Product Description
Ceritinib is an orally available inhibitor of the receptor tyrosine kinase activity of anaplastic lymphoma kinase (ALK) with antineoplastic activity. Upon administration, ceritinib binds to and inhibits wild-type ALK kinase, ALK fusion proteins and ALK point mutation variants. Inhibition of ALK leads to both the disruption of ALK-mediated signaling and the inhibition of cell growth in ALK-overexpressing tumor cells. Ceritinib is a small molecule tyrosine kinase receptor inhibitor and antineoplastic agent that is used in the therapy of selected forms of advanced non-small cell lung cancer (NSCLC). (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Ceritinib)
Mechanisms of Action: ALK Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Canada | Chile | Croatia | Czech | Denmark | Dominican Republic | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Novartis
Company Location: Europe
Company CEO: Vasant Narasimhan
Additional Commercial Interests: BeiGene
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Non-Small-Cell Lung Cancer
Phase 2: Melanoma|Squamous Cell Carcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02645149 |
Match Mel | P2 |
Completed |
Melanoma |
2025-11-01 |
12% |
2025-12-11 |
|
NCT03737994 |
The NCI-NRG ALK Protocol | P2 |
Active, not recruiting |
Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer |
2021-07-21 |
2024-01-04 |
Primary Endpoints|Treatments |
|
NCT03501368 |
MCC-19475 | P1 |
Active, not recruiting |
Melanoma |
2022-10-28 |
50% |
2024-05-01 |
Primary Endpoints|Study Completion Date|Treatments |
2013-000319-26 |
2013-000319-26 | P3 |
Completed |
Non-Small-Cell Lung Cancer |
2024-01-07 |
27% |
2025-07-08 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/01/2025 |
News Article |
Whitehawk Therapeutics Appoints Margaret Dugan, MD, as Chief Medical Officer |
|
04/09/2025 |
News Article |
Barbara Weber, M.D., Elected to ITM Supervisory Board |
|
09/09/2024 |
News Article |
Updated Data for Nuvalent's ALK-Selective Inhibitor, NVL-655, and ROS1-Selective Inhibitor, Zidesamtinib, Continue to Support Potential Best-in-Class Profiles |
|
06/06/2024 |
News Article |
Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor |