Ivosidenib

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

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

Chemical structure

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.

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.

Open Ivosidenib in ChEMBL Registered studies below

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.

Condition

Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia
NCT04250051 · start 2020-12-21
Registered record
Registry ID
NCT04250051
Conditions
Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Recurrent Myeloproliferative Neoplasm; Refractory Acute Myeloid Leukemia; Refractory Myelodysplastic Syndrome; Newly Diagnosed Acute Myeloid Leukemia (AML); IDH1 Mutation Myeloid Neoplasms; Acute Myeloid Leukemia (AML)
Interventions
Cytarabine; Filgrastim; Fludarabine; Fludarabine Phosphate; Ivosidenib; Idarubicin
Study type
INTERVENTIONAL
Phase
Phase 1
Registry status
Terminated
Start
2020-12-21
Completion
2022-12-20
Enrolment
2
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionRecurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome; Recurrent Myeloproliferative Neoplasm; Refractory Acute Myeloid Leukemia +4 more
InterventionCytarabine; Filgrastim; Fludarabine; Fludarabine Phosphate +2 more
PhasePhase 1
Registry statusTerminated
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
NCT04603001 · start 2020-11-19
Registered record
Registry ID
NCT04603001
Conditions
Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS); Chronic Myelomonocytic Leukemia (CMML); Myeloproliferative Neoplasms (MPNs)
Interventions
LY3410738; Venetoclax; Azacitidine
Study type
INTERVENTIONAL
Phase
Phase 1
Registry status
Active not recruiting
Start
2020-11-19
Completion
2027-05
Enrolment
260
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAcute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS); Chronic Myelomonocytic Leukemia (CMML); Myeloproliferative Neoplasms (MPNs)
InterventionLY3410738; Venetoclax; Azacitidine
PhasePhase 1
Registry statusActive not recruiting
Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)
NCT04195555 · start 2020-07-20
Registered record
Registry ID
NCT04195555
Conditions
Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Recurrent WHO Grade 2 Glioma; Refractory Ependymoma; Refractory Ewing Sarcoma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma; Refractory WHO Grade 2 Glioma
Interventions
Ivosidenib
Study type
INTERVENTIONAL
Phase
Phase 2
Registry status
Active not recruiting
Start
2020-07-20
Completion
2027-05-09
Enrolment
3
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionRecurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis +28 more
InterventionIvosidenib
PhasePhase 2
Registry statusActive not recruiting
A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS
NCT04044209 · start 2020-02-12
Registered record
Registry ID
NCT04044209
Conditions
Myelodysplastic Syndromes; Acute Myeloid Leukemia
Interventions
AG-120; Nivolumab
Study type
INTERVENTIONAL
Phase
Phase 2
Registry status
Withdrawn
Start
2020-02-12
Completion
2023-09
Enrolment
0
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionMyelodysplastic Syndromes; Acute Myeloid Leukemia
InterventionAG-120; Nivolumab
PhasePhase 2
Registry statusWithdrawn
IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome
NCT03503409 · start 2019-05-14
Registered record
Registry ID
NCT03503409
Conditions
Myelodysplastic Syndromes; Acute Myeloid Leukemia
Interventions
AG-120
Study type
INTERVENTIONAL
Phase
Phase 2
Registry status
Active not recruiting
Start
2019-05-14
Completion
2027-04-02
Enrolment
68
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionMyelodysplastic Syndromes; Acute Myeloid Leukemia
InterventionAG-120
PhasePhase 2
Registry statusActive not recruiting
A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy
NCT03839771 · start 2019-03-01
Registered record
Registry ID
NCT03839771
Conditions
Acute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2
Interventions
AG-120; Placebo for AG-120; AG-221; Placebo for AG-221
Study type
INTERVENTIONAL
Phase
Phase 3
Registry status
Active not recruiting
Start
2019-03-01
Completion
2034-09-19
Enrolment
968
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAcute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts-2
InterventionAG-120; Placebo for AG-120; AG-221; Placebo for AG-221
PhasePhase 3
Registry statusActive not recruiting
Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
NCT03680677 · start 2018-09-21
Registered record
Registry ID
NCT03680677
Conditions
Leukemia, Acute; MDS
Interventions
Bone Marrow or Peripheral Blood Graft (BMT); Cancer-directed Therapy or Best Supportive Care; Frailty Assessment
Study type
OBSERVATIONAL
Phase
Not recorded
Registry status
Recruiting
Start
2018-09-21
Completion
2027-11
Enrolment
20
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionLeukemia, Acute; MDS
InterventionBone Marrow or Peripheral Blood Graft (BMT); Cancer-directed Therapy or Best Supportive Care; Frailty Assessment
PhaseNot recorded
Registry statusRecruiting
A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site
NCT03498521 · start 2018-07-10
Registered record
Registry ID
NCT03498521
Conditions
Cancer of Unknown Primary Site
Interventions
Alectinib; Vismodegib; Ipatasertib; Olaparib; Erlotinib; Bevacizumab; Vemurafenib; Cobimetinib; Trastuzumab Subcutaneous (SC); Pertuzumab; Atezolizumab; Carboplatin; Paclitaxel; Cisplatin; Gemcitabine; Entrectinib; Ivosidenib; Pemigatinib
Study type
INTERVENTIONAL
Phase
Phase 2
Registry status
Completed
Start
2018-07-10
Completion
2024-11-07
Enrolment
529
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionCancer of Unknown Primary Site
InterventionAlectinib; Vismodegib; Ipatasertib; Olaparib +14 more
PhasePhase 2
Registry statusCompleted
Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies
NCT03471260 · start 2018-03-19
Registered record
Registry ID
NCT03471260
Conditions
Acute Myeloid Leukemia; Hematopoietic and Lymphoid System Neoplasm; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Interventions
Azacitidine; Ivosidenib; Venetoclax
Study type
INTERVENTIONAL
Phase
Phase 1 / Phase 2
Registry status
Recruiting
Start
2018-03-19
Completion
2027-09-30
Enrolment
96
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAcute Myeloid Leukemia; Hematopoietic and Lymphoid System Neoplasm; Myelodysplastic Syndrome; Myeloproliferative Neoplasm +2 more
InterventionAzacitidine; Ivosidenib; Venetoclax
PhasePhase 1 / Phase 2
Registry statusRecruiting
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
NCT03282513 · start 2017-09-26
Registered record
Registry ID
NCT03282513
Conditions
Hepatic Impairment
Interventions
AG-120 (Ivosidenib)
Study type
INTERVENTIONAL
Phase
Phase 1
Registry status
Completed
Start
2017-09-26
Completion
2018-03-31
Enrolment
33
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHepatic Impairment
InterventionAG-120 (Ivosidenib)
PhasePhase 1
Registry statusCompleted
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
NCT03155620 · start 2017-07-31
Registered record
Registry ID
NCT03155620
Conditions
Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphom
Interventions
Biopsy Procedure; Biospecimen Collection; Bone Marrow Aspiration and Biopsy; Bone Scan; Computed Tomography; Ensartinib; Erdafitinib; Ivosidenib; Laboratory Biomarker Analysis; Larotrectinib Sulfate; Magnetic Resonance Imaging; Mutation Carrier Screening; Olaparib; Palbociclib; Pharmacological Study; Positron Emission Tomography; Radionuclide Imaging; Samotolisib; Selpercatinib; Selumetinib Sulfate; Tazemetostat; Tipifarnib; Ulixertinib; Vemurafenib; X-Ray Imaging
Study type
INTERVENTIONAL
Phase
Phase 2
Registry status
Active not recruiting
Start
2017-07-31
Completion
2027-01-06
Enrolment
1,377
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAdvanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma +28 more
InterventionBiopsy Procedure; Biospecimen Collection; Bone Marrow Aspiration and Biopsy; Bone Scan +21 more
PhasePhase 2
Registry statusActive not recruiting
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
NCT03173248 · start 2017-06-26
Registered record
Registry ID
NCT03173248
Conditions
Newly Diagnosed Acute Myeloid Leukemia (AML); Untreated AML; AML Arising From Myelodysplastic Syndrome (MDS); Leukemia, Myeloid, Acute
Interventions
AG-120; Placebo; Azacitidine
Study type
INTERVENTIONAL
Phase
Phase 3
Registry status
Active not recruiting
Start
2017-06-26
Completion
2026-06-30
Enrolment
146
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionNewly Diagnosed Acute Myeloid Leukemia (AML); Untreated AML; AML Arising From Myelodysplastic Syndrome (MDS); Leukemia, Myeloid, Acute
InterventionAG-120; Placebo; Azacitidine
PhasePhase 3
Registry statusActive not recruiting
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
NCT03071770 · start 2017-03-31
Registered record
Registry ID
NCT03071770
Conditions
Healthy
Interventions
ivosidenib (AG-120)
Study type
INTERVENTIONAL
Phase
Phase 1
Registry status
Completed
Start
2017-03-31
Completion
2017-09-06
Enrolment
60
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionHealthy
Interventionivosidenib (AG-120)
PhasePhase 1
Registry statusCompleted
Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
NCT03013998 · start 2016-11
Registered record
Registry ID
NCT03013998
Conditions
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Interventions
Samalizumab (BAML-16-001-S1); BI 836858 (BAML-16-001-S2); Laboratory Biomarker Analysis; Daunorubicin (BAML-16-001-S1); Cytarabine (BAML-16-001-S1); Azacitidine (BAML-16-001-S2); AG-221 (BAML-16-001-S3); Azacitidine (BAML-16-001-S3); Entospletinib (BAML-16-001-S4); Azacitidine (BAML-16-001-S4); Entospletinib (BAML-16-001-S5); Decitabine (BAML-16-001-S5); Entospletinib (BAML-16-001-S6); Daunorubicin (BAML-16-001-S6); Cytarabine (BAML-16-001-S6); Pevonedistat (BAML-16-001-S9); Azacitidine (BAML-16-001-S9); AG-120 (BAML-16-001-S16); Azacitidine (BAML-16-001-S16); Gilteritinib (BAML-16-001-S8 Group 1); Decitabine (BAML-16-001-S8 Group 1); AZD5153 (BAML-16-001-S10); Venetoclax (BAML-16-001-S10); TP-0903 (BAML-16-001-S14); Decitabine (BAML-16-001-S14); Decitabine (BAML-16-001-S8 Group 2); Venetoclax (BAML-16-001-S8 Group 2); AZD5991 (BAML-16-001-S18); Azacitidine (BAML-16-001-S18); SNDX-5613 (BAML-16-001-S17); Azacitidine (BAML-16-001-S17); Venetoclax (BAML-16-001-S17); Gilteritinib (BAML-16
Study type
INTERVENTIONAL
Phase
Phase 2 / Phase 3
Registry status
Recruiting
Start
2016-11
Completion
2032-12
Enrolment
3,000
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionPreviously Untreated Relapsed Refractory Acute Myeloid Leukemia
InterventionSamalizumab (BAML-16-001-S1); BI 836858 (BAML-16-001-S2); Laboratory Biomarker Analysis; Daunorubicin (BAML-16-001-S1) +29 more
PhasePhase 2 / Phase 3
Registry statusRecruiting
Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
NCT02665065 · start 2016-06
Registered record
Registry ID
NCT02665065
Conditions
Acute Myeloid Leukemia; Leukemia, Acute Myeloid; Myeloid Leukemia, Acute; Leukemia, Myeloid, Acute; Acute Myelogenous Leukemia; Leukemia, Acute Myelogenous; Myelogenous Leukemia, Acute; AML; Bone Marrow Transplant
Interventions
Iomab-B; Conventional Care; HCT
Study type
INTERVENTIONAL
Phase
Phase 3
Registry status
Active not recruiting
Start
2016-06
Completion
2026-12
Enrolment
153
As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.
ConditionAcute Myeloid Leukemia; Leukemia, Acute Myeloid; Myeloid Leukemia, Acute; Leukemia, Myeloid, Acute +5 more
InterventionIomab-B; Conventional Care; HCT
PhasePhase 3
Registry statusActive not recruiting

Existing / approved use

Repurposing investigation

AI-predicted activity

Evidence

Clinical and experimental

Docking

Other medicines to investigate

Registered studies