Product Description
Olutasidenib is an orally available inhibitor of isocitrate dehydrogenase type 1 (IDH1; IDH-1; IDH1 [NADP+] soluble) with a mutation at arginine (R) 132, IDH1(R132), with potential antineoplastic activity. Upon administration, olutasidenib specifically inhibits IDH1(R132), thereby inhibiting the formation of the oncometabolite 2-hydroxyglutarate (2HG) from alpha-ketoglutarate (a-KG). This prevents 2HG-mediated signaling and leads to both an induction of cellular differentiation and an inhibition of cellular proliferation in tumor cells expressing IDH(R132). IDH1(R132) mutations are highly expressed in certain malignancies, including gliomas; they initiate and drive cancer growth by both blocking cell differentiation and catalyzing the formation of 2HG. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Olutasidenib)
Mechanisms of Action: IDH Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: United States
Approved Indications: None
Known Adverse Events: None
Company: Novo Nordisk
Company Location: BAGSVAERD DENMARK G7 00000
Company CEO: Lars Fruergaard Jorgensen
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, France, Germany, Italy, Korea, Netherlands, Spain, United Kingdom, United States
Active Clinical Trial Count: 5
Highest Development Phases
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Astrocytoma|Brain Cancer|Cholangiocarcinoma|Chondrosarcoma|Chronic Myelomonocytic Leukemia|Glioblastoma|Glioma|Hepatocellular Carcinoma|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Oligodendroglioma|Preleukemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
TarGeT-D | P2 |
Not yet recruiting |
Glioblastoma|Brain Cancer|Oligodendroglioma|Astrocytoma |
2029-06-01 |
57% |
NCI-2024-07045 | P2 |
Not yet recruiting |
Acute Myelomonocytic Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Acute Monocytic Leukemia |
2027-08-31 |
|
NCI-2024-04807 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2027-06-30 |
|
2102-HEM-101 | P2 |
Completed |
Myelodysplastic Syndrome|Preleukemia|Acute Myeloid Leukemia |
2023-12-28 |
57% |