Rilzabrutinib
Small moleculeapprovedOrphan Drug FDA
Approved
Aug 29, 2025
Clinical trial activity
20 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
16
Phase 3
7
Phase 4
0
Earliest trial started Feb 1, 2016 (NCT02704429)
Timeline
Indications
Approved for
Studied for
- Anemia, Hemolytic, Autoimmune · Phase 3
- Anemia, Sickle Cell · Phase 3
- Asthma · Phase 2
- Autoimmune Diseases · Phase 1
- Chronic Urticaria · Phase 2
- Dermatitis, Atopic · Phase 2
- Glomerulonephritis · Phase 2
- Glomerulosclerosis, Focal Segmental · Phase 2
- Graves Disease · Phase 2
- Healthy Volunteers · Phase 1
- Immunoglobulin G4-Related Disease · Phase 3
- Liver Diseases · Phase 1
- Pemphigus · Phase 3
Mechanism of action
- Tyrosine-protein kinase BTKINHIBITOR
BTK inhibitor
Approval history
- approvedAug 29, 2025
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)(/C=C(\C#N)C(=O)N1CCC[C@@H](n2nc(-c3ccc(Oc4ccccc4)cc3F)c3c(N)ncnc32)C1)N1CCN(C2COC2)CC1- Mol. weight
- 665.77 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3702854 ↗
Also known as
- prn1008
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07007962 | Phase 3 | Oct 24, 2025 | Sanofi |
| NCT07216079 | Phase 3 | Oct 15, 2025 | Sanofi |
| NCT07190196 | Phase 3 | Sep 26, 2025 | Sanofi |
| NCT06984627 | Phase 2 | Sep 2, 2025 | Sanofi |
| NCT07086976 | Phase 3 | Aug 18, 2025 | Sanofi |
| NCT06975865 | Phase 3 | Aug 12, 2025 | Sanofi |
| NCT06500702 | Phase 2 | Aug 22, 2024 | Sanofi |
| NCT06342700 | Phase 1 | Mar 25, 2024 | Sanofi |
| NCT05104892 | Phase 2 | Nov 30, 2021 | Sanofi |
| NCT05002777 | Phase 2 | Nov 30, 2021 | Sanofi |
| NCT05107115 | Phase 2 | Nov 19, 2021 | Sanofi |
| NCT05018806 | Phase 2 | Sep 9, 2021 | Sanofi |
| NCT04748926 | Phase 1 | Apr 7, 2021 | Sanofi, Sanofi-Aventis |
| NCT06444191 | Phase 1 | Jan 4, 2021 | Sanofi, Sanofi-Aventis |
| NCT04562766 | Phase 3 | Dec 14, 2020 | Principia Biopharma, Inc. |
| NCT06444204 | Phase 1 | Nov 2, 2020 | Sanofi, Sanofi-Aventis |
| NCT04520451 | Phase 2 | Aug 21, 2020 | Harvard University, Sanofi-Aventis |
| NCT03762265 | Phase 3 | Jan 8, 2019 | Principia Biopharma, Inc. |
| NCT03395210 | Phase 1/Phase 2 (Phase 2) | Dec 5, 2017 | Principia Biopharma, Inc. |
| NCT02704429 | Phase 2 | Feb 1, 2016 | Principia Biopharma, Inc. |
Showing 20 of 20 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 15 | 12 | 3 | 2020 |
| Principia Biopharma, Inc. | For profit | 4 | 4 | 2 | 2016 |
| Sanofi-Aventis | For profit | 4 | 4 | 2 | 2020 |
| Harvard University | Academic/Hospital | 1 | 0 | 1 | 2020 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Genzyme | For profit | MKTG | Aug 29, 2025 |