Tirabrutinib
As of the edition of 20 October 2026, Tirabrutinib is a small molecule: marketed, first approved in 2020 (JP); acts on BTK.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Velexbru
- First approved
- 25 March 2020 (JP)
- Approvals on record
- 3 in 1 region
- Holder of the most recent approval
- Ono Pharmaceutical
- Registered trials
- 13, 2 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Skin and connective tissue; Bones, joints and muscles; Eye
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| BTK | Tyrosine-protein kinase BTK | Q06187 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 4 | 1 | 1 |
| Phase 2 | 6 | 3 | 2 | 1 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 13 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ono Pharmaceutical | Applicant and Lead sponsor of trials | 2020 to now |