Ensartinib
As of the edition of 20 October 2026, Ensartinib is a small molecule: marketed, first approved in 2024 (US); acts on ALK; US protection ends in 2037.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Ensacove
- First approved
- 18 December 2024 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Xcovery
- Registered trials
- 37, 1 stopped early
- Disease areas
- Cancer; Lungs and airways; Nervous system; Blood and lymph; Immune system; Inherited and neonatal
US protection
US protection ends in 2037.
The last listed US drug-substance patent ends in 2037. The application that gives this date is held by Xcovery.
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 Ensartinib.
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 | 3 | 0 | 1 | 0 |
| Phase 1 | 6 | 3 | 1 | 0 |
| Phase 2 | 24 | 2 | 15 | 1 |
| Phase 3 | 3 | 0 | 2 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 37 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Xcovery | Originator and Lead sponsor of trials | 2024 to now |