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    DRUG:

    Briumvi (ublituximab-xiiy)

    i
    Other names: TGTX-1101, LFB-R603, TG-1101, LFB R603, LFBR 603, LFBR-603, EMAB-6, R603, TG20
    Company:
    Ildong, LFB SA, Neuraxpharm, TG Therap
    Drug class:
    CD20 inhibitor
    Related drugs:
    5d
    Translating B-Cell and Plasma-Cell Targeting from Oncology to Autoimmunity: Modalities, Quantitative Bridging, and a Development Roadmap. (PubMed, Clin Pharmacol Ther)
    We summarize pivotal translational inflection points, from rituximab extension beyond lymphoma to approvals of ocrelizumab, ofatumumab, ublituximab, and inebilizumab in neuroimmunology. We further review plasma cell-directed and T-cell-engaging strategies for deep immune resets in refractory disease, while clarifying implications for trial design, long-term safety, and implementation. Finally, we introduce a model-informed roadmap integrating population PK/PD, exposure-response, and quantitative systems pharmacology to optimize indication selection, patient enrichment, and dose/regimen design-supporting confident extrapolation rather than empiricism.
    Review • Journal • IO biomarker
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    CD20 (Membrane Spanning 4-Domains A1)
    |
    Rituxan (rituximab) • Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab) • Uplizna (inebilizumab-cdon)
    26d
    ENABLE: A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov)
    P=N/A, N=2000, Recruiting, TG Therapeutics, Inc. | N=500 --> 2000 | Trial completion date: Jul 2027 --> Apr 2032 | Trial primary completion date: Jul 2027 --> Apr 2032
    Enrollment change • Trial completion date • Trial primary completion date • Real-world evidence
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    Briumvi (ublituximab-xiiy)
    1m
    Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis (clinicaltrials.gov)
    P=N/A, N=30, Recruiting, University of Maryland, Baltimore | Not yet recruiting --> Recruiting | Trial completion date: Jun 2027 --> Jan 2028 | Trial primary completion date: Mar 2027 --> Dec 2027
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    1m
    Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis (clinicaltrials.gov)
    P4, N=50, Recruiting, Johns Hopkins University | Not yet recruiting --> Recruiting
    Enrollment open
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    Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab)
    2ms
    TG1101-RMS-SC201: A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability via Autoinjector Device versus Syringe in Patients with Multiple Sclerosis (2025-523757-33-00)
    P1/2, N=120, Not yet recruiting, Tg Therapeutics Inc.
    New P1/2 trial
    |
    Briumvi (ublituximab-xiiy)
    2ms
    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) (clinicaltrials.gov)
    P3, N=360, Recruiting, TG Therapeutics, Inc.
    Trial initiation date • Head-to-Head
    |
    Briumvi (ublituximab-xiiy)
    2ms
    Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov)
    P2/3, N=240, Not yet recruiting, TG Therapeutics, Inc. | N=48 --> 240
    Enrollment change • Trial initiation date
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    Briumvi (ublituximab-xiiy) • fingolimod
    2ms
    Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov)
    P2/3, N=48, Not yet recruiting, TG Therapeutics, Inc.
    New P2/3 trial
    |
    Briumvi (ublituximab-xiiy) • fingolimod
    2ms
    A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov)
    P2, N=350, Not yet recruiting, TG Therapeutics, Inc.
    New P2 trial
    |
    Briumvi (ublituximab-xiiy)
    2ms
    Ocular toxicity associated with anti-CD20 monoclonal antibodies: A pharmacovigilance analysis using the FAERS database. (PubMed, Mult Scler Relat Disord)
    Anti-CD20 antibodies require careful ocular monitoring, particularly in multiple sclerosis patients. The elevated blepharospasm risks with ofatumumab and dyschromatopsia with rituximab highlights potential CNS-and optic pathway-related effects that warrant further study to improve MS treatment safety.
    Journal • Adverse events
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    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab)
    3ms
    SUMMIT: Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy (clinicaltrials.gov)
    P2, N=30, Recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting --> Recruiting | Trial completion date: Jun 2030 --> Aug 2029 | Trial primary completion date: Jun 2029 --> Aug 2028
    Enrollment open • Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    4ms
    TG1101-RMS-PED304: Ublituximab in Pediatric Participants with Relapsing forms of Multiple Sclerosis (RMS) (2025-522257-19-00)
    P2/3, N=40, Not yet recruiting, Tg Therapeutics Inc.
    New P2/3 trial
    |
    Briumvi (ublituximab-xiiy) • fingolimod