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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 M. tuberculosis, MRSA and E. coli. 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.

  • Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.

    NCT07463768 · start 2026-09

    Registered record
    Registry ID
    NCT07463768
    Conditions
    Acute Myeloid Leukemia
    Interventions
    Ivosidenib + oral azacitidine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-09
    Completion
    2030-09
    Enrolment
    60

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

    ConditionAcute Myeloid Leukemia
    InterventionIvosidenib + oral azacitidine
    PhasePhase 2
    Registry statusNot yet recruiting
  • Ivosidenib Plus mFOLFOXIRI and Celecoxib for BRAF-targeted Therapy-refractory BRAF V600E-mutant Colorectal Cancer Patients

    NCT07809893 · start 2026-08-10

    Registered record
    Registry ID
    NCT07809893
    Conditions
    Colorectal Cancer
    Interventions
    Ivonescimab +mFOLFOXIRI +celecoxib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-08-10
    Completion
    2028-06-30
    Enrolment
    45

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

    ConditionColorectal Cancer
    InterventionIvonescimab +mFOLFOXIRI +celecoxib
    PhasePhase 2
    Registry statusRecruiting
  • Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients

    NCT07507760 · start 2026-06-12

    Registered record
    Registry ID
    NCT07507760
    Conditions
    Acute Myeloid Leukemia With Gene Mutations
    Interventions
    Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET; Ivosidenib Oral Tablet; Hydroxyurea; Cytarabine; Allogeneic stem cell transplantation
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-06-12
    Completion
    2029-04
    Enrolment
    50

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

    ConditionAcute Myeloid Leukemia With Gene Mutations
    InterventionDecitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET; Ivosidenib Oral Tablet; Hydroxyurea; Cytarabine +1 more
    PhasePhase 2
    Registry statusRecruiting
  • Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS

    NCT07607418 · start 2026-05-22

    Registered record
    Registry ID
    NCT07607418
    Conditions
    AML (Acute Myeloid Leukemia); MDS (Myelodysplastic Syndrome)
    Interventions
    Ivosidenib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-05-22
    Completion
    2027-12-30
    Enrolment
    20

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

    ConditionAML (Acute Myeloid Leukemia); MDS (Myelodysplastic Syndrome)
    InterventionIvosidenib
    PhasePhase 2
    Registry statusRecruiting
  • A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia

    NCT07392242 · start 2026-01-27

    Registered record
    Registry ID
    NCT07392242
    Conditions
    Acute Myeloid Leukemia
    Interventions
    Ivosidenib; Azacitidine; Venetoclax
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-01-27
    Completion
    2028-01
    Enrolment
    45

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

    ConditionAcute Myeloid Leukemia
    InterventionIvosidenib; Azacitidine; Venetoclax
    PhasePhase 2
    Registry statusRecruiting
  • Ivosidenib as Post-HSCT Maintenance for AML

    NCT06707493 · start 2026-01-16

    Registered record
    Registry ID
    NCT06707493
    Conditions
    IDH1 Mutation; Acute Myeloid Leukemia (AML); Hematopoietic Stem Cell Transplant (HSCT)
    Interventions
    Ivosidenib; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-01-16
    Completion
    2030-01-01
    Enrolment
    75

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

    ConditionIDH1 Mutation; Acute Myeloid Leukemia (AML); Hematopoietic Stem Cell Transplant (HSCT)
    InterventionIvosidenib; Placebo
    PhasePhase 2
    Registry statusRecruiting
  • A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment

    NCT07006688 · start 2026-01-14

    Registered record
    Registry ID
    NCT07006688
    Conditions
    IDH1-Mutated Malignancies
    Interventions
    Ivosidenib Oral Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2026-01-14
    Completion
    2028-08-31
    Enrolment
    30

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

    ConditionIDH1-Mutated Malignancies
    InterventionIvosidenib Oral Tablet
    PhasePhase 1
    Registry statusRecruiting
  • Repeatability of Magnetic Resonance Imaging in Patients With IDH1 Mutant Glioma on Ivosidenib

    NCT06648473 · start 2026-01-01

    Registered record
    Registry ID
    NCT06648473
    Conditions
    Low Grade Glioma of Brain
    Interventions
    MRI Scan
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Withdrawn
    Start
    2026-01-01
    Completion
    2027-12-01
    Enrolment
    0

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

    ConditionLow Grade Glioma of Brain
    InterventionMRI Scan
    PhaseNot applicable
    Registry statusWithdrawn
  • Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma

    NCT07260175 · start 2025-11-18

    Registered record
    Registry ID
    NCT07260175
    Conditions
    Cholangiocarcinoma; IDH Mutation
    Interventions
    Ivosidenib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-11-18
    Completion
    2031-12
    Enrolment
    40

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

    ConditionCholangiocarcinoma; IDH Mutation
    InterventionIvosidenib
    PhasePhase 2
    Registry statusRecruiting
  • Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML

    NCT06611839 · start 2025-10-17

    Registered record
    Registry ID
    NCT06611839
    Conditions
    AML; IDH1 Mutation; Treatment
    Interventions
    Ivosidenib, Venetoclax, Azacitidine
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2025-10-17
    Completion
    2028-10-01
    Enrolment
    23

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

    ConditionAML; IDH1 Mutation; Treatment
    InterventionIvosidenib, Venetoclax, Azacitidine
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

    NCT06717958 · start 2025-06-17

    Registered record
    Registry ID
    NCT06717958
    Conditions
    AML; MDS
    Interventions
    Ivosidenib 250 MG (milligram)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-06-17
    Completion
    2030-02-01
    Enrolment
    76

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

    ConditionAML; MDS
    InterventionIvosidenib 250 MG (milligram)
    PhasePhase 2
    Registry statusRecruiting
  • IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

    NCT06713837 · start 2025-02-27

    Registered record
    Registry ID
    NCT06713837
    Conditions
    Acute Myeloid Leukemia; Relapse/Recurrence
    Interventions
    High intensity therapies; Low intensity therapies
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2025-02-27
    Completion
    2028-01
    Enrolment
    339

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

    ConditionAcute Myeloid Leukemia; Relapse/Recurrence
    InterventionHigh intensity therapies; Low intensity therapies
    PhasePhase 3
    Registry statusRecruiting
  • Ivosidenib Plus Durvalumab and Gemcitabine/Cisplatin as First-Line Therapy in Participants With Locally Advanced or Metastatic Cholangiocarcinoma With an IDH1 Mutation

    NCT06501625 · start 2024-12-16

    Registered record
    Registry ID
    NCT06501625
    Conditions
    Locally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
    Interventions
    Ivosidenib; Durvalumab (for the first 8, 21-day, cycles); Gemcitabine (for the first 8, 21-day, cycles); Cisplatin (for the first 8, 21-day, cycles); Durvalumab (starting from cycle 9); Ivosidenib Recommended Combination Dose (RCD)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2024-12-16
    Completion
    2027-09-13
    Enrolment
    52

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

    ConditionLocally Advanced, Unresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
    InterventionIvosidenib; Durvalumab (for the first 8, 21-day, cycles); Gemcitabine (for the first 8, 21-day, cycles); Cisplatin (for the first 8, 21-day, cycles) +2 more
    PhasePhase 1 / Phase 2
    Registry statusRecruiting
  • Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer

    NCT06593548 · start 2024-11-01

    Registered record
    Registry ID
    NCT06593548
    Conditions
    CRC; MSS; Metastatic Cancer
    Interventions
    Ivosidenib (AK112)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2024-11-01
    Completion
    2026-11-01
    Enrolment
    36

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

    ConditionCRC; MSS; Metastatic Cancer
    InterventionIvosidenib (AK112)
    PhasePhase 2
    Registry statusNot yet recruiting
  • Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation

    NCT06291987 · start 2024-09-19

    Registered record
    Registry ID
    NCT06291987
    Conditions
    Myeloproliferative Neoplasms
    Interventions
    Ivosidenib; Ruxolitinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2024-09-19
    Completion
    2029-05
    Enrolment
    18

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

    ConditionMyeloproliferative Neoplasms
    InterventionIvosidenib; Ruxolitinib
    PhasePhase 1
    Registry statusRecruiting