Remibrutinib
As of the edition of 20 October 2026, Remibrutinib is a small molecule: marketed, first approved in 2025 (US); acts on BTK; US protection ends in 2034.
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
- Rhapsido
- First approved
- 30 September 2025 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 36, 2 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Infections; Nervous system; Bones, joints and muscles; Cancer
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. 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 product2 listings count towards this date. The exact date and each listing are in the product.
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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 Remibrutinib.
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 | 2 | 0 | 1 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 9 | 3 | 4 | 2 |
| Phase 3 | 22 | 4 | 18 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2022 to now |