Remibrutinib
Small moleculeapproved
Approved
Sep 30, 2025
Clinical trial activity
28 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
24
Phase 3
16
Phase 4
0
Earliest trial started Aug 18, 2016 (NCT03918980)
Timeline
Indications
Approved for
Studied for
- Asthma · Phase 2
- Brain Diseases · Phase 2
- Dermatitis, Atopic · Phase 1
- Hidradenitis Suppurativa · Phase 3
- Liver Diseases · Phase 1
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Multiple Sclerosis · Phase 3
- Myasthenia Gravis · Phase 3
- Peanut Hypersensitivity · Phase 2
- Sjogren's Syndrome · Phase 2
- Urticaria · Phase 2
Mechanism of action
- Tyrosine-protein kinase BTKINHIBITOR
BTK inhibitor
Approval history
- approvedPriority reviewSep 30, 2025
Chemistry & pharmacology
Loading structure…
SMILES
C=CC(=O)N(C)CCOc1c(N)ncnc1-c1cc(F)cc(NC(=O)c2ccc(C3CC3)cc2F)c1C- Mol. weight
- 507.54 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4483575 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07222956 | Phase 2 | Apr 1, 2026 | Novartis, The Cleveland Clinic |
| NCT07225504 | Phase 3 | Dec 1, 2025 | Novartis |
| NCT07032272 | Phase 1 | Jul 23, 2025 | Novartis |
| NCT06868212 | Phase 3 | Jul 11, 2025 | Novartis |
| NCT06846281 | Phase 3 | Jun 16, 2025 | Novartis |
| NCT06865651 | Phase 2 | Mar 21, 2025 | Novartis |
| NCT06840392 | Phase 3 | Mar 12, 2025 | Novartis |
| NCT06799000 | Phase 3 | Jan 31, 2025 | Novartis |
| NCT06744920 | Phase 3 | Dec 23, 2024 | Novartis |
| NCT05976243 | Phase 3 | Dec 7, 2023 | Novartis |
| NCT06042478 | Phase 3 | Nov 15, 2023 | Novartis |
| NCT05677451 | Phase 3 | Jul 11, 2023 | Novartis |
| NCT05818553 | Phase 2 | Apr 11, 2023 | Praxis Biologics |
| NCT05795153 | Phase 3 | Apr 5, 2023 | Novartis |
| NCT05513001 | Phase 3 | Dec 9, 2022 | Novartis |
| NCT05753592 | Phase 1 | Oct 31, 2022 | Novartis |
| NCT05432388 | Phase 2 | Oct 12, 2022 | Novartis |
| NCT05048342 | Phase 3 | Jan 14, 2022 | Novartis |
| NCT05147220 | Phase 3 | Dec 15, 2021 | Novartis |
| NCT05156281 | Phase 3 | Dec 13, 2021 | Novartis |
Showing 20 of 28 trials
Page 1 / 2
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 27 | 26 | 4 | 2016 |
| Praxis Biologics | For profit | 1 | 1 | 1 | 2023 |
| The Cleveland Clinic | Academic/Hospital | 1 | 1 | 1 | 2026 |
3 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Novartis | For profit | MKTG | Sep 30, 2025 |