Umbralisib tosylate is under clinical development by TG Therapeutics and currently in Phase I for Post-Polycythemia Vera Myelofibrosis (PPV-MF). According to GlobalData, Phase I drugs for Post-Polycythemia Vera Myelofibrosis (PPV-MF) have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Umbralisib tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.

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.

For a complete picture of Umbralisib tosylate’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.