NDAORALTABLET
Approved
Nov 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
DANZITEN (nilotinib) by R-Pharm US is bcr-abl tyrosine kinase inhibitors [moa]. Approved for chronic myeloid leukemia, gastrointestinal stromal tumor. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DANZITEN (nilotinib) is an oral Bcr-Abl tyrosine kinase inhibitor approved November 2024 for chronic myeloid leukemia and gastrointestinal stromal tumor. It works by inhibiting the BCR-ABL kinase that drives CML proliferation, blocking abnormal cell growth in Philadelphia chromosome-positive patients.
Growth13.8 years to LOE
Early-stage growth product with significant market opportunity in oncology, likely supporting expanded brand and medical affairs teams at R-Pharm US.
Mechanism of Action
Bcr-Abl Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
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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.