Umbralisib tosylate is under clinical development by Rhizen Pharmaceuticals and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Umbralisib tosylate’s likelihood of approval (LoA) and phase transition for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) took place on 25 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 25 Nov 2022 increased Umbralisib tosylate’s LoA and PTSR for Post-Polycythemia Vera Myelofibrosis (PPV-MF).

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Umbralisib tosylate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Rhizen Pharmaceuticals overview

RhizenPharmaceuticals (RhizenPharma), a subsidiary of Alembic Pharmaceuticals Ltd, is a biopharmaceutical company that discovers and develops small molecule drugs. The company’s research products include c-Met inhibitors, selective P13K inhibitors, CRAC channel inhibitors and GPR 119 agonist. It conducts research in the therapeutic areas of oncology, immune inflammation and metabolic disorders such as diabetes and obesity. RhizenPharma’s products find application in the treatment of diseases such as solid tumors, B cell lymphomas, hematological malignancies, asthma, diabetes and chronic obstructive pulmonary disease, among others. It collaborates with other pharmaceutical companies. Rhizenis headquartered in La Chaux-de-Fonds, Switzerland.

Quick View Umbralisib tosylate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Umbralisib tosylate
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.