Tirabrutinib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Central Nervous System LymphomaPrimary Central Nervous System Lymphoma

34 competitors in Central Nervous System Lymphoma

#DrugCompanyPhaseTrials

1

Rituxan

Roche

Approved

172

Idamycin

Pfizer

Approved

—3

Tepadina

Jazz Pharmaceuticals

Approved

—4

Brukinsa

BBeOne Medicines

Approved

15

Temodar

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

66

Trexall

Jazz Pharmaceuticals

Phase 2

197

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

48

Cytosar

Teva

Phase 2

69

Fludara

Sanofi

Phase 2

110

Gazyva

Roche

Phase 2

1Show 19 more competitors

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Chronic Lymphocytic Leukemia2 trials

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)

Completed·Gilead·Phase 2·NCT02968563·35 enrolled

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

Completed·Gilead·Phase 2·NCT02983617·36 enrolled

Primary Central Nervous System Lymphoma2 trials

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma

Recruiting·Ono Pharmaceutical Co. Ltd·Phase 3·NCT07104032·132 enrolled

Tirabrutinib Maintenance Versus Placebo in Patients With Primary Central Nervous System Lymphoma in Complete Remission: a Randomized Phase II Study (JCOG2104)

Recruiting·KKyorin University·Phase 2·NCT06940791·92 enrolled

Relapsed/Refractory1 trial

Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

Completed·Gilead·Phase 1·NCT01659255·90 enrolled

Relapsed/Refractory B-cell Malignancies1 trial

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

Completed·Gilead·Phase 1·NCT02457559·29 enrolled

Central Nervous System Lymphoma1 trial

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

Active, not recruiting·Ono Pharmaceutical Co. Ltd·Phase 2·NCT04947319·119 enrolled

5 more indications

B-cell Malignancies1 trial

Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

Terminated·Gilead·Phase 1·NCT02457598·203 enrolled

Chronic Spontaneous Urticaria1 trial

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

Withdrawn·Gilead·Phase 2·NCT04827589

Safety and Efficacy1 trial

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

Completed·Gilead·Phase 2·NCT03100942·152 enrolled

Rheumatoid Arthritis1 trial

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

Completed·Gilead·Phase 1·NCT02626026·42 enrolled

Primary Central Nervous System Lymphoma (PCNSL)1 trial

A Phase 1, Open-Label, Parallel-Group Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants

Completed·Ono Pharmaceutical Co. Ltd·Phase 1·NCT07198087·40 enrolled

Details

Drug Info

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