Rilzabrutinib
As of the edition of 20 October 2026, Rilzabrutinib is a small molecule: marketed, first approved in 2025 (US); acts on BTK; US protection ends in 2041.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Wayrilz
- First approved
- 29 August 2025 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 20, 1 stopped early
- Disease areas
- Immune system; Blood and lymph; Skin and connective tissue; Inherited and neonatal; Digestive system; Eye
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Sanofi.
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 product8 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| BTK | Tyrosine-protein kinase BTK | Q06187 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 4 | 0 | 0 |
| Phase 2 | 9 | 6 | 3 | 0 |
| Phase 3 | 7 | 0 | 6 | 1 |
| All trials | 20 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator, Applicant and Lead sponsor of trials | 2016 to now |