Tolebrutinib
As of the edition of 20 October 2026, Tolebrutinib is a small molecule: marketed, first approved in 2026 (EU); acts on BTK.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Cenrifki
- First approved
- 19 June 2026 (EU)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Sanofi
- Registered trials
- 14, 1 stopped early
- Disease areas
- Immune system; Nervous system; Cancer; Digestive system; Pregnancy and women's health; Urinary and reproductive
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 | 5 | 5 | 0 | 0 |
| Phase 2 | 3 | 2 | 0 | 0 |
| Phase 3 | 6 | 4 | 1 | 1 |
| All trials | 14 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator and Lead sponsor of trials | 2019 to now |