Enasidenib

Generic Name: Enasidenib

Brand Names: Idhifa

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₁₇F_₆N_₇O

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

A Study of Enasidenib in People With Clonal Cytopenia of Undetermined Significance

Phase 1

Active, not recruiting

Conditions: Clonal Cytopenia of Undetermined Significance
CCUS Clonal Cytopenia of Undetermined Significance

Interventions: Drug: Enasidenib

First Posted Date: 2021-11-01

Last Posted Date: 2025-05-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 4

Registration Number: NCT05102370

Locations: 🇺🇸
Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre, New York, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 9 locations

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Decitabine and Cedazuridine
Drug: Venetoclax
Drug: Gilteritinib
Drug: Enasidenib
Drug: Ivosidenib

First Posted Date: 2021-08-18

Last Posted Date: 2025-01-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 125

Registration Number: NCT05010772

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative Neoplasms

Phase 1

Withdrawn

Conditions: IDH Mutation
IDH1 Mutation
IDH2 Gene Mutation
Blood Cancer
Myeloproliferative Neoplasm

Interventions: Drug: Ivosidenib
Drug: Enasidenib
Drug: Fedratinib

First Posted Date: 2021-07-09

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Registration Number: NCT04955938

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

Decitabine/Cedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Decitabine and Cedazuridine
Drug: Ivosidenib
Drug: Enasidenib
Drug: Venetoclax

First Posted Date: 2021-03-01

Last Posted Date: 2025-04-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 84

Registration Number: NCT04774393

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

Phase 1

Withdrawn

Conditions: Recurrent Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib Fumarate
Drug: Enasidenib Mesylate
Drug: Glasdegib Maleate
Drug: Bosutinib Monohydrate
Drug: Decitabine
Drug: Ivosidenib
Drug: Venetoclax

First Posted Date: 2020-12-07

Last Posted Date: 2022-06-09

Lead Sponsor: City of Hope Medical Center

Registration Number: NCT04655391

Locations: 🇺🇸
City of Hope Meidcal Center, Duarte, California, United States

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Phase 1

Completed

Conditions: Hepatic Impairment

Interventions: Drug: Enasidenib

First Posted Date: 2020-10-05

Last Posted Date: 2024-07-15

Lead Sponsor: Celgene

Target Recruit Count: 40

Registration Number: NCT04573582

Locations: 🇺🇸
Local Institution - 002, Miami, Florida, United States
🇺🇸
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville, Knoxville, Tennessee, United States
🇺🇸
Local Institution - 003, Orlando, Florida, United States

IDH2-Post-Allo-Trial for Patients With IDH2-mut Myeloid Neoplasms After Allo-SCT

Phase 2

Active, not recruiting

Conditions: Leukemia, Myeloid, Acute
IDH2 R172
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
IDH2 Gene Mutation
IDH2 R140

Interventions: Drug: Enasidenib

First Posted Date: 2020-08-21

Last Posted Date: 2023-12-28

Lead Sponsor: Heinrich-Heine University, Duesseldorf

Target Recruit Count: 50

Registration Number: NCT04522895

Locations: 🇩🇪
Universitätsklinikum Heidelberg Innere Medizin V: Hämatologie, Onkologie und Rheumatologie, Heidelberg, Germany
🇩🇪
Universitätsklinikum Köln Klinik I für Innere Medizin, Köln, Germany
🇩🇪
Universitätsklinikum Leipzig Medizinische Klinik und Poliklinik I, Hämatologie und Zelltherapie, Leipzig, Germany

and more 8 locations

Bioavailability of Enasidenib (CC-90007) Sprinkle Formulation Relative to the Reference Tablet Formulation and Effect of Food on the Pharmacokinetics of Sprinkle Formulation in Healthy Adults

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Enasidenib

First Posted Date: 2020-03-17

Last Posted Date: 2020-03-17

Lead Sponsor: Celgene

Target Recruit Count: 28

Registration Number: NCT04310527

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

Phase 2

Completed

Conditions: Accelerated/Blast-phase Myeloproliferative Neoplasm
Chronic-phase Myelofibrosis
IDH2 Mutation

Interventions: Drug: Ruxolitinib
Drug: Enasidenib

First Posted Date: 2020-02-24

Last Posted Date: 2025-02-04

Lead Sponsor: John Mascarenhas

Target Recruit Count: 6

Registration Number: NCT04281498

Locations: 🇺🇸
Taussig Cancer Center Institute, Cleveland, Ohio, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 8 locations

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

Phase 2

Active, not recruiting

Conditions: Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Enasidenib
Drug: Enasidenib Mesylate

First Posted Date: 2019-12-18

Last Posted Date: 2025-04-29

Lead Sponsor: Children's Oncology Group

Target Recruit Count: 10

Registration Number: NCT04203316

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 25 locations

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