| Drug Name |
Ivosidenib |
| Drug ID |
BADD_D02524 |
| Description |
Ivosidenib is a first in class isocitrate dehydrogenase-1 (IDH1) approved for use by the FDA in acute myeloid leukemia (AML) in July 2018 [L3768]. Ivosidenib is now available in the United States under the trade name Tibsovo marketed by Agios Pharmaceuticals, Inc. Ivosidenib has been granted fast track, priority review, and orphan drug designations by the FDA.
This approval came alongside the approval for the RealTime IDH1 Assay which is meant as a companion diagnostic tool to detect IDH1 mutations [L3768]. RealTime IDH1 Assay is marketed by Abbott Laboratories. |
| Indications and Usage |
Ivosidenib is approved for use in the treatment of relapsed or refractory AML with a susceptible IDH1 mutation as detected by an FDA-approved test [FDA Label]. |
| Marketing Status |
approved; investigational |
| ATC Code |
L01XX62 |
| DrugBank ID |
DB14568
|
| KEGG ID |
D11090
|
| MeSH ID |
C000627630
|
| PubChem ID |
71657455
|
| TTD Drug ID |
D07DCG
|
| NDC Product Code |
72694-617; 71334-100; 63285-800; 54864-720 |
| UNII |
Q2PCN8MAM6
|
| Synonyms |
ivosidenib | N-((1S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)-1-(4-cyano-2-pyridinyl)-N-(5-fluoro-3-pyridinyl)-5-oxo-L-prolinamide | AG-120 | Tibsovo |
