NDAORALTABLET
Approved
Nov 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
DANZITEN (nilotinib) by R-Pharm US is bcr-abl tyrosine kinase inhibitors [moa]. First approved in 2024.
Drug data last refreshed 21h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DANZITEN (nilotinib) is an oral Bcr-Abl tyrosine kinase inhibitor approved by the FDA on November 7, 2024, for treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It works by selectively inhibiting the abnormal Bcr-Abl protein that drives these blood cancers.
Growth13.3 years to LOE
Early commercial phase with significant growth potential; lean team structure typical of recent launch requires broad skill sets across sales, marketing, and market access functions.
Mechanism of Action
Bcr-Abl Tyrosine Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
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.