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 to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
- First Posted Date
- 2017-09-21
- Last Posted Date
- 2020-07-17
- Lead Sponsor
- Celgene
- Target Recruit Count
- 31
- Registration Number
- NCT03290443
- Locations
- 🇺🇸
New Orleans Center of Clinical Research, Knoxville, Tennessee, United States
🇺🇸DaVita Clinical Research, Minneapolis, Minnesota, United States
🇺🇸Clinical Pharmacology of Miami, LLC, Miami, Florida, United States
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
- Conditions
- Pediatric Cancer
- Interventions
- First Posted Date
- 2016-06-24
- Last Posted Date
- 2025-01-10
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Target Recruit Count
- 455
- Registration Number
- NCT02813135
- Locations
- 🇫🇷
CHU Angers, Angers, France
🇫🇷Centre Léon Bérard, Lyon, France
🇫🇷CHU Pellegrin, Bordeaux, France
Study of Orally Administered Enasidenib (AG-221) in Adults With Advanced Solid Tumors, Including Glioma, or Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation
- Conditions
- ChondrosarcomaSolid TumorGliomaIntrahepatic CholangiocarcinomaAngioimmunoblastic T-cell Lymphoma
- Interventions
- First Posted Date
- 2014-10-24
- Last Posted Date
- 2021-02-23
- Lead Sponsor
- Celgene
- Target Recruit Count
- 21
- Registration Number
- NCT02273739
Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation
- First Posted Date
- 2013-08-05
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- Celgene
- Target Recruit Count
- 345
- Registration Number
- NCT01915498
- Locations
- 🇺🇸
University of Miami Sylvester Cancer Center, Miami, Florida, United States
🇺🇸Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
Drug Development Updates
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