NDAORALTABLETPriority Review
Approved
Aug 2017
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IDHIFA (enasidenib mesylate) is an oral small-molecule tablet approved by the FDA on August 1, 2017, for the treatment of Acute Myeloid Leukemia (AML). As an IDH2 inhibitor, it works by targeting isocitrate dehydrogenase 2 mutations found in certain AML patients, differentiating mutant cells and promoting differentiation. It represents an important targeted therapy option in the AML treatment landscape, particularly for patients with IDH2-mutant disease.
$0.1BPart D
8.4 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
$119M Medicare spend — this is a commercially significant brand
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.