Ublituximab

Drug Profile

Ublituximab

Alternative Names: EMAB-6; LFB-R603; R603; TG-1101; TGTX-1101; Utuxin

Latest Information Update: 23 Oct 2017

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At a glance

  • Originator LFB Biotechnologies; rEVO Biologics
  • Developer Johns Hopkins University; LFB Biotechnologies; TG Therapeutics Inc
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action CD antigen modulators
  • Orphan Drug Status

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

    Yes - Neuromyelitis optica; Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma; Diffuse large B cell lymphoma; MALT lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Chronic lymphocytic leukaemia; Multiple sclerosis
  • Phase II Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma
  • Phase I/II Non-Hodgkin's lymphoma
  • Phase I Neuromyelitis optica

Most Recent Events

  • 16 Oct 2017 TG Therapeutics announces intention to submit accelerated NDA/BLA to the US FDA for Chronic lymphocytic leukaemia (Combination therapy with umbralisib) in second half of 2018
  • 16 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 Updated efficacy and adverse events data from a phase IIa trial in Multiple sclerosis released by TG Therapeutics
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