NDAORALTABLET
Approved
Mar 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
19
Data completeness
6/8 — Strong
ZYKADIA (ceritinib) by Novartis is tyrosine kinase inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2019.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYKADIA (ceritinib) is an oral tyrosine kinase inhibitor approved by the FDA in March 2019 for the treatment of ALK-positive non-small cell lung cancer. It works by blocking anaplastic lymphoma kinase (ALK), a protein that drives cancer cell growth in patients with specific genetic mutations.
$4MPart D
PeakStable
11.2 years to LOEZYKADIA is at peak commercial stage with modest Part D spending, suggesting stable but limited volume opportunity and a mature, potentially right-sized brand team.
Mechanism of Action
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 (19)
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
Started Jan 2019
103 enrolled
ALK-positive Advanced NSCLC
Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma
Started Jun 2018
27 enrolled
MelanomaUnresectable MelanomaAdvanced Melanoma
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Started Sep 2017
9 enrolled
Non-small Cell Lung Cancer
Ceritinib Rare Indications Study in ALK+ Tumors
Started May 2016
22 enrolled
Tumors With Aberrations in ALKAnaplastic Large Cell LymphomaInflammatory Myofibroblastic Tumor+1 more
Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis
Started Feb 2016
10 enrolled
GlioblastomaBrain Metastases
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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.