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Tirabrutinib

Generic Name
Tirabrutinib
Drug Type
Small Molecule
Chemical Formula
C25H22N6O3
CAS Number
1351636-18-4
Unique Ingredient Identifier
LXG44NDL2T
Background

Tirabrutinib is under investigation in clinical trial NCT02626026 (Safety and Pharmacokinetics of GS-4059 in Healthy Volunteers and Subjects With Rheumatoid Arthritis (RA)).

Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)

Phase 2
Recruiting
Conditions
Primary Central Nervous System Lymphoma
Interventions
Drug: Placebo
First Posted Date
2025-04-23
Last Posted Date
2025-04-23
Lead Sponsor
Kyorin University
Target Recruit Count
92
Registration Number
NCT06940791
Locations
🇯🇵

Kyorin University Hospital, Tokyo, Japan

ONO-4059 Study in Patients With Steroid-resistant Pemphigus

Phase 3
Recruiting
Conditions
Pemphigus
Steroid-resistant Pemphigus
Interventions
Drug: ONO-4059 placebo
First Posted Date
2024-11-20
Last Posted Date
2025-02-14
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
34
Registration Number
NCT06696716
Locations
🇯🇵

Ichinomiya Municipal Hospital, Aichi, Japan

🇯🇵

Nagoya City University Hospital, Aichi, Japan

🇯🇵

Kurume University Hospital, Fukuoka, Japan

and more 17 locations

Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL

Phase 1
Recruiting
Conditions
Primary Central Nervous System Lymphoma
Interventions
First Posted Date
2024-08-07
Last Posted Date
2024-12-09
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
20
Registration Number
NCT06541665
Locations
🇯🇵

Kindai University Hospital, Osakasayama-shi, Osaka, Japan

🇯🇵

Institute of Science Tokyo Hospital, Bunkyo-ku, Tokyo, Japan

🇯🇵

National Hospital Organization Disaster Medical Center, Midori-cho, Tokyo, Japan

and more 41 locations

Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

Phase 2
Recruiting
Conditions
Primary CNS Lymphoma
Refractory Primary Central Nervous System Lymphoma
Interventions
First Posted Date
2021-07-01
Last Posted Date
2025-04-06
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
112
Registration Number
NCT04947319
Locations
🇺🇸

University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States

🇺🇸

Mayo Clinic- Phoenix, Phoenix, Arizona, United States

🇺🇸

City of Hope Comprehensive Breast Cancer Center, Duarte, California, United States

and more 42 locations

Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria

Phase 2
Withdrawn
Conditions
Chronic Spontaneous Urticaria
Interventions
Drug: Placebo
First Posted Date
2021-04-01
Last Posted Date
2021-07-28
Lead Sponsor
Gilead Sciences
Registration Number
NCT04827589

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

First Posted Date
2017-04-04
Last Posted Date
2020-10-23
Lead Sponsor
Gilead Sciences
Target Recruit Count
152
Registration Number
NCT03100942
Locations
🇺🇸

Clinical Research of West Florida, Inc., Clearwater, Florida, United States

🇺🇸

Center for Rheumatology Immunology and Arthritis, Fort Lauderdale, Florida, United States

🇺🇸

IRIS Research and Development, LLC, Plantation, Florida, United States

and more 49 locations

Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)

Phase 2
Completed
Conditions
Chronic Lymphocytic Leukemia
Interventions
First Posted Date
2016-12-06
Last Posted Date
2021-12-21
Lead Sponsor
Gilead Sciences
Target Recruit Count
36
Registration Number
NCT02983617
Locations
🇩🇪

Evangelisches Diakoniekrankenhaus Bremen Hämatologie, Bremen, Germany

🇩🇪

Universitätsklinikum Heidelberg, Abteilung Innere Medizin V, Heidelberg, Germany

🇩🇪

Uniklinik Köln Klinik I für Innere Medizin, Köln, Germany

and more 12 locations

Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Phase 2
Completed
Conditions
Chronic Lymphocytic Leukemia
Interventions
First Posted Date
2016-11-18
Last Posted Date
2022-01-21
Lead Sponsor
Gilead Sciences
Target Recruit Count
35
Registration Number
NCT02968563
Locations
🇩🇪

Ambulante Krebszentrum Schaubstraße, Frankfurt, Brandenburg, Germany

🇩🇪

KH Maria Hilf-Franziskushaus, Mönchengladbach, Mönchengladbach, Germany

🇩🇪

Klinikum Rechts der Isar der Technischen Universität München, München, Germany

and more 11 locations

Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)

Phase 1
Completed
Conditions
Rheumatoid Arthritis
Interventions
Drug: Placebo
First Posted Date
2015-12-10
Last Posted Date
2020-09-09
Lead Sponsor
Gilead Sciences
Target Recruit Count
42
Registration Number
NCT02626026
Locations
🇺🇸

Lovelace Scientific Resources, Inc., Venice, Florida, United States

🇺🇸

Center for Arthritis & Osteoporosis, Elizabethtown, Kentucky, United States

🇺🇸

Altoona Center for Clinical Research, Duncansville, Pennsylvania, United States

and more 6 locations

Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies

Phase 1
Completed
Conditions
Relapsed/Refractory B-cell Malignancies
Interventions
First Posted Date
2015-05-29
Last Posted Date
2022-03-24
Lead Sponsor
Gilead Sciences
Target Recruit Count
29
Registration Number
NCT02457559
Locations
🇫🇷

Hopital Saint Eloi, Montpellier, France

🇫🇷

Centre Hospitalier Lyon Sud, Pierre Benite, France

🇬🇧

Leicester Royal Infirmary, Leicester, United Kingdom

and more 3 locations
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