Tirabrutinib hydrochloride is a Small Molecule owned by Ono Pharmaceutical, and is involved in 23 clinical trials, of which 15 were completed, and 8 are ongoing.

Tirabrutinib covalently binds to Bruton’s tyrosine kinase (BTK), a cytoplasmic tyrosine kinase and member of the Tec family of kinases, which plays an important role in B lymphocyte development, activation, signaling, proliferation and survival. The binding of tirabrutinib  to BTK within B cells, thereby prevents the B cell receptor signaling and impeding B cell development. This results in inhibition of proliferation of B cell malignancies.

The revenue for Tirabrutinib hydrochloride is expected to reach a total of $1.8bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Tirabrutinib hydrochloride NPV Report.

Tirabrutinib hydrochloride is originated and owned by Ono Pharmaceutical. Gilead Sciences is the other company associated in development or marketing of Tirabrutinib hydrochloride.

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, tablets, injections, patches, dry syrup 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.

The company reported revenues of (Yen) JPY361,361 million for the fiscal year ended March 2022 (FY2022), an increase of 16.8% over FY2021. In FY2022, the company’s operating margin was 28.6%, compared to an operating margin of 31.8% in FY2021. In FY2022, the company recorded a net margin of 22.3%, compared to a net margin of 24.4% in FY2021. The company reported revenues of JPY109,979 million for the second quarter ended September 2022, an increase of 3.1% over the previous quarter.

Quick View – Tirabrutinib hydrochloride

Report Segments
  • Innovator (NME)
Drug Name
  • Tirabrutinib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Dermatology
  • Immunology
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.