Enasidenib
- Generic Name
- Enasidenib
- Brand Names
- Idhifa
- Drug Type
- Small Molecule
- Chemical Formula
- C19H17F6N7O
- CAS Number
- 1446502-11-9
- Unique Ingredient Identifier
- 3T1SS4E7AG
- Background
Enasidenib is an orally available treatment for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with specific mutations in the isocitrate dehydrogenase 2 (IDH2) gene, which is a recurrent mutation detected in 12-20% of adult patients with AML . Patients eligible for this treatment are selected by testing the presence of IDH2 mutations in the blood or bone marrow. This small molecule acts as an allosteric inhibitor of mutant IDH2 enzyme to prevent cell growth, and it also has shown to block several other enzymes that play a role in abnormal cell differentiation. First developed by Agios Pharmaceuticals and licensed to Celgene, enasidenib was approved by U.S. Food and Drug Administration on August 1, 2017.
- Indication
Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.
- Associated Conditions
- Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myelogenous Leukemia (AML)
A Study of Enasidenib in People With T-Cell Lymphoma
- First Posted Date
- 2025-01-02
- Last Posted Date
- 2025-01-02
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 25
- Registration Number
- NCT06756308
- Locations
- 🇺🇸
Dana Farber Cancer Institute (Data Collection Only), Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow Biopsy
- First Posted Date
- 2024-11-04
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 93
- Registration Number
- NCT06672146
- Locations
- 🇺🇸
Augusta University Medical Center, Augusta, Georgia, United States
🇺🇸Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial)
- Conditions
- Myelodysplastic Syndrome
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow Biopsy
- First Posted Date
- 2024-08-29
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 54
- Registration Number
- NCT06577441
- Locations
- 🇺🇸
Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho, United States
🇺🇸Kootenai Clinic Cancer Services - Post Falls, Post Falls, Idaho, United States
🇺🇸Kootenai Clinic Cancer Services - Sandpoint, Sandpoint, Idaho, United States
Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial
- Conditions
- Clonal Cytopenia of Undetermined SignificanceCCUS Clonal Cytopenia of Undetermined Significance
- Interventions
- First Posted Date
- 2024-02-05
- Last Posted Date
- 2025-02-14
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 15
- Registration Number
- NCT06240754
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
Enasidenib in IDH2-Mutated Malignant Sinonasal and Skull Base Tumors
- Conditions
- Locally Advanced ChondrosarcomaLocally Advanced Sinonasal AdenocarcinomaMetastatic Olfactory NeuroblastomaLocally Advanced Olfactory NeuroblastomaMetastatic Sinonasal Undifferentiated CarcinomaMetastatic Sinonasal AdenocarcinomaLocally Advanced Large-cell Neuroendocrine CarcinomaMetastatic ChondrosarcomaLocally Advanced Sinonasal Undifferentiated CarcinomaMetastatic Large-cell Neuroendocrine Carcinoma
- Interventions
- First Posted Date
- 2023-12-20
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 40
- Registration Number
- NCT06176989
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- First Posted Date
- 2023-03-06
- Last Posted Date
- 2025-03-05
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 36
- Registration Number
- NCT05756777
- Locations
- 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
- Conditions
- Myelodysplastic SyndromeAcute Myeloid Leukemia
- Interventions
- Procedure: Biospecimen CollectionOther: Best PracticeProcedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Bone Marrow AspirationProcedure: Biopsy ProcedureProcedure: Mutation Carrier ScreeningProcedure: Bone Marrow BiopsyProcedure: Echocardiography TestProcedure: Multigated Acquisition ScanDrug: Liposome-encapsulated Daunorubicin-CytarabineProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Positron Emission TomographyDrug: Placebo AdministrationRadiation: Total-Body Irradiation
- First Posted Date
- 2022-10-03
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 2000
- Registration Number
- NCT05564390
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸Mercy Hospital South, Saint Louis, Missouri, United States
🇺🇸Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
- Conditions
- Recurrent Acute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2022-07-01
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 15
- Registration Number
- NCT05441514
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
IDH Targeted/Non- Targeted vs Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)
- Conditions
- Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2022-06-02
- Last Posted Date
- 2025-05-14
- Lead Sponsor
- Alice Mims
- Target Recruit Count
- 125
- Registration Number
- NCT05401097
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Enasidenib in MDS &Non-proliferative Chronic Myelomonocytic Leukemia w/o IDH2 Mutation
- Conditions
- LeukemiaLeukemia, MyeloidMonocytic Leukemia
- Interventions
- First Posted Date
- 2022-03-16
- Last Posted Date
- 2025-03-20
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 17
- Registration Number
- NCT05282459
- Locations
- 🇺🇸
Stanford Cancer Institute, Palo Alto, California, United States
Drug Development Updates
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