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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYKADIA (ceritinib) is an oral tyrosine kinase inhibitor approved in 2019 for treating ALK-positive non-small cell lung cancer and other kinase-driven malignancies. It works by blocking ALK and ROS1 tyrosine kinases, preventing cancer cell proliferation. The drug targets patients with specific genetic mutations who have progressed on or are intolerant to prior ALK inhibitor therapy.
$4MPart D
Peak11.5 years to LOEProduct is in peak commercial phase with modest Part D utilization, indicating a stable but niche market position within the kinase inhibitor oncology space.
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.