Tirabrutinib hydrochloride is under clinical development by Ono Pharmaceutical and currently in Phase II for Primary CNS Lymphoma. According to GlobalData, Phase II drugs for Primary CNS Lymphoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Tirabrutinib hydrochloride LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tirabrutinib hydrochloride overview

Tirabrutinib hydrochloride (Velexbru) is a antineoplastic agent. It is formulated as film coated tablet for oral route of administration. Velexbru is indicated for the treatment of recurrent or refractory primary central nervous system, Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma

Tirabrutinib hydrochloride (ONO-4059, ONO-WG-307, GS-4059) is under development for the treatment of systemic sclerosis, relapsed or refractory primary central nervous system lymphoma (PCNSL), relapsed/refractory non-Hodgkin lymphomas such as follicular lymphoma, mantle cell lymphoma, diffuse large b-cell lymphoma, marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), relapsed or refractory chronic lymphocytic leukemia, primary central nervous system lymphoma,  and chronic spontaneous urticaria (CSU). The new chemical entity is formulated as tablet or capsule which is administered orally and targets bruton’s tyrosine kinase (Btk).

It was also under development for the treatment of rheumatoid arthritis, Sjogren syndrome, pemphigus, B-cell chronic lymphocytic leukemia and autoimmune disorders.

Ono Pharmaceutical overview

Ono Pharmaceutical focuses on the research, development, manufacture and sale of prescription pharmaceuticals and diagnostic reagents. Its product portfolio includes medicines for the treatment of type II diabetes, overactive bladder, osteoporosis, cancer, chemotherapy-induced nausea and vomiting, osteoporosis, Alzheimer’s disease, peripheral circulatory disorder, bronchial asthma and allergic rhinitis, among others. The company offers products in various formulations such as capsules, patches, dry syrup, tablets, injections, and intravenous infusions. Ono Pharmaceutical has three manufacturing facilities; Joto Product Development Center, Yamaguchi Plant, and Fujiyama Plant. It offers products in the Americas, Europe, and Asia. Ono Pharmaceutical is headquartered in Osaka, Japan.

For a complete picture of Tirabrutinib hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.