Orelabrutinib
As of the edition of 20 October 2026, Orelabrutinib is a small molecule: in active development; acts on BTK.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Active, 2026
- Kind
- Small molecule
- Registered trials
- 101, 0 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Nervous system; Skin and connective tissue; Bones, joints and muscles
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 not stated | 12 | 2 | 4 | 0 |
| Phase 1 | 5 | 3 | 0 | 0 |
| Phase 2 | 67 | 7 | 40 | 0 |
| Phase 3 | 15 | 1 | 9 | 0 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 101 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| InnoCare Pharma | Lead sponsor of trials | 2017 to now |
| InnoCare Pharma Tech | Lead sponsor of trials | 2018 to now |
| Zenas BioPharma | Lead sponsor of trials | 2026 to now |