348 in Adult Participants With Pyruvate Kinase (PK) Deficiency | Pyruvate Kinase Deficiency | P2 | Completed | 52 | RCT, Open-label | AG-348 |
| NCT06286046 A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy | Sickle Cell Disease, Nephropathy | P2 | Withdrawn | — | Open-label | Mitapivat |
| NCT01915498 Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation | Hematologic Neoplasms | P1P2 | Completed | 345 | Open-label | Enasidenib |
| NCT04056910 Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors | Advanced Solid Tumor, IDH1 Mutation | P2 | Completed | 15 | Open-label | ivosidenib and nivolumab |
| NCT05610657 A Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function | Moderate Hepatic Impairment | P1 | Completed | 20 | Open-label | Mitapivat |
| NCT04536792 A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease | Healthy Volunteers, Anemia, Sickle Cell | P1 | Completed | 122 | RCT, Double-blind | AG-946, AG-946 Matched Placebo |
| NCT03834584 A Study of AG-636 in the Treatment of Subjects With Advanced Lymphoma | Lymphoma | P1 | Terminated | 11 | Open-label | AG-636 |
| NCT02630927 A Safety and Tolerability Study of AG-519 in Healthy Subjects | Anemia | P1 | Terminated | 108 | RCT, Double-blind | AG-519, Placebo |
| NCT03703505 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 | Healthy Volunteers | P1 | Completed | 8 | Open-label | AG-348, [13C6]AG-348 |
| NCT02492737 Study of Orally Administered AG-881 in Patients With Advanced Hematologic Malignancies With an IDH1 and/or IDH2 Mutation | Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome | P1 | Completed | 46 | Open-label | AG881 |
| 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 | Healthy Volunteers | P1 | Completed | 26 | RCT, Open-label | Mitapivat tablet |
| NCT02579707 Food Effect Study of AG120 in Healthy Subjects | Healthy | P1 | Completed | 36 | RCT, Open-label | AG120 |
| NCT02489513 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 | Healthy Volunteers | P1 | Completed | 8 | Open-label | [14C]-AG-120 |
| NCT03564821 IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation | IDH1 Mutation Myeloid Neoplasms | P1 | Completed | 18 | Open-label | Ivosidenib |
| NCT03250598 Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin | Healthy, Japanese | P1 | Completed | 60 | Open-label | AG-348, AG-348, AG-348 |
| NCT04145128 A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants | Healthy Volunteers | P1 | Completed | 32 | Open-label | AG881 |
| NCT04015687 A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults | Healthy Participants | P1 | Completed | 22 | Open-label | AG-881, Lamotrigine |
| NCT03282513 A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function | Hepatic Impairment | P1 | Completed | 33 | Open-label | AG-120 (Ivosidenib) |
| NCT06648824 Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants | Healthy Participants | P1 | Completed | 20 | Open-label | Mitapivat, Midazolam |
| NCT03960502 A Safety and Pharmacokinetic Study of AG-881 in Healthy Male Participants Following Administration of a Single Oral Dose of [14C] AG-881 and Concomitant Intravenous Microdose of [13C315N3] AG-881 | Healthy Male Participants | P1 | Completed | 5 | Open-label | AG-881, [13C315N3]AG-881 |
| NCT02149966 A Phase I Study of AG-348 in Healthy Volunteers | Healthy Volunteer | P1 | Completed | 48 | RCT, Double-blind | AG-348, Placebo |
| NCT02108106 A Phase I Study of AG-348 in Healthy Volunteers | Healthy Volunteer | P1 | Completed | 48 | RCT, Double-blind | AG-348, Placebo |
| NCT02218346 Food Effect Study of AG-221 in Healthy Male Subjects | Healthy Volunteers | P1 | Completed | 30 | RCT, Open-label | AG221 |
| NCT06286033 Single and Multiple Ascending Dose Study and Food Effect Study for AG181 | Healthy Volunteers | P1 | Completed | 88 | RCT, Double-blind | AG-181, Placebo |
| NCT03071770 Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects | Healthy | P1 | Completed | 60 | Open-label | ivosidenib (AG-120) |
| NCT04565678 A Study to Assess the Relative Bioavailability and Effect of Food on the Coated Granule Formulation of Mitapivat in Healthy Participants | Healthy Volunteers | P1 | Completed | 32 | RCT, Open-label | Mitapivat tablets, Mitapivat coated granules |
| NCT04472832 A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants | Healthy Volunteers | P1 | Completed | 32 | RCT, Double-blind | Placebo for Treatment A, Mitapivat 100 mg, Placebo for Treatment B, Mitapivat 300 mg, Placebo for Treatment C |
| NCT03991312 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 | Healthy Volunteers | P1 | Completed | 28 | Open-label | itraconazole, rifampin, mitapivat sulfate |
| NCT04128787 A Study to Compare the Relative Bioavailability of Two AG-881 Formulations and Evaluate the Effect of Food and Omeprazole on the Pharmacokinetics of AG-881 | Healthy Volunteers | P1 | Completed | 36 | RCT, Open-label | AG881 Formulation 1, AG881 Formulation 2, Omeprazole |
| NCT06745271 A Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy Participants | Healthy Participants | P1 | Completed | 8 | Open-label | [14C]-tebapivat, [13C2,15N3]-tebapivat |
| NCT02831972 Drug-Drug Interaction Study of AG120 in Healthy Subjects | Healthy | P1 | Completed | 22 | Open-label | AG120, Itraconazole |
| NCT03397329 Study to Evaluate the Relative Bioavailability and Safety of the AG-348 Tablet and Capsule Formulations in Healthy Adults | Healthy Volunteers | P1 | Completed | 26 | RCT, Open-label | AG-348 Sequence A, AG-348 Sequence B |
| NCT04964323 Pyruvate Kinase (PK) Deficiency Global Longitudinal Registry: Patient-Reported Outcomes (PRO) | Pyruvate Kinase Deficiency, Pyruvate Kinase Deficiency Anemia | Terminated | 15 | — | — | |
| NCT02053480 Pyruvate Kinase Deficiency Natural History Study | Pyruvate Kinase Deficiency, Congenital Non-Spherocytic Hemolytic Anemia | Completed | 254 | — | — | |
| NCT03245424 Ivosidenib Expanded Access Program in Relapsed/Refractory AML With an IDH1 Mutation | Acute Myeloid Leukemia, Relapsed Adult AML | APPROVED_FOR_MARKETING | — | — | ivosidenib (AG-120) | |
| NCT04995315 Pyruvate Kinase Deficiency Global Longitudinal Registry Substudy of Protocol AG348-C-008 | Pyruvate Kinase Deficiency | Completed | 13 | — | — | |
| NCT03361358 Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma | Advanced Solid Tumors, Lymphoma | Completed | 44 | — | — | |
| NCT04902833 Acquired Pyruvate Kinase Deficiency In Clonal Myeloid Neoplasms | Pyruvate Kinase Deficiency, Pyruvate Kinase Deficiency Anemia | Completed | 18 | — | — | |
| NCT04000165 A Dose-Finding Study of AG-348 in Sickle Cell Disease | Sickle Cell Disease | Early P1 | Completed | 17 | Open-label | AG-348 |
| NCT05384002 An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum | Prostate Cancer, Prostate Cancer Metastatic | Completed | 14,000 | — | — |