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Olutasidenib

Alternative Names: olutasidenib, ft-2102, ft2102, ft 2102, Rezlidhia
Latest Update: 2025-04-03
Latest Update Note: Clinical Trial Update

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
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Olutasidenib

Countries in Clinic: Australia, Canada, France, Germany, Italy, Korea, Netherlands, Spain, United Kingdom, United States

Active Clinical Trial Count: 6

Highest Development Phases

Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Astrocytoma|Brain Cancer|Chronic Myelomonocytic Leukemia|Glioblastoma|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Myeloproliferative Disorders|Oligodendroglioma|Oncology Unspecified|Preleukemia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

TarGeT-D

P2

Recruiting

Astrocytoma|Oligodendroglioma|Brain Cancer|Glioblastoma

2029-06-01

OLUVENAZA

P2

Not yet recruiting

Acute Myeloid Leukemia

2028-06-01

NCI-2024-07758

P2

Recruiting

Chronic Myelomonocytic Leukemia|Acute Monocytic Leukemia|Myeloproliferative Disorders|Acute Myelomonocytic Leukemia|Preleukemia|Myelodysplastic Syndrome|Juvenile Myelomonocytic Leukemia,

2027-08-31

NCI-2024-07045

P2

Recruiting

Chronic Myelomonocytic Leukemia|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Myelodysplastic Syndrome|Juvenile Myelomonocytic Leukemia,

2027-08-31

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