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Tirabrutinib

Primary Central Nervous System Lymphoma

Explore 71 assets in Primary Central Nervous System Lymphoma →
Floatz Rating
BB66/100
Confidence
Indicative
v0.2
Sponsor
Ono Pharmaceutical Co., Ltd.
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2

Clinical Evidence

Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
58Moderate confidence
Detailed axis rationale is planned and will be published soon.
TrialPhaseStatusNPrimary endpointReadout
NCT07104032CT.gov
IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
—Recruiting———
NCT07198087CT.gov
A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants
—Active Not Recruiting———
NCT06541665CT.gov
Phase I Study Evaluating Tolerability, Safety, Pharmacokinetics, and Efficacy of Combined ONO-4059 and R-MPV Therapy for PCNSL
—Active Not Recruiting———
NCT06940791CT.gov
Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)
—Recruiting———
NCT04947319CT.gov
Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)
—Active Not Recruiting———

Competitive Position

Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
81High confidence
Detailed axis rationale is planned and will be published soon.

Same indication · Primary Central Nervous System Lymphoma

AssetSponsorPhaseRating
Tirabrutinib (this asset)Ono Pharmaceutical Co., Ltd.P3BB · 66
EtoposideFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyP4BBB
(+)-VincristineOno Pharmaceutical Co., Ltd.P4BBB
OrelabrutinibThe First Affiliated Hospital with Nanjing Medical UniversityP3BB
AdriamycinJuan P. Alderuccio, MDP4BB
IdarubicinFederal Research Institute of Pediatric Hematology, Oncology and ImmunologyP4BB
CyclophosphamideJuan P. Alderuccio, MDP4BB
CytarabineThe Lymphoma Academic Research OrganisationP4BB
RituximabOno Pharmaceutical Co., Ltd.P4BB

+42 more in the Primary Central Nervous System Lymphoma cohort

Other indications for Tirabrutinib

IndicationSponsorPhaseRating
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma—P2CCC · 54
Non-Hodgkin Lymphoma—P1CC · 47
B-Cell Chronic Lymphocytic Leukemia—P1CC · 46

Scientific Foundation

Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR

Planned for methodology v0.2.

Development Feasibility

How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR

Planned for methodology v0.2.

Commercial Opportunity

Commercial prize: addressable population, unmet need, and the value case for the indication.
NR

Planned for methodology v0.2.

IP & Exclusivity

Exclusivity position, covering patent protection and freedom-to-operate runway.
NR

Planned for methodology v0.2.

Manufacturing & Supply

Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR

Planned for methodology v0.2.

Related assets

Citation

Floatz Terminal. Tirabrutinib in Primary Central Nervous System Lymphoma. Methodology v0.2.
Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026.
Accessed July 14, 2026.
https://terminal.floatz.ai/assets/tirabrutinib-primary-central-nervous-system-lymphoma

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