enasidenib
enasidenib: sourced relationships with 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 · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| BRISTOL MYERS SQUIBB CO (BMY) Reported 2017-08-01 · Current development: unknownSource | Approved |
| BRISTOL MYERS SQUIBB CO (BMY) Reported 2017-08-01 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (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
Which companies have sourced relationships with enasidenib?
enasidenib has dated SEC/FDA relationship records for 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.