Drugs / Tirabrutinib
Tirabrutinib
also known as
ONO-4059 · GS-4059 · GS-4059 hydrochloride · GS/ONO-4059 · ONO-4059 hydrochloride · ONO-4059(FREE BASE) · TIRABRUTINIB HYDROCHLORIDE · Velexbru
Small molecule targets BTK via inhibition
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT07198087 | Oct 2025 → Apr 2026 | primary central nervous system lymphoma | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06541665 | May 2024 → Apr 2028 expected | primary central nervous system lymphoma | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02626026 | Jan → Sep 2016 | rheumatoid arthritis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02457559 | Sep 2015 → Dec 2020 | B-cell neoplasm | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02457598 | Jun 2015 → Sep 2024 | B-cell neoplasm | Gilead Sciences | Terminated | No outcome recorded |
| Phase 1 | NCT01659255 | Aug 2012 → Feb 2015 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Gilead Sciences | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06940791 | Oct 2023 → Feb 2030 expected | primary central nervous system lymphoma | Kyorin University | Recruiting | No outcome recorded |
| Phase 2 | NCT04947319 | Dec 2021 → Jan 2026 overdue | primary central nervous system lymphoma | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04827589 | Jul 2021 → Apr 2022 | chronic idiopathic urticaria | Gilead Sciences | Withdrawn | No outcome recorded |
| Phase 2 | NCT03100942 | May 2017 → Jan 2019 | Sjogren syndrome | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02983617 | Apr 2017 → Feb 2019 | B-cell chronic lymphocytic leukemia | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02968563 | Dec 2016 → Jun 2019 | B-cell chronic lymphocytic leukemia | Gilead Sciences | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07104032 | Jun 2026 → Dec 2027 expected | primary central nervous system lymphoma | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT06696716 Comparator | Aug 2022 → Sep 2027 expected | pemphigus | Ono Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2014-12-19 | Gilead Sciences | ONO and Gilead Announce Exclusive License Agreement to Develop BTK Inhibitor, ONO-4059, for the Treatment of B-cell Malignancies and Other Diseases gilead.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tirabrutinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02983617 ↗ |
| Known as | GS-4059 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Known as | GS-4059 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Known as | GS/ONO-4059 | “selective Bruton's tyrosine kinase inhibitor tirabrutinib (GS/ONO-4059).” PMID 31827243 ↗ Dec 2019 |
| Known as | ONO-4059 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06541665 ↗ |
| Known as | ONO-4059 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Known as | ONO-4059(FREE BASE) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Known as | TIRABRUTINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Known as | Velexbru | ChEMBL registry synonym — accepted as the source's own label CHEMBL4071161 ↗ |
| Action | Inhibit | “tirabrutinib 40 mg (Bruton's tyrosine kinase inhibitor)” PMID 35377447 ↗ Nov 2022 |
| Modality | Small molecule | — CHEMBL4071161 ↗ |
| Route | Oral | “Capsules administered orally” NCT01659255 ↗ |
| Target | BTK | “it acts by blocking Bruton tyrosine kinase, an important protein in the development of PCNSL.” PMID 42317052 ↗ Jun 2026 |