NDAORALCAPSULE
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TASIGNA (nilotinib) is an oral small-molecule tyrosine kinase inhibitor targeting Bcr-Abl, approved in 2007 for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is indicated for newly diagnosed chronic phase CML in pediatric patients (≥1 year) and for accelerated phase CML with resistance or intolerance to prior TKI therapy. TASIGNA represents a second-generation TKI option in the competitive CML treatment landscape, offering an alternative to first-line therapies.
$0.4BPart D
6.4 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.
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.