NDAORALCAPSULE
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TASIGNA (nilotinib) is an oral small-molecule tyrosine kinase inhibitor approved in 2007 for chronic myeloid leukemia (CML). It works by inhibiting BCR-ABL kinase activity, blocking the proliferation of leukemic cells. The drug is indicated for newly diagnosed and treatment-resistant CML in chronic phase.
$0.395BPart D
PeakStable
6.3 years to LOEThe product is at peak commercial maturity with 24,550 annual Part D claims and $395M spend, indicating a stable, well-established franchise with sustained team investment.
Mechanism 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.
Clinical Trials (20)
A Bioavailability Study of Nilotinib in Healthy, Adult, Human Subjects Under Fasted Conditions.
Started Nov 2024
128 enrolled
Cancer
Bioavailability Study of XS003 (Nilotinib)
Started Oct 2024
48 enrolled
Cancer
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Started Nov 2022
568 enrolled
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
Started Jun 2022
30 enrolled
Metastatic MelanomaBRAF Gene Mutation
Evaluating the Efficacy and Safety of Nilotinib BE in Subjects With Early Alzheimer's Disease
Started Feb 2022
1,275 enrolled
Alzheimer Disease
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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.