Success Metrics

Clinical Success Rate
85.7%

Based on 6 completed trials

Completion Rate
86%(6/7)
Active Trials
4(33%)
Results Posted
117%(7 trials)
Terminated
1(8%)

Phase Distribution

Ph phase_1
5
42%
Ph phase_3
1
8%
Ph phase_2
6
50%

Phase Distribution

5

Early Stage

6

Mid Stage

1

Late Stage

Phase Distribution12 total trials
Phase 1Safety & dosage
5(41.7%)
Phase 2Efficacy & side effects
6(50.0%)
Phase 3Large-scale testing
1(8.3%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

75.0%

6 of 8 finished

Non-Completion Rate

25.0%

2 ended early

Currently Active

4

trials recruiting

Total Trials

12

all time

Status Distribution
Active(4)
Completed(6)
Terminated(2)

Detailed Status

Completed6
Active, not recruiting2
Recruiting2
Terminated1
Withdrawn1

Development Timeline

Analytics

Development Status

Total Trials
12
Active
4
Success Rate
85.7%
Most Advanced
Phase 3

Trials by Phase

Phase 15 (41.7%)
Phase 26 (50.0%)
Phase 31 (8.3%)

Trials by Status

completed650%
active_not_recruiting217%
terminated18%
recruiting217%
withdrawn18%

Recent Activity

Clinical Trials (12)

Showing 12 of 12 trials
NCT07104032Phase 3

IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Recruiting
NCT07198087Phase 1

A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants

Active Not Recruiting
NCT04947319Phase 2

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

Active Not Recruiting
NCT02457598Phase 1

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

Terminated
NCT06940791Phase 2

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

Recruiting
NCT02457559Phase 1

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

Completed
NCT02968563Phase 2

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
NCT02983617Phase 2

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

Completed
NCT04827589Phase 2

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

Withdrawn
NCT01659255Phase 1

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

Completed
NCT03100942Phase 2

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

Completed
NCT02626026Phase 1

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

Completed

All 12 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
12