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: None *
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: Lymphoma | Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Oncology Unspecified | Lymphoma | Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Lung Cancer | Oncology Unspecified
Known Adverse Events: Abdominal Pain | Pain Unspecified | Constipation | Diarrhea | Weight Loss
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: BeiGene
Clinical Description
Countries in Clinic: Australia, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Sarcoma
Phase 2: Melanoma|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
MatchMel | P2 |
Recruiting |
Melanoma |
2027-07-01 |
|
MULTISARC | P3 |
Active, not recruiting |
Sarcoma |
2023-12-31 |
|
MCC-19475 | P1 |
Active, not recruiting |
Melanoma |
2022-10-28 |
|
The NCI-NRG ALK Protocol | P2 |
Active, not recruiting |
Squamous Cell Carcinoma|Non-Small-Cell Lung Cancer |
2021-07-21 |