Ceritinib
As of the edition of 20 October 2026, Ceritinib is a small molecule: marketed, first approved in 2014 (US); acts on ALK; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Zykadia
- First approved
- 29 April 2014 (US)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 45, 12 stopped early
- Disease areas
- Cancer; Lungs and airways; Blood and lymph; Immune system; Digestive system; Hormones
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product10 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ceritinib.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ALK | ALK tyrosine kinase receptor | Q9UM73 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 1 | 0 |
| Phase 1 | 16 | 11 | 3 | 2 |
| Phase 2 | 19 | 7 | 1 | 10 |
| Phase 3 | 3 | 3 | 0 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 45 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2014 to now |