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Enasidenib

Alternative Names: enasidenib, ag-221, ag221, idhifa
Latest Update: 2025-01-16
Latest Update Note: Clinical Trial Update

Product Description

Enasidenib, a selective inhibitor of mutant IDH2 enzymes, was safe and well tolerated in patients with IDH2-mutated myeloid malignancies. (Sourced from: https://ashpublications.org/blood/article/130/6/722/36814/Enasidenib-in-mutant-IDH2-relapsed-or-refractory)

Mechanisms of Action: IDH2 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Approved

Approved Countries: Canada | Greece | United States

Approved Indications: Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia

Known Adverse Events: Diarrhea

Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Enasidenib

Countries in Clinic: Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Italy, Korea, Russia, Spain, Turkey, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 14

Highest Development Phases

Phase 3: Acute Myeloid Leukemia

Phase 2: Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Allogeneic Stem Cell Transplant|Anemia|Anemia, Refractory, with Excess of Blasts|Blast Crisis|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Leukopenia|Myelodysplastic Syndrome|Myelofibrosis|Myeloproliferative Disorders|Preleukemia|T-Cell Peripheral Lymphoma|Thrombocytopenia

Phase 1: Healthy Volunteers

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
NCT06756308

P2

Recruiting

T-Cell Peripheral Lymphoma

2027-12-01

NCT06240754

P2

Recruiting

Thrombocytopenia|Leukopenia|Anemia

2026-09-30

2018-001693-25

P2

Active, not recruiting

Myelodysplastic Syndrome

2026-02-14

2019-001416-30

P2

Active, not recruiting

Acute Myelomonocytic Leukemia|Myelodysplastic Syndrome|Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Acute Monocytic Leukemia|Allogeneic Stem Cell Transplant

2025-06-18

Recent News Events

Date

Type

Title

01/14/2025

News Article

 Taiho Oncology Announces Decitabine and Cedazuridine to be Included in NIH Precision Medicine Trials

08/15/2024

News Article

 Bicara Therapeutics Expands Board of Directors with Appointments of Mike Powell, Ph.D., and Christopher Bowden, M.D.

05/23/2024

News Article

 Bristol Myers Squibb to Present Data at ASCO & EHA from More Than 130 Studies Across 25 Diseases Supporting Expansion into New Indications, Demonstrating Long-Term Survival, and Highlighting Novel Modalities and Research Platforms

06/05/2023

News Article

 ENSEM Announces the Promotion of Shengfang Jin, PhD to President & Chief Executive Officer

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