enasidenib
enasidenib: developed by 1 company · 5 clinical trials tracked · 1 FDA decision.
enasidenib evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
How could enasidenib → BMY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (2)
| Company | Phase |
|---|---|
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
Clinical Trials (5)
A Phase 2 Study of Enasidenib in IDH2-Mutant Angioimmunoblastic T-Cell Lymphoma
Primary endpoint: response rate
A Pilot Study of Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2: A Decentralized Trial
Primary endpoint: Best hematologic response
Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials
Primary endpoint: Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment
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 Mutation
Primary endpoint: Number of MPN Participants With Response
Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome
Primary endpoint: Incidence of adverse events
FDA Decisions1 records
Frequently asked questions
Who is developing enasidenib?
enasidenib is being developed by BRISTOL MYERS SQUIBB CO.
How many clinical trials involve enasidenib?
BioSniper tracks 5 clinical trials involving enasidenib.
What is enasidenib's latest FDA decision?
The most recent tracked FDA decision for enasidenib is Approval for 1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test., dated August 1, 2017.