Nilotinib
As of the edition of 20 October 2026, Nilotinib is a small molecule: marketed, first approved in 2007 (CH); acts on ABL1; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Tasigna
- First approved
- 24 July 2007 (CH)
- Approvals on record
- 14 in 5 regions
- Holder of the most recent approval
- Cycle Pharmaceuticals; 5 holders in all
- Registered trials
- 159, 24 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Digestive system; Skin and connective tissue; Lungs and airways
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 product21 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 21 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ABL1 | Tyrosine-protein kinase ABL1 | P00519 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 18 | 7 | 1 | 0 |
| Phase 1 | 29 | 23 | 1 | 4 |
| Phase 2 | 72 | 42 | 13 | 13 |
| Phase 3 | 23 | 17 | 0 | 4 |
| Phase 4 | 17 | 11 | 1 | 3 |
| All trials | 159 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 2007 to now |
| Azurity Pharmaceuticals | Later holder | 2024 to now |
| Flex Pharma | Later holder | 2026 to now |
| Cycle Pharmaceuticals | Acquired holder | 2026 to now |