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Umbralisib - TG Therapeutics

Drug Profile

Umbralisib - TG Therapeutics

Alternative Names: RP 5307; RP-5264; TGR-1202; UKONIQ

Latest Information Update: 24 Jan 2024

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At a glance

  • Originator Incozen Therapeutics; Rhizen Pharmaceuticals
  • Developer TG Therapeutics Inc
  • Class Amines; Antineoplastics; Benzopyrans; Fluorinated hydrocarbons; Ketones; Pyrazoles; Pyrimidines; Small molecules
  • Mechanism of Action Casein kinase 1 epsilon inhibitors; Phosphatidylinositol 3 kinase delta inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Diffuse large B cell lymphoma; Chronic lymphocytic leukaemia; Follicular lymphoma; Marginal zone B-cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chronic lymphocytic leukaemia
  • Phase II/III Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
  • Phase II Hodgkin's disease; Waldenstrom's macroglobulinaemia
  • Phase I/II Non-Hodgkin's lymphoma
  • No development reported Multiple sclerosis; Myelofibrosis; Polycythaemia vera; Richter's syndrome; Solid tumours

Most Recent Events

  • 09 Dec 2023 Efficacy and adverse events data from a phase II trial in Chronic lymphocytic leukaemia presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
  • 31 Aug 2023 Dana-Farber Cancer Institute and TG Therapeutics complete a phase I trial in Chronic lymphocytic leukaemia and Mantle cell lymphoma (Combination therapy, Second-line therapy or greater) in USA (PO) (NCT02268851)
  • 28 Mar 2023 National Cancer Institute terminates the phase II trial for Follicular lymphoma (Combination therapy, Second-line therapy or greater) in USA (NCT03269669)
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