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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: 07 Nov 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
  • Phase I 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

  • 03 Nov 2025 Efficacy and adverse events data from the phase III OLE trial in Multiple sclerosis released by TG Therapeutics
  • 28 Oct 2025 TG Therapeutics plans to launch a new dosing regimen for Multiple sclerosis in 2027.
  • 28 Oct 2025 TG Therapeutics completes enrolment in its phase III ENHANCE trial for Multiple sclerosis (Treatment-experienced) in the US and Poland (IV) (NCT05877963)

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