Tirabrutinib

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

LymphomaRheumatoid ArthritisChronic Lymphocytic LeukemiaCentral Nervous System LymphomaChronic Spontaneous UrticariaPrimary Central Nervous System Lymphoma

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

1

Tirabrutinib

Gilead

Phase 3

12

Blenoxane

SSequus Pharmaceuticals

Preclinical

253

Oncaspar

SServier

Preclinical

154

Zofran

Novartis

Preclinical

25

Norvir

AbbVie

Preclinical

16

Wellcovorin

GGlaxo Dba Glaxosmithkline

Preclinical

47

Tafasitamab

Incyte

Preclinical

78

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—Show 20 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

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

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

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

Lymphoma1 trial

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

Recruiting·KKyorin University·Phase 2·NCT06940791·92 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Withdrawn·Gilead·Phase 2·NCT04827589

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

6 more indications

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

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

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

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

Primary Central Nervous System Lymphoma1 trial

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

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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