Umbralisib tosylate is a Small Molecule owned by Rhizen Pharmaceuticals, and is involved in 26 clinical trials, of which 15 were completed, 9 are ongoing, and 2 are planned.

Umbralisib tosylate (TGR-1202, RP-5307) acts by inhibiting phosphoinositide-3-kinase delta (PI3K-delta) and casein kinase I isoform epsilon. The drug candidate suppresses proliferation and Akt phosphorylation in cancer cells. Additionally, TGR-1202 also causes half-maximal inhibition of human whole blood CD19 cell proliferation.

The revenue for Umbralisib tosylate is expected to reach a total of $1.7bn 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 Umbralisib tosylate NPV Report.

Umbralisib tosylate is originated and owned by Rhizen Pharmaceuticals. TG Therapeutics is the other company associated in development or marketing of Umbralisib tosylate.

Umbralisib tosylate Overview

Umbralisib tosylate (Ukoniq) is a potent anti neoplastic agent. It is formulated as film caoted tablets for oral route of administration. Ukoniq is indicated for the treatment of adult patients with relapsed or refractory extranodal, nodal and splenic marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and  for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

It is under development for the treatment of  post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (Post-ET MF), and Waldenstrom macroglobulinemia.

Umbralisib tosylate (TGR-1202, RP-5307) was under development for the treatment of Hodgkin lymphoma, follicular lymphoma, relapsed or refractory chronic lymphocytic leukemia (CLL), relapsed/refractory chronic lymphocytic leukemia, peripheral T-cell lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, small lymphocytic lymphoma, gastrointestinal cancers such as colorectal cancer, pancreatic cancer, gastric cancer, esophageal cancer, and gastrointestinal stromal tumor. The drug candidate is administered through the oral route. The drug candidate acts by targeting phosphoinositide-3-kinase delta (PI3K-delta) and casein kinase I isoform epsilon. It was also under development for the treatment of multiple myeloma, multiple sclerosis and Hodgkin’s lymphoma.

TG Therapeutics Overview

TG Therapeutics is a biopharmaceutical company which acquires, develops and commercializes pharmaceutical products for the treatment of B-cell malignancies and various autoimmune diseases. The company’s approved products in the US include Ukoniq for the treatment of relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma. The pipeline products of the company include Ublituximab for the treatment of chronic lymphocytic leukemia (CLL) and multiple sclerosis; Umbralisib for CLL; and Cosibelimab for B-cell cancers, among others. The company also evaluates products and technologies for in-licensing, partnership, acquisition, and investment. The company has operations in the US and Australia. TG Therapeutics is headquartered in New York City, New York, the US.

The company reported revenues of (US Dollars) US$6.7 million for the fiscal year ended December 2021 (FY2021), compared to a revenue of US$0.2 million in FY2020. The operating loss of the company was US$344.8 million in FY2021, compared to an operating loss of US$273.6 million in FY2020. The net loss of the company was US$348.1 million in FY2021, compared to a net loss of US$279.4 million in FY2020. The company reported revenues of US$0.1 million for the third quarter ended September 2022, a decrease of 84.2% over the previous quarter.

Quick View – Umbralisib tosylate

Report Segments
  • Innovator (NME)
Drug Name
  • Umbralisib tosylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • 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.