Product
Enasidenib
Aliases
2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate, 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1), AG-221, AG-221 Mesylate, CC-90007 (6 other aliases)
Name
Idhifa
INN Name
enasidenib mesylate
FDA Approved
Yes
22 clinical trials
1 organization
69 indications
1 document
Indication
Hematologic NeoplasmsIndication
Liver ImpairmentIndication
Acute Myeloid LeukemiaIndication
Chronic Myelomonocytic LeukemiaIndication
Relapsed CancerIndication
Refractory CancerIndication
IDH2 gene mutationIndication
ChondrosarcomaIndication
Sinonasal AdenocarcinomaIndication
Large-cell Neuroendocrine CarcinomaIndication
Olfactory NeuroblastomaIndication
SNUCIndication
Sinonasal Undifferentiated CarcinomaIndication
MyelofibrosisIndication
IDH2 MutationIndication
Recurrent Acute Myeloid LeukemiaIndication
LeukemiaIndication
myeloidIndication
AcuteIndication
Myelodysplastic SyndromesIndication
IDH2 R140Indication
Acute bilineal leukemiaIndication
Acute Biphenotypic LeukemiaIndication
Myelodysplastic SyndromeIndication
BCR-ABL1-positiveIndication
Breast Cancer, Stage IVIndication
AnaemiaIndication
Hodgkin lymphomaIndication
Non-Hodgkin LymphomaIndication
Hodgkin Lymphoma, Ann Arbor Stage IVIndication
Stage IV Non-Hodgkin LymphomaIndication
Atypical chronic myeloid leukemiaIndication
BCR-ABL1 NegativeIndication
Blast Phase Chronic Myelogenous LeukemiaIndication
Castration-Resistant Prostate CarcinomaIndication
Chronic Myelogenous LeukemiaIndication
Pancreatic CancerIndication
Breast CancerIndication
Metastatic Malignant Solid NeoplasmIndication
UnclassifiableIndication
Primary MyelofibrosisIndication
Acute Lymphoblastic LeukemiaIndication
Chronic Lymphocytic LeukemiaIndication
Recurrent Hematologic MalignancyIndication
Hodgkin LymphomaIndication
Myeloproliferative NeoplasmIndication
Multiple MyelomaIndication
Small Lymphocytic LymphomaIndication
Refractory Chronic Lymphocytic LeukemiaIndication
Refractory Hematologic MalignancyIndication
Hodgkin's LymphomaIndication
Malignant Solid NeoplasmIndication
Refractory Non-Hodgkin LymphomaIndication
Stage III Pancreatic CancerIndication
Prostate CancerIndication
Pancreatic AdenocarcinomaIndication
Pediatric CancerIndication
IDH MutationIndication
IDH1 MutationIndication
Blood CancerClinical trial
A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 MutationStatus: Completed, Estimated PCD: 2019-07-25
Clinical trial
A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (CC 90007) in Subjects With Mild, Moderate and Severe Hepatic ImpairmentStatus: Completed, Estimated PCD: 2023-03-08
Clinical trial
V-FAST: A Phase 1b Master Trial to Investigate CPX-351 Combined With Various Targeted Agents in Subjects With Previously Untreated Acute Myeloid LeukemiaStatus: Completed, Estimated PCD: 2022-02-07
Clinical trial
A Phase I Study of IDH2 Inhibition Using Enasidenib as Maintenance Therapy for IDH2-mutant Myeloid Neoplasms Following Allogeneic Stem Cell TransplantationStatus: Completed, Estimated PCD: 2021-12-31
Clinical trial
Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML)Status: Terminated, Estimated PCD: 2023-10-26
Clinical trial
Phase II Study of Enasidenib in IDH2-mutated Malignant Sinonasal and Skull Base TumorsStatus: Recruiting, Estimated PCD: 2027-12-31
Clinical trial
Pilot Trial of Enasidenib (AG-221) Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients With IDH2 MutationStatus: Active (not recruiting), Estimated PCD: 2024-12-15
Clinical trial
A Phase II Open-label Study of Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 MutationStatus: Completed, Estimated PCD: 2023-05-30
Clinical trial
Phase 1b Study of IDH Inhibition With Enasidenib and MEK Inhibition With Cobimetinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-Occurring IDH2 and RAS Signaling Gene MutationsStatus: Recruiting, Estimated PCD: 2025-05-02
Clinical trial
IDH2-Post-Allo-Trial: Enasidenib as Consolidation or Salvage Therapy for Patients With IDH2 Mutated AML or MDS Following Allogeneic Blood Stem Cell TransplantationStatus: Active (not recruiting), Estimated PCD: 2024-08-30
Clinical trial
Oral Decitabine-Based Maintenance Therapy in Patients With AML in RemissionStatus: Recruiting, Estimated PCD: 2026-12-31
Clinical trial
A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3/IDH1 or FLT3/IDH2 MutationsStatus: Recruiting, Estimated PCD: 2025-02-01
Clinical trial
An Open-Label Feasibility Study to Assess the Safety and Pharmacokinetics of Enasidenib in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML) With an Isocitrate Dehydrogenase-2 (IDH2) MutationStatus: Recruiting, Estimated PCD: 2030-12-31
Clinical trial
Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed/Refractory AMLStatus: Recruiting, Estimated PCD: 2025-09-20
Clinical trial
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: PRIMEStatus: Terminated, Estimated PCD: 2020-12-10
Clinical trial
Phase 1b/2 Study of Oral Decitabine/Cedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor EnasidenibStatus: Recruiting, Estimated PCD: 2024-11-29
Clinical trial
CPX-351 Plus Enasidenib for Relapsed Acute Myelogenous Leukemia Characterized by the IDH2 MutationStatus: Active (not recruiting), Estimated PCD: 2024-09-01
Clinical trial
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory TumorsStatus: Recruiting, Estimated PCD: 2027-08-01
Clinical trial
A Phase Ib Study of Fedratinib With IDH Inhibition in Advanced-Phase, IDH-Mutated Ph-Negative Myeloproliferative NeoplasmsStatus: Recruiting, Estimated PCD: 2025-10-01
Clinical trial
Randomized, Sequential, Open-Label Study to Evaluate the Efficacy of IDH Targeted/Non- Targeted Versus Non-targeted/IDH-targeted Approaches in the Treatment of Newly Diagnosed IDH Mutated AML Patients Not Candidates for Intensive Induction Therapy (I- DATA Study)Status: Recruiting, Estimated PCD: 2025-09-30
Clinical trial
Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic SyndromeStatus: Recruiting, Estimated PCD: 2025-02-28
Clinical trial
A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2: A Decentralized TrialStatus: Not yet recruiting, Estimated PCD: 2026-05-31
Document
DailyMed Label: IdhifaOrganization
Celgene Corporation