Ceritinib clinical trials
Ceritinib is named as an intervention in 7 current clinical trials in our Canada, USA, Spain, Italy, Belgium, Singapore, Australia, China, Germany, France, Poland, Czechia, Brazil, Japan, South Korea, Taiwan and Norway registers. 4 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Novartis Pharmaceuticals (2). The most-studied condition is ALK-positive NSCLC.
Where Ceritinib is approved
All regulators →Of the three regulators tracked here, the first to approve Ceritinib was the US, on 29 Apr 2014. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Ceritinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ceritinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 13 Dec 2037 (US 12357630).
- Latest patent on the drug substance itself: 18 Jan 2032 (US 9309229).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ceritinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ceritinib works
All drug targets →- ALK tyrosine kinase receptor inhibitor InhibitorTarget: ALK ALK receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- EML4-ALK inhibitor InhibitorTarget: EML4-ALK✓ In ChEMBL and the Guide to Pharmacology
- NPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor) inhibitor InhibitorTarget: NPM/ALK (Nucleophosmin/ALK tyrosine kinase receptor)✓ In ChEMBL and the Guide to Pharmacology
- Soft tissue sarcomaPhase 3
- CancerPhase 2
- CholangiocarcinomaPhase 2
- Colorectal adenocarcinomaPhase 2
- Esophageal adenocarcinomaPhase 2
- Gastric adenocarcinomaPhase 2
- Hematopoietic and lymphoid cell neoplasmPhase 2
- Hepatocellular carcinomaPhase 2
- Lung adenocarcinomaPhase 2
- Malignant pancreatic neoplasmPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2403108, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7397, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Ceritinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Ceritinib. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ceritinib for untreated ALK-positive non-small-cell lung cancer NICE TA500 | Recommended | 24 Jan 2018 | Current |
| Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer NICE TA395 | Recommended | 22 Jun 2016 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Ceritinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ZykadiaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ceritinib
- ATC code
- L01XE28
- ChEMBL
- CHEMBL2403108
- DrugBank
- DB09063
- PubChem CID
- 57379345
- CAS number
- 1032900-25-6
- FDA UNII
- K418KG2GET
- Wikidata
- Q21011233
- Wikipedia
- Ceritinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ceritinib
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ceritinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Ceritinib on the HPRA medicines list.
- Zykadia 150 mg film-coated tabletNovartis Europharm Limited · EU/1/15/999/004
- Zykadia 150 mg hard capsulesNovartis Europharm Limited · EU/1/15/999/001-003
Supply shortages
No entry for Ceritinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ceritinib
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 2 |
| Shandong University | 1 |
| Oslo University Hospital | 1 |
| Giselle Sholler | 1 |
| Kevin Petrecca | 1 |
| University Health Network, Toronto | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Ceritinib trials
How many clinical trials are testing Ceritinib?
7 current trials in our Canada, USA, Spain, Italy, Belgium, Singapore, Australia, China, Germany, France, Poland, Czechia, Brazil, Japan, South Korea, Taiwan and Norway registers name Ceritinib (also registered as LDK378) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ceritinib trials recruiting patients?
Yes. 4 of the 7 trials are recruiting: 2 with sites in Canada, 1 with sites in China and 1 with sites in Norway. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ceritinib clinical trials?
Novartis Pharmaceuticals (2), Shandong University (1), Oslo University Hospital (1) and Giselle Sholler (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Ceritinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Ceritinib, for example Zykadia 150 mg film-coated tablet (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ceritinib shortage?
Not in the lists we track: Ceritinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ceritinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ceritinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ceritinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.