Product Description
Tirabrutinib (Velexbru¨) is an orally administered, small molecule, Bruton's tyrosine kinase (BTK) inhibitor being developed by Ono Pharmaceutical and its licensee Gilead Sciences for the treatment of autoimmune disorders and haematological malignancies. Tirabrutinib irreversibly and covalently binds to BTK in B cells and inhibits aberrant B cell receptor signalling in B cell-related cancers and autoimmune diseases. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/32382949/)
Mechanisms of Action: Btk Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Lymphoma|Primary Central Nervous System Lymphoma *
Approval Status: Not Approved
Approved Countries: Japan | Taiwan
Approved Indications: None
Known Adverse Events: None
Company: ONO Pharm
Company Location: CHUO-KU OSAKA 541 JA M0
Company CEO:
Additonal Commercial Interests: Gilead Sciences
Clinical Description
Countries in Clinic: Japan, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Pemphigus
Phase 2: Chronic Lymphoid Leukemia|Primary Central Nervous System Lymphoma
Phase 1: Scleroderma, General
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2071230124 | P1 |
Not yet recruiting |
Primary Central Nervous System Lymphoma |
2028-03-31 |
|
| jRCT2031200315 | P1 |
Active, not recruiting |
Scleroderma, General |
2027-10-31 |
|
| PROSPECT Study | P2 |
Recruiting |
Primary Central Nervous System Lymphoma |
2027-03-31 |
|
| jRCT2031220043 | P3 |
Suspended |
Pemphigus |
2026-12-31 |