Zanubrutinib
As of the edition of 20 October 2026, Zanubrutinib is a small molecule: marketed, first approved in 2019 (US); acts on BTK; 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
- Brukinsa
- First approved
- 14 November 2019 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- BeiGene; 3 holders in all
- Registered trials
- 183, 2 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Heart and blood vessels; Digestive system; Infections
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 BeiGene.
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 product32 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 32 listings behind itRequest access. Nothing is shown until you do.
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 Zanubrutinib.
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 |
|---|---|---|
| BTK | Tyrosine-protein kinase BTK | Q06187 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 0 | 7 | 0 |
| Phase 1 | 26 | 15 | 10 | 1 |
| Phase 2 | 128 | 17 | 83 | 1 |
| Phase 3 | 14 | 2 | 12 | 0 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 183 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| BeiGene | Originator, Applicant, Acquired holder and Lead sponsor of trials | 2016 to now |