tirabrutinib(ONO-4059) hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple clinical trials spanning Phase 1 to Phase 3 evaluate the safety and efficacy of tirabrutinib hydrochloride for oncological and autoimmune indications, with sponsorship from organizations including Ono Pharmaceutical Co., Ltd., Gilead Sciences, and Kyorin University. These studies target B-cell malignancies—such as primary central nervous system lymphoma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma—alongside autoimmune conditions including Sjogren's syndrome, rheumatoid arthritis, and chronic spontaneous urticaria. Trial recruitment statuses across these protocols encompass active, recruiting, completed, terminated, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06940791	RECRUITING	Primary Central Nervous System Lymphoma	Kyorin University	2023-10-06	PHASE2
NCT06541665	ACTIVE_NOT_RECRUITING	Primary Central Nervous System Lymphoma	Ono Pharmaceutical Co., Ltd.	2024-05-17	PHASE1
NCT07104032	RECRUITING	Relapsed/Refractory Primary Central Nervous System Lymphoma	Ono Pharmaceutical Co., Ltd.	2026-06-12	PHASE3
NCT06696716	ACTIVE_NOT_RECRUITING	Pemphigus; Steroid-resistant Pemphigus	Ono Pharmaceutical Co., Ltd.	2022-08-15	PHASE3
NCT07198087	COMPLETED	Primary Central Nervous System Lymphoma (PCNSL)	Ono Pharmaceutical Co., Ltd.	2025-10-01	PHASE1
NCT04947319	ACTIVE_NOT_RECRUITING	Refractory Primary Central Nervous System Lymphoma; Primary CNS Lymphoma	Ono Pharmaceutical Co., Ltd.	2021-12-29	PHASE2
NCT02457598	TERMINATED	B-cell Malignancies	Gilead Sciences	2015-06-16	PHASE1
NCT04827589	WITHDRAWN	Chronic Spontaneous Urticaria	Gilead Sciences	2021-07	PHASE2
NCT02457559	COMPLETED	Relapsed/Refractory B-cell Malignancies	Gilead Sciences	2015-09-10	PHASE1
NCT02968563	COMPLETED	Chronic Lymphocytic Leukemia	Gilead Sciences	2016-12-13	PHASE2
NCT02983617	COMPLETED	Chronic Lymphocytic Leukemia	Gilead Sciences	2017-04-06	PHASE2
NCT03100942	COMPLETED	Sjogren's Syndrome	Gilead Sciences	2017-05-01	PHASE2
NCT02626026	COMPLETED	Rheumatoid Arthritis	Gilead Sciences	2016-01-26	PHASE1
NCT01659255	COMPLETED	Non Hodgkins Lymphoma; Chronic Lymphocytic Leukaemia	Gilead Sciences	2012-08-17	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the tirabrutinib(ONO-4059) hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tirabrutinib hydrochloride selectively binds to and inhibits Bruton's tyrosine kinase (BTK) with an IC50 of 2.2 nM, blocking downstream B-cell receptor signal transduction and pro-survival biochemical cascades. This signaling blockade suppresses B-lymphocyte proliferation and induces apoptosis, thereby inhibiting tumor progression in clinical conditions such as primary central nervous system lymphoma and chronic lymphocytic leukemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).