NDAORALTABLETPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Mechanism of Action
Isocitrate Dehydrogenase 1 Inhibitors
Pharmacologic Class:
Isocitrate Dehydrogenase 1 Inhibitor
Clinical Trials (4)
Ivosidenib and Azacitidine With or Without Venetoclax in Adult Patients With Newly Diagnosed IDH1-Mutated AML or MDS/AML Considered Ineligible for Intensive Chemotherapy
Started Aug 2025
227 enrolled
Acute Myeloid Leukemia
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
Started Jun 2023
36 enrolled
Acute Myeloid Leukemia (AML)
Ivosidenib (AG-120) With Nivolumab in IDH1 Mutant Tumors
Started Sep 2021
15 enrolled
Advanced Solid TumorIDH1 MutationGlioma
Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
Started Jan 2021
8 enrolled
Advanced CholangiocarcinomaMetastatic CholangiocarcinomaUnresectable Cholangiocarcinoma
Loss of Exclusivity
LOE Date
Jun 7, 2039
161 months away
Patent Expiry
Jun 7, 2039
Exclusivity Expiry
Oct 24, 2030
Company
R-Pharm US
NJ - Princeton