MedPath

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)
Clinical Trials
Related News

Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

Phase 1
Terminated
Conditions
Acute Myeloid Leukemia
Relapsed Cancer
Refractory Cancer
IDH2 Gene Mutation
Interventions
First Posted Date
2019-09-17
Last Posted Date
2024-01-24
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
27
Registration Number
NCT04092179
Locations
πŸ‡¨πŸ‡¦

University of Alberta Hospital, Edmonton, Alberta, Canada

πŸ‡¨πŸ‡¦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2019-09-03
Last Posted Date
2023-10-16
Lead Sponsor
Jazz Pharmaceuticals
Target Recruit Count
57
Registration Number
NCT04075747
Locations
πŸ‡ΊπŸ‡Έ

University of Kansas Cancer Center, Fairway, Kansas, United States

πŸ‡ΊπŸ‡Έ

University of Nebraska Medical Center, Omaha, Nebraska, United States

πŸ‡ΊπŸ‡Έ

Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 7 locations

Enasidenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia With an IDH2 Gene Mutation

Phase 2
Withdrawn
Conditions
Bone Marrow Blasts Decreased by 50 Percent or More Compared to Pretreatment Level
Blasts Under 5 Percent of Peripheral Blood White Cells
IDH2 Gene Mutation
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Interventions
Procedure: Hematopoietic Cell Transplantation
First Posted Date
2019-03-19
Last Posted Date
2021-03-10
Lead Sponsor
Roswell Park Cancer Institute
Registration Number
NCT03881735
Locations
πŸ‡ΊπŸ‡Έ

Roswell Park Cancer Institute, Buffalo, New York, United States

πŸ‡ΊπŸ‡Έ

Cancer Institute at St Francis Hosptial, East Hills, New York, United States

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1
Terminated
Conditions
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma
Interventions
Biological: Bevacizumab
Procedure: Biospecimen Collection
Biological: Durvalumab
Biological: Ipilimumab
Biological: Nivolumab
Biological: Pembrolizumab
Biological: Pertuzumab
Other: Quality-of-Life Assessment
Biological: Trastuzumab Emtansine
First Posted Date
2019-03-18
Last Posted Date
2024-03-04
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
2
Registration Number
NCT03878524
Locations
πŸ‡ΊπŸ‡Έ

OHSU Knight Cancer Institute, Portland, Oregon, United States

CPX-351 Plus Enasidenib for Relapsed AML

Phase 2
Active, not recruiting
Conditions
Recurrent Acute Myeloid Leukemia
Interventions
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
First Posted Date
2019-01-31
Last Posted Date
2023-09-28
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
2
Registration Number
NCT03825796
Locations
πŸ‡ΊπŸ‡Έ

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

πŸ‡ΊπŸ‡Έ

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

University of California San Diego, San Diego, California, United States

Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2018-11-02
Last Posted Date
2025-03-04
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
35
Registration Number
NCT03728335
Locations
πŸ‡ΊπŸ‡Έ

City of Hope Medical Center, Duarte, California, United States

πŸ‡ΊπŸ‡Έ

Moffitt Cancer Center, Tampa, Florida, United States

A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

Phase 1
Completed
Conditions
Leukemia, Myeloid, Acute
Interventions
Drug: Arm 2 Probes
Drug: Arm 1 probes
Drug: Arm 3 probes
First Posted Date
2018-10-25
Last Posted Date
2024-02-28
Lead Sponsor
Celgene
Target Recruit Count
40
Registration Number
NCT03720366
Locations
πŸ‡°πŸ‡·

Local Institution - 201, Seoul, Korea, Republic of

πŸ‡¦πŸ‡Ί

Local Institution - 101, Melbourne, Australia

πŸ‡°πŸ‡·

Local Institution - 203, Seoul, Korea, Republic of

and more 7 locations

Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation

Phase 2
Recruiting
Conditions
Acute Bilineal Leukemia
Acute Biphenotypic Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
IDH2 Gene Mutation
Myelodysplastic Syndrome
Interventions
First Posted Date
2018-09-25
Last Posted Date
2025-02-26
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
50
Registration Number
NCT03683433
Locations
πŸ‡ΊπŸ‡Έ

M D Anderson Cancer Center, Houston, Texas, United States

IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation

Phase 1
Completed
Conditions
Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Interventions
First Posted Date
2018-05-03
Last Posted Date
2024-03-08
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
23
Registration Number
NCT03515512
Locations
πŸ‡ΊπŸ‡Έ

Johns Hopkins Cancer Center, Baltimore, Maryland, United States

πŸ‡ΊπŸ‡Έ

Dana Farber Cancer Institute, Boston, Massachusetts, United States

πŸ‡ΊπŸ‡Έ

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

and more 1 locations

Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Blasts 20-30 Percent of Bone Marrow Nucleated Cells
Chronic Myelomonocytic Leukemia
IDH2 Gene Mutation
Myelodysplastic Syndrome With Excess Blasts
Recurrent High Risk Myelodysplastic Syndrome
Refractory High Risk Myelodysplastic Syndrome
Interventions
Other: Quality-of-Life Assessment
First Posted Date
2017-12-26
Last Posted Date
2025-02-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
63
Registration Number
NCT03383575
Locations
πŸ‡ΊπŸ‡Έ

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

πŸ‡ΊπŸ‡Έ

Cleveland Clinic Foundation, Cleveland, Ohio, United States

πŸ‡ΊπŸ‡Έ

M D Anderson Cancer Center, Houston, Texas, United States

Β© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy