Umbralisib

Drug Profile

Umbralisib

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

Latest Information Update: 23 Oct 2017

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At a glance

  • Originator Incozen Therapeutics; Rhizen Pharmaceuticals
  • Developer Columbia University Medical Center; TG Therapeutics Inc; Vanderbilt-Ingram Cancer Center
  • Class Antineoplastics; Benzopyrans; Pyrazoles; Pyrimidines; Small molecules
  • Mechanism of Action Casein kinase Iepsilon 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
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chronic lymphocytic leukaemia
  • Phase II Diffuse large B cell lymphoma; Follicular lymphoma; MALT lymphoma
  • Phase I Hodgkin's disease; Mantle-cell lymphoma; Myelofibrosis; Non-Hodgkin's lymphoma; Polycythaemia vera; Solid tumours
  • Research Multiple sclerosis

Most Recent Events

  • 23 Oct 2017 TG Therapeutics completes enrolment in its phase III UNITY-CLL trial for Chronic lymphocytic leukaemia (Combination therapy, First-line therapy, Second-line therapy or greater) in USA, Poland and United Kingdom (NCT02612311)
  • 16 Oct 2017 TG Therapeutics announces intention to submit accelerated NDA/BLA to the US FDA for Chronic lymphocytic leukaemia (Combination therapy with ublituximab) in second half of 2018
  • 29 Sep 2017 Early research in Multiple sclerosis in USA (PO)
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