Mitapivat Sulfate
FDA-approved product (tablet, oral), marketed as Aqvesme, Pyrukynd.
- Registered studies
- 19
- Lab records
- 0
- Pathogens at ≥40%
- 2 of 4
Chemical structure
Existing / approved use
Documented · FDA, WHO, ChEMBLApproved for
- Anemia
- Familial hemolytic anemia
- Genetic disorder
Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗
- WHO therapeutic group
- Other hematological agents
- FDA pharmacologic class
- Pyruvate Kinase Activator FDA label ↗
- Anti-infective classification
- Not classified as an anti-infective.
Repurposing investigation
This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis and MRSA. It was surfaced computationally for further investigation; it is not an established treatment for these infections.
AI-predicted activity
AI prediction · nothing measured- MRSA50.0% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
- E. coli33.2% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
- K. pneumoniae27.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
- M. tuberculosis60.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.
Evidence
Clinical and experimental
Documented evidenceClinical
19registered studies name this medicine, for any condition. See them below.
Experimental
No evidence found
No laboratory measurement against the four pathogens in the ChEMBL records loaded here.
Docking
Computational · nothing measuredAutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.
Other medicines to investigate
AI prediction · nothing measuredOther repurposing candidates: approved medicines besides Mitapivat Sulfate with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.
Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.
- Mefloquine HydrochlorideExisting use: Malaria, Plasmodium falciparum malaria, Plasmodium vivax malaria81.8% AI-predicted activityagainst M. tuberculosisLab records exist8 registered studies
- KetoconazoleExisting use: Adrenal gland disease, Blastomycosis, Cushing syndrome and 3 more81.2% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- LevoketoconazoleExisting use: Adrenal gland disease, Adrenal gland hyperfunction, Cushing syndrome81.2% AI-predicted activityagainst M. tuberculosis6 registered studies
- Fluphenazine DecanoateExisting use: Mental or behavioural disorder, Psychosis80.7% AI-predicted activityagainst M. tuberculosis4 registered studies
- Fluphenazine EnanthateExisting use: Mental or behavioural disorder, Psychosis80.7% AI-predicted activityagainst M. tuberculosisNo documented evidence found
- NifurtimoxExisting use: American trypanosomiasis, Chagas disease, Leishmaniasis and 1 more78.4% AI-predicted activityagainst M. tuberculosis19 registered studies
- Fluphenazine HydrochlorideExisting use: Mental or behavioural disorder, Psychosis77.8% AI-predicted activityagainst M. tuberculosis5 registered studies
- NitazoxanideExisting use: Amebiasis, Diarrhea77.8% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- TopiramateExisting use: Epilepsy, Lennox-Gastaut syndrome, Migraine disorder and 1 more77.4% AI-predicted activityagainst M. tuberculosisLab records exist50+ registered studies
- TrabectedinExisting use: Cancer, Dedifferentiated liposarcoma, Leiomyosarcoma and 7 more76.8% AI-predicted activityagainst M. tuberculosis50+ registered studies
- Chlorpromazine HydrochlorideExisting use: Conduct disorder, Mental or behavioural disorder, Nausea and vomiting and 3 more75.0% AI-predicted activityagainst M. tuberculosis33 registered studies
- ProchlorperazineExisting use: Anxiety disorder, Nausea and vomiting, Psychosis and 1 more74.1% AI-predicted activityagainst M. tuberculosis50+ registered studies
Registered studies
A registration describes a study; it does not establish a positive result.
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 · start 2026-09
Registered record
- Registry ID
- NCT07506863
- Conditions
- Transfusion-dependent Alpha-Thalassemia; Transfusion-dependent Beta-Thalassemia
- Interventions
- Mitapivat Matched Placebo; Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Recruiting
- Start
- 2026-09
- Completion
- 2032-06
- Enrolment
- 54
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionTransfusion-dependent Alpha-Thalassemia; Transfusion-dependent Beta-ThalassemiaInterventionMitapivat Matched Placebo; MitapivatPhasePhase 3Registry statusRecruitingA Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
NCT07517133 · start 2026-09
Registered record
- Registry ID
- NCT07517133
- Conditions
- Non-Transfusion-dependent Alpha-Thalassemia; Non-Transfusion-dependent Beta-Thalassemia
- Interventions
- Mitapivat; Placebo Matching Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Recruiting
- Start
- 2026-09
- Completion
- 2032-03
- Enrolment
- 45
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionNon-Transfusion-dependent Alpha-Thalassemia; Non-Transfusion-dependent Beta-ThalassemiaInterventionMitapivat; Placebo Matching MitapivatPhasePhase 3Registry statusRecruitingA Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
NCT07656415 · start 2026-07-21
Registered record
- Registry ID
- NCT07656415
- Conditions
- Sickle Cell Disease
- Interventions
- Mitapivat Matched Placebo; Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Recruiting
- Start
- 2026-07-21
- Completion
- 2030-08
- Enrolment
- 159
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionSickle Cell DiseaseInterventionMitapivat Matched Placebo; MitapivatPhasePhase 3Registry statusRecruitingA Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy
NCT06286046 · start 2026-03
Registered record
- Registry ID
- NCT06286046
- Conditions
- Sickle Cell Disease; Nephropathy
- Interventions
- Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Withdrawn
- Start
- 2026-03
- Completion
- 2028-12
- Enrolment
- 0
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionSickle Cell Disease; NephropathyInterventionMitapivatPhasePhase 2Registry statusWithdrawnTo Assess Safety of Mitapivat and Provide Proof of Concept of the Efficacy of the Drug in Patients With RBC Membranopathies or CDAII.
NCT07055243 · start 2025-06-26
Registered record
- Registry ID
- NCT07055243
- Conditions
- Anemia
- Interventions
- Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Recruiting
- Start
- 2025-06-26
- Completion
- 2027-06-30
- Enrolment
- 9
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAnemiaInterventionMitapivatPhasePhase 2Registry statusRecruitingStudy of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants
NCT06648824 · start 2024-10-17
Registered record
- Registry ID
- NCT06648824
- Conditions
- Healthy Participants
- Interventions
- Mitapivat; Midazolam
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2024-10-17
- Completion
- 2024-12-03
- Enrolment
- 20
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHealthy ParticipantsInterventionMitapivat; MidazolamPhasePhase 1Registry statusCompletedSafety and Efficacy of Mitapivat Sulfate in Adult Patients With Erythrocyte Membranopathies
NCT05935202 · start 2023-12-21
Registered record
- Registry ID
- NCT05935202
- Conditions
- Hereditary Red Blood Cell Disorder (Disorder)
- Interventions
- Mitapivat sulfate
- Study type
- INTERVENTIONAL
- Phase
- Phase 2
- Registry status
- Not yet recruiting
- Start
- 2023-12-21
- Completion
- 2026-12-15
- Enrolment
- 25
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHereditary Red Blood Cell Disorder (Disorder)InterventionMitapivat sulfatePhasePhase 2Registry statusNot yet recruitingA Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
NCT05777993 · start 2023-07-06
Registered record
- Registry ID
- NCT05777993
- Conditions
- Pyruvate Kinase Deficiency; Anemia, Hemolytic; Sickle Cell Disease; Thalassemia
- Interventions
- Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 4
- Registry status
- Enrolling by invitation
- Start
- 2023-07-06
- Completion
- 2029-08
- Enrolment
- 59
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPyruvate Kinase Deficiency; Anemia, Hemolytic; Sickle Cell Disease; ThalassemiaInterventionMitapivatPhasePhase 4Registry statusEnrolling by invitationA Pharmacokinetic Study of Mitapivat in Participants With Moderate Hepatic Impairment Compared to Matched Healthy Control Participants With Normal Hepatic Function
NCT05610657 · start 2023-01-10
Registered record
- Registry ID
- NCT05610657
- Conditions
- Moderate Hepatic Impairment
- Interventions
- Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2023-01-10
- Completion
- 2023-07-21
- Enrolment
- 20
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionModerate Hepatic ImpairmentInterventionMitapivatPhasePhase 1Registry statusCompletedA 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
NCT05144256 · start 2022-06-08
Registered record
- Registry ID
- NCT05144256
- Conditions
- Pediatric Pyruvate Kinase Deficiency; Pediatric Hemolytic Anemia
- Interventions
- Mitapivat; Mitapivat-matching placebo
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Active not recruiting
- Start
- 2022-06-08
- Completion
- 2029-06
- Enrolment
- 49
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPediatric Pyruvate Kinase Deficiency; Pediatric Hemolytic AnemiaInterventionMitapivat; Mitapivat-matching placeboPhasePhase 3Registry statusActive not recruitingA 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 · start 2022-06-06
Registered record
- Registry ID
- NCT05175105
- Conditions
- Pediatric Pyruvate Kinase Deficiency; Pediatric Hemolytic Anemia
- Interventions
- Mitapivat; Mitapivat-matching placebo
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Active not recruiting
- Start
- 2022-06-06
- Completion
- 2030-01
- Enrolment
- 30
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPediatric Pyruvate Kinase Deficiency; Pediatric Hemolytic AnemiaInterventionMitapivat; Mitapivat-matching placeboPhasePhase 3Registry statusActive not recruitingA Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
NCT05031780 · start 2022-02-11
Registered record
- Registry ID
- NCT05031780
- Conditions
- Sickle Cell Disease
- Interventions
- Mitapivat; Mitapivat-matching placebo; Mitapivat-matching placebo
- Study type
- INTERVENTIONAL
- Phase
- Phase 2 / Phase 3
- Registry status
- Active not recruiting
- Start
- 2022-02-11
- Completion
- 2030-02
- Enrolment
- 286
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionSickle Cell DiseaseInterventionMitapivat; Mitapivat-matching placebo; Mitapivat-matching placeboPhasePhase 2 / Phase 3Registry statusActive not recruitingA Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
NCT04770753 · start 2021-12-20
Registered record
- Registry ID
- NCT04770753
- Conditions
- Non-Transfusion-dependent Alpha-Thalassemia; Non-Transfusion-dependent Beta-Thalassemia
- Interventions
- Placebo Matching Mitapivat; Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Active not recruiting
- Start
- 2021-12-20
- Completion
- 2028-12
- Enrolment
- 194
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionNon-Transfusion-dependent Alpha-Thalassemia; Non-Transfusion-dependent Beta-ThalassemiaInterventionPlacebo Matching Mitapivat; MitapivatPhasePhase 3Registry statusActive not recruitingA Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
NCT04770779 · start 2021-11-30
Registered record
- Registry ID
- NCT04770779
- Conditions
- Transfusion-dependent Alpha-Thalassemia; Transfusion-dependent Beta-Thalassemia
- Interventions
- Placebo Matching Mitapivat; Mitapivat
- Study type
- INTERVENTIONAL
- Phase
- Phase 3
- Registry status
- Active not recruiting
- Start
- 2021-11-30
- Completion
- 2029-06
- Enrolment
- 258
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionTransfusion-dependent Alpha-Thalassemia; Transfusion-dependent Beta-ThalassemiaInterventionPlacebo Matching Mitapivat; MitapivatPhasePhase 3Registry statusActive not recruitingA 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 · start 2021-01-06
Registered record
- Registry ID
- NCT04696393
- Conditions
- Healthy Volunteers
- Interventions
- Mitapivat tablet
- Study type
- INTERVENTIONAL
- Phase
- Phase 1
- Registry status
- Completed
- Start
- 2021-01-06
- Completion
- 2021-03-19
- Enrolment
- 26
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHealthy VolunteersInterventionMitapivat tabletPhasePhase 1Registry statusCompleted