Olutasidenib

Overview

Olutasidenib (FT-2102) is a selective and potent isocitrate dehydrogenase-1 (IDH1) inhibitor approved by the FDA in December 2022. It is indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) in patients with a susceptible IDH1 mutation as determined by an FDA-approved test. IDH1 mutations are common in different types of cancer, such as gliomas, AML, intrahepatic cholangiocarcinoma, chondrosarcoma, and myelodysplastic syndromes (MDS), and they lead to an increase in 2-hydroxyglutarate (2-HG), a metabolite that participates in tumerogenesis. Olutasidenib inhibits the mutated IDH1 specifically, and provides a therapeutic benefit in IDH1-mutated cancers. Other IDH1 inhibitors, such as ivosidenib, have also been approved for the treatment of relapsed or refractory AML. Olutasidenib is orally bioavailable and capable of penetrating the blood-brain barrier, and is also being evaluated for the treatment of myelodysplastic syndrome (MDS), as well as solid tumors and gliomas (NCT03684811).

Indication

Olutasidenib is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

Associated Conditions

Refractory Acute Myeloid Leukemia (AML)
Relapsed Acute Myelogenous Leukemia (AML)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations	2025/06/24	NCT07032727	Phase 2	Not yet recruiting	M.D. Anderson Cancer Center
Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy	2025/01/20	NCT06782542	Phase 2	Recruiting	Justin Watts, MD
A Phase II Open-label Study of Olutasidenib Post-transplant Maintenance Therapy for Patients With IDH1-mutated Myeloid Malignancies	2024/10/31	NCT06668584	Phase 2	Recruiting	M.D. Anderson Cancer Center
A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm	2024/09/19	NCT06597734	Phase 2	Recruiting	M.D. Anderson Cancer Center
A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.	2024/08/22	NCT06566742	Phase 2	Recruiting	M.D. Anderson Cancer Center
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant	2024/08/09	NCT06543381	Phase 1	Recruiting	City of Hope Medical Center
Phase 1b/2 Study of Decitabine and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Olutasidenib	2024/06/06	NCT06445959	Phase 1	Recruiting	M.D. Anderson Cancer Center
Study of Olutasidenib and Temozolomide in HGG	2023/12/08	NCT06161974	Phase 2	Recruiting	Rigel Pharmaceuticals
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation	2018/09/26	NCT03684811	Phase 1	Completed	Forma Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
REZLIDHIA	Rigel Pharmaceuticals, Inc.	71332-005	ORAL	150 mg in 1 1	12/8/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Olutasidenib Maintenance Therapy Demonstrates Sustained Remission in IDH1-Mutated AML Patients

a month ago

Olutasidenib maintenance therapy achieved an 83% relapse-free survival rate at 4 months and 71% at 12 months in IDH1-mutated AML patients who achieved complete remission following induction therapy.

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