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vorasidenib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| isocitrate dehydrogenase inhibitors | 5829 | 1644545-52-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Vorasidenib is a small molecule inhibitor that targets isocitrate dehydrogenase-1 and 2 (IDH1 and IDH2) enzymes. In vitro, vorasidenib inhibited the IDH1 wild type and mutant variants, including R132H and the IDH2 wild type and mutant variants. In cell-based and in vivo tumor models expressing IDH1 or IDH2 mutated proteins, vorasidenib decreased production of 2-hydroxyglutarate (2-HG) and partially restored cellular differentiation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 6, 2024 | FDA | Servier | |
| Sept. 17, 2025 | EMA | Les Laboratoires Servier | |
| Sept. 19, 2025 | PMDA | Nihon Servier Co., Ltd. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XM04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Isocitrate dehydrogenase (IDH) inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
| FDA MoA | N0000193614 | Isocitrate Dehydrogenase 2 Inhibitors |
| FDA EPC | N0000193615 | Isocitrate Dehydrogenase 2 Inhibitor |
| FDA EPC | N0000193987 | Isocitrate Dehydrogenase 1 Inhibitor |
| FDA MoA | N0000193988 | Isocitrate Dehydrogenase 1 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
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 |
|---|---|---|---|
| Grade 2 astrocytoma | indication | 55353007 | DOID:3078 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 12433895 | July 11, 2034 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION FOLLOWING SURGERY, WHEREIN THE CANCER IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
| 40MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 12433895 | July 11, 2034 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION FOLLOWING SURGERY, WHEREIN THE CANCER IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
| 10MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 11844758 | Dec. 4, 2035 | A METHOD OF TREATING A GLIOMA CHARACTERIZED BY AN IDHI MUTATION FOLLOWING SURGERY, WHEREIN THE GLIOMA IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
| 40MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 11844758 | Dec. 4, 2035 | A METHOD OF TREATING A GLIOMA CHARACTERIZED BY AN IDHI MUTATION FOLLOWING SURGERY, WHEREIN THE GLIOMA IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
| 10MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 11345677 | Jan. 16, 2039 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 OR IDH2 MUTATION OR COMBINATION THEREOF FOLLOWING SURGERY, WHEREIN THE CANCER IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
| 40MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | 11345677 | Jan. 16, 2039 | A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 OR IDH2 MUTATION OR COMBINATION THEREOF FOLLOWING SURGERY, WHEREIN THE CANCER IS GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | Aug. 6, 2029 | NEW CHEMICAL ENTITY |
| 40MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | Aug. 6, 2029 | NEW CHEMICAL ENTITY |
| 10MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | Aug. 6, 2031 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) OR ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION FOLLOWING SURGERY INCLUDING BIOPSY, SUB-TOTAL RESECTION, OR GROSS TOTAL RESECTION |
| 40MG | VORANIGO | SERVIER | N218784 | Aug. 6, 2024 | RX | TABLET | ORAL | Aug. 6, 2031 | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH GRADE 2 ASTROCYTOMA OR OLIGODENDROGLIOMA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) OR ISOCITRATE DEHYDROGENASE-2 (IDH2) MUTATION FOLLOWING SURGERY INCLUDING BIOPSY, SUB-TOTAL RESECTION, OR GROSS TOTAL RESECTION |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Isocitrate dehydrogenase [NADP], mitochondrial | Enzyme | INHIBITOR | IC50 | 6.95 | DRUG LABEL | DRUG LABEL | |||
| Isocitrate dehydrogenase [NADP] cytoplasmic | Enzyme | INHIBITOR | IC50 | 7.69 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4279047 | ChEMBL_ID |
| C000716758 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB17097 | DRUGBANK_ID |
| 4043316 | VANDF |
| C4726974 | UMLSCUI |
| CHEBI:756658 | CHEBI |
| 9UO | PDB_CHEM_ID |
| CHEMBL4594378 | ChEMBL_ID |
| 10525 | INN_ID |
| 117817422 | PUBCHEM_CID |
| 388277 | MMSL |
| 43035 | MMSL |
| d10209 | MMSL |
| 10663 | IUPHAR_LIGAND_ID |
| 789Q85GA8P | UNII |
| 2690647 | RXNORM |
| 933316181000036101 | SNOMEDCT_US |
| D11834 | KEGG_DRUG |
| 019823 | NDDF |
| 019825 | NDDF |
| 789Q85GA8P | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VORANIGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72694-728 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 31 sections |
| VORANIGO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72694-879 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 31 sections |