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Ublituximab - TG Therapeutics

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Drug Profile

Ublituximab - TG Therapeutics

Alternative Names: BRIUMVI; EMAB-6; EMAB-603; LFB-R603; R603; Rituximab biobetter - TG Therapeutics; TG-1101; TG-20; TGTX-1101; Ublituximab-xiiy - TG Therapeutics; Utuxin™

Latest Information Update: 19 May 2025

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At a glance

  • Originator LFB Biotechnologies; rEVO Biologics
  • Developer Johns Hopkins University; LFB Biotechnologies; Neuraxpharm; TG Therapeutics Inc
  • Class Antineoplastics; Biobetters; Eye disorder therapies; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • 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; Diffuse large B cell lymphoma; Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Multiple sclerosis
  • Clinical Phase Unknown Myasthenia gravis
  • Preregistration Submission Withdrawal Chronic lymphocytic leukaemia
  • Discontinued Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Neuromyelitis optica; Non-Hodgkin's lymphoma; Richter's syndrome

Most Recent Events

  • 05 May 2025 Launched for Multiple sclerosis (In adults) in Switzerland (IV)
  • 10 Apr 2025 TG Therapeutics plans to initiate a registration-directed trial for Multiple sclerosis
  • 27 Feb 2025 Updated adverse events data from a phase IIIb ENHANCE trial in Multiple sclerosis presented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum (ACTRIMS - 2025)

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