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Ivosidenib

FDA-approved product (tablet, oral), marketed as Tibsovo.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
3 of 4

Chemical structure

Chemical structure of Ivosidenib
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Acute myeloid leukemia
  • Cholangiocarcinoma

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Isocitrate dehydrogenase (idh) inhibitors
FDA pharmacologic class
Isocitrate Dehydrogenase 1 Inhibitor 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 E. coli, MRSA and M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA58.2% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli50.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae34.9% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis56.8% 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 evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

AutoDock 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 measured

Other repurposing candidates: approved medicines besides Ivosidenib 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.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Personalized Medicine for Advanced Biliary Cancer Patients

    NCT05615818 · start 2024-07-18

    Registered record
    Registry ID
    NCT05615818
    Conditions
    Biliary Tract Neoplasms
    Interventions
    Futibatinib; Ivosidenib; Zanidatamab; Trastuzumab; Neratinib; Encorafenib; Binimetinib; Niraparib; Cisplatin; Gemcitabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-07-18
    Completion
    2028-06
    Enrolment
    800

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiliary Tract Neoplasms
    InterventionFutibatinib; Ivosidenib; Zanidatamab; Trastuzumab +6 more
    PhasePhase 3
    Registry statusRecruiting
  • Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

    NCT06127407 · start 2024-07-09

    Registered record
    Registry ID
    NCT06127407
    Conditions
    Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
    Interventions
    Ivosidenib 500mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-07-09
    Completion
    2030-11-26
    Enrolment
    136

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLocally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
    InterventionIvosidenib 500mg; Placebo
    PhasePhase 3
    Registry statusRecruiting
  • MRD-positive AML Clinical Study

    NCT07131059 · start 2024-05-11

    Registered record
    Registry ID
    NCT07131059
    Conditions
    AML, Adult
    Interventions
    Ivosidenib; Gilteritinib; Venetoclax; Avapritinib; Daunorubicin; Cytarabine; Idarubicin; Mitoxantrone; Homoharringtonine; Azacitidine; Ruxolitinib; Trametinib
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Recruiting
    Start
    2024-05-11
    Completion
    2028-10-30
    Enrolment
    537

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAML, Adult
    InterventionIvosidenib; Gilteritinib; Venetoclax; Avapritinib +8 more
    PhaseNot applicable
    Registry statusRecruiting
  • An Exploratory Study on the Use of Ivosidenib for the Precise Treatment of Advanced Biliary Tract Malignancies With IDH1 Mutations in the Later Line of Therapy.

    NCT07282262 · start 2024-05-01

    Registered record
    Registry ID
    NCT07282262
    Conditions
    Biliary Tract Cancer
    Interventions
    Ivosidenib; Lenvatinib; PD-1/PD-L1 inhibitor
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-05-01
    Completion
    2026-10-01
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiliary Tract Cancer
    InterventionIvosidenib; Lenvatinib; PD-1/PD-L1 inhibitor
    PhasePhase 2
    Registry statusRecruiting
  • Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC

    NCT06181734 · start 2023-12-20

    Registered record
    Registry ID
    NCT06181734
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Ivosidenib
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2023-12-20
    Completion
    2025-07-30
    Enrolment
    8

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia (AML)
    InterventionIvosidenib
    PhaseNot recorded
    Registry statusCompleted
  • A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

    NCT05756777 · start 2023-10-25

    Registered record
    Registry ID
    NCT05756777
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Gilteritinib; Ivosidenib; Enasidenib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2023-10-25
    Completion
    2027-04-21
    Enrolment
    18

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia (AML)
    InterventionGilteritinib; Ivosidenib; Enasidenib
    PhasePhase 1
    Registry statusRecruiting
  • Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma

    NCT05921760 · start 2023-10-23

    Registered record
    Registry ID
    NCT05921760
    Conditions
    IDH1-mutant Cholangiocarcinoma
    Interventions
    Ivosidenib; Nivolumab; Ipilimumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2023-10-23
    Completion
    2024-11-21
    Enrolment
    7

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionIDH1-mutant Cholangiocarcinoma
    InterventionIvosidenib; Nivolumab; Ipilimumab
    PhasePhase 1 / Phase 2
    Registry statusTerminated
  • IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)

    NCT05401097 · start 2022-09-13

    Registered record
    Registry ID
    NCT05401097
    Conditions
    Acute Myeloid Leukemia
    Interventions
    Azacitidine; Biopsy; Enasidenib; Ivosidenib; Venetoclax
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2022-09-13
    Completion
    2029-06-30
    Enrolment
    125

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia
    InterventionAzacitidine; Biopsy; Enasidenib; Ivosidenib +1 more
    PhasePhase 2
    Registry statusRecruiting
  • Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

    NCT05209074 · start 2022-09-08

    Registered record
    Registry ID
    NCT05209074
    Conditions
    Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Cancer
    Interventions
    Ivosidenib; mFOLFIRINOX
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2022-09-08
    Completion
    2026-12-31
    Enrolment
    16

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPancreatic Ductal Adenocarcinoma; Resectable Pancreatic Cancer
    InterventionIvosidenib; mFOLFIRINOX
    PhasePhase 1
    Registry statusActive not recruiting
  • Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

    NCT04655391 · start 2022-06-25

    Registered record
    Registry ID
    NCT04655391
    Conditions
    Recurrent Acute Myeloid Leukemia
    Interventions
    Bosutinib Monohydrate; Decitabine; Enasidenib Mesylate; Gilteritinib Fumarate; Glasdegib Maleate; Ivosidenib; Venetoclax
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Withdrawn
    Start
    2022-06-25
    Completion
    2023-12-15
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionRecurrent Acute Myeloid Leukemia
    InterventionBosutinib Monohydrate; Decitabine; Enasidenib Mesylate; Gilteritinib Fumarate +3 more
    PhasePhase 1
    Registry statusWithdrawn
  • Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)

    NCT04777916 · start 2022-04-14

    Registered record
    Registry ID
    NCT04777916
    Conditions
    Acute Myeloid Leukemia (AML)
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2022-04-14
    Completion
    2046-04-01
    Enrolment
    5,000

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia (AML)
    InterventionNot recorded
    PhaseNot recorded
    Registry statusRecruiting
  • Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1

    NCT05030441 · start 2022-04-01

    Registered record
    Registry ID
    NCT05030441
    Conditions
    Clonal Cytopenia of Undetermined Significance
    Interventions
    Ivosidenib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-04-01
    Completion
    2030-01-31
    Enrolment
    20

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionClonal Cytopenia of Undetermined Significance
    InterventionIvosidenib
    PhasePhase 2
    Registry statusActive not recruiting
  • Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

    NCT04774393 · start 2021-05-24

    Registered record
    Registry ID
    NCT04774393
    Conditions
    Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
    Interventions
    Decitabine and Cedazuridine; Enasidenib; Ivosidenib; Venetoclax
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2021-05-24
    Completion
    2027-11-29
    Enrolment
    84

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
    InterventionDecitabine and Cedazuridine; Enasidenib; Ivosidenib; Venetoclax
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma

    NCT04088188 · start 2021-01-25

    Registered record
    Registry ID
    NCT04088188
    Conditions
    Advanced Cholangiocarcinoma; Metastatic Cholangiocarcinoma; Unresectable Cholangiocarcinoma
    Interventions
    Cisplatin; Gemcitabine; Ivosidenib; Pemigatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2021-01-25
    Completion
    2023-12-01
    Enrolment
    8

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdvanced Cholangiocarcinoma; Metastatic Cholangiocarcinoma; Unresectable Cholangiocarcinoma
    InterventionCisplatin; Gemcitabine; Ivosidenib; Pemigatinib
    PhasePhase 1
    Registry statusTerminated
  • CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

    NCT04493164 · start 2020-12-30

    Registered record
    Registry ID
    NCT04493164
    Conditions
    Acute Myeloid Leukemia With Gene Mutations; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
    Interventions
    Ivosidenib; Liposome-encapsulated Daunorubicin-Cytarabine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2020-12-30
    Completion
    2028-06-01
    Enrolment
    30

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAcute Myeloid Leukemia With Gene Mutations; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Recurrent Acute Myeloid Leukemia +1 more
    InterventionIvosidenib; Liposome-encapsulated Daunorubicin-Cytarabine
    PhasePhase 2
    Registry statusRecruiting