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ivosidenib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| isocitrate dehydrogenase inhibitors | 5292 | 1448347-49-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ivosidenib is a small molecule inhibitor that targets the mutant isocitrate dehydrogenase 1 (IDH1) enzyme. Susceptible IDH1 mutations are defined as those leading to increased levels of 2-hydroxyglutarate(2-HG) in the leukemia cells and where efficacy is predicted by 1) clinically meaningful remissions with the recommended dose of ivosidenib and/or 2) inhibition of mutant IDH1 enzymatic activity at concentrations of ivosidenib sustainable at the recommended dosage according to validated methods. The most common of such mutations are R132H and R132C substitutions.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.04 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | GRK2,PDK1,PDK2,PDK4 | 4 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 20, 2018 | FDA | AGIOS PHARMS INC | |
| May 4, 2023 | EMA | LES LABORATOIRES SERVIER |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Differentiation syndrome | 140.48 | 55.78 | 18 | 175 | 1313 | 90626941 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Differentiation syndrome | 164.19 | 48.88 | 24 | 210 | 1789 | 42619312 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Differentiation syndrome | 275.03 | 55.71 | 39 | 432 | 3005 | 110585823 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XM02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Isocitrate dehydrogenase (IDH) inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000185506 | Cytochrome P450 3A4 Inducers |
| FDA MoA | N0000185507 | Cytochrome P450 2C9 Inducers |
| FDA EPC | N0000193987 | Isocitrate Dehydrogenase 1 Inhibitor |
| FDA MoA | N0000193988 | Isocitrate Dehydrogenase 1 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:145410 | EC 1.1.1.42 (isocitrate dehydrogenase) inhibitor |
Related Drugs by ATC class:
L01XM Isocitrate dehydrogenase (IDH) inhibitors 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute myeloid leukemia, disease | indication | 91861009 | |
| Biliary tract cancer | indication | 312104005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.43 | acidic |
| pKa2 | 0.21 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10610125 | June 21, 2030 | A METHOD FOR TREATING NEWLY DIAGNOSED AML WITH IVOSIDENIB AND AZACITIDINE WHEREIN THE AML HAS AN IDH1 MUTATION CAPABLE OF CONVERTING ALPHA-KETOGLUTARATE TO 2-HYDROXYGLUTARATE (2HG) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10610125 | June 21, 2030 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10610125 | June 21, 2030 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10717764 | Jan. 18, 2033 | A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY AN IDH1 MUTATION |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 11667673 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9850277 | Jan. 18, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9474779 | Aug. 19, 2033 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10799490 | March 13, 2035 | A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10799490 | March 13, 2035 | A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND THE AML IS NEWLY DIAGNOSED |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10799490 | March 13, 2035 | A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND WHERE THE AML IS RELAPSED/REFRACTORY |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9968595 | March 13, 2035 | A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9968595 | March 13, 2035 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9968595 | March 13, 2035 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 9968595 | March 13, 2035 | TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10653710 | Oct. 18, 2036 | A METHOD FOR TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 SELECTED FROM R132H, R132C, R132L, R132V, R132S AND R132GF BY ADMINISTERING IVOSIDENIB AND AZACITIDINE |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10980788 | June 7, 2039 | A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10980788 | June 7, 2039 | A METHOD OF TREATING RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10980788 | June 7, 2039 | TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10980788 | June 7, 2039 | TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | 10980788 | June 7, 2039 | TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | May 2, 2026 | TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULT PTS WHO ARE >=75 YRS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | Oct. 24, 2026 | FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES (MDS) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | Aug. 25, 2028 | TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
| 250MG | TIBSOVO | SERVIER | N211192 | July 20, 2018 | RX | TABLET | ORAL | Oct. 24, 2030 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MYELODYSPLASTIC SYNDROMES (MDS) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Isocitrate dehydrogenase [NADP] cytoplasmic | Enzyme | INHIBITOR | IC50 | 7.15 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Isocitrate dehydrogenase [NADP], mitochondrial | Enzyme | IC50 | 5.14 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| Q2PCN8MAM6 | UNII |
| 4037715 | VANDF |
| C4682397 | UMLSCUI |
| CHEBI:145430 | CHEBI |
| IV3 | PDB_CHEM_ID |
| CHEMBL3989958 | ChEMBL_ID |
| 71657455 | PUBCHEM_CID |
| DB14568 | DRUGBANK_ID |
| D11090 | KEGG_DRUG |
| 10225 | INN_ID |
| C000627630 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9217 | IUPHAR_LIGAND_ID |
| 773137008 | SNOMEDCT_US |
| 773232006 | SNOMEDCT_US |
| 285271 | MMSL |
| 34590 | MMSL |
| d08845 | MMSL |
| 017647 | NDDF |
| 2049873 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TIBSOVO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72694-617 | TABLET, FILM COATED | 250 mg | ORAL | NDA | 31 sections |