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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:
    4d
    Cellular and humoral vaccination response under immunotherapies-German consensus on vaccination strategies in neurological autoimmune diseases. (PubMed, Ther Adv Neurol Disord)
    The specific humoral and cellular response to vaccination can be compromised under alemtuzumab, azathioprine, cladribine, cyclophosphamide, CD19/CD20 antibodies (inebilizumab, ocrelizumab, ofatumumab, rituximab, ublituximab), dimethyl fumarate/diroximel fumarate, FcRn inhibitors (efgartigimod, rozanolixizumab), complement C5 inhibitors (eculizumab, ravulizumab, zilucoplan), interleukin-6 receptor antibodies (tocilizumab, satralizumab), intravenous immunoglobulins, long-term steroid administration, methotrexate, mitoxantrone, mycophenolate mofetil, tacrolimus, teriflunomide, tumor necrosis factor-α blockers, and sphingosine-1-phosphate receptor modulators (fingolimod, ozanimod, ponesimod, siponimod), as well as after autologous stem cell transplantation...However, the humoral and cellular vaccination response may be impaired under immunotherapy necessitating close monitoring. Here, we provide applicable recommendations to optimize immunization for individuals receiving immunotherapy due to a neurological autoimmune disease.
    Journal
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    IL6R (Interleukin 6 receptor)
    |
    Rituxan (rituximab) • cyclophosphamide • methotrexate • Campath (alemtuzumab) • mitoxantrone • cladribine • Arzerra (ofatumumab) • Briumvi (ublituximab-xiiy) • fingolimod • Actemra IV (tocilizumab) • Ocrevus (ocrelizumab) • Uplizna (inebilizumab-cdon)
    20d
    ENHANCE: Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (clinicaltrials.gov)
    P3, N=800, Recruiting, TG Therapeutics, Inc. | N=600 --> 800 | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Mar 2026 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    1m
    Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis (clinicaltrials.gov)
    P4, N=40, Not yet recruiting, Northwestern University
    New P4 trial
    |
    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.
    New P2/3 trial
    |
    Briumvi (ublituximab-xiiy) • fingolimod
    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.
    New P3 trial • Head-to-Head
    |
    Briumvi (ublituximab-xiiy)
    3ms
    Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis (clinicaltrials.gov)
    P=N/A, N=30, Not yet recruiting, University of Maryland, Baltimore | Initiation date: Jun 2025 --> Jan 2026
    Trial initiation date
    |
    Briumvi (ublituximab-xiiy)
    4ms
    DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov)
    P4, N=800, Active, not recruiting, The Cleveland Clinic | Trial completion date: Sep 2030 --> Jul 2027
    Trial completion date
    |
    Rituxan (rituximab) • Briumvi (ublituximab-xiiy) • fingolimod • Lemtrada (alemtuzumab) • Ocrevus (ocrelizumab) • Tysabri (natalizumab)
    5ms
    SUMMIT: Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID)
    New P2 trial
    |
    Briumvi (ublituximab-xiiy)
    7ms
    PROVIDE: A Study Evaluating the Presence and Concentration of BRIUMVI™ (Ublituximab) in Breast Milk (clinicaltrials.gov)
    P=N/A, N=16, Recruiting, TG Therapeutics, Inc. | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    7ms
    ENHANCE: Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (clinicaltrials.gov)
    P3, N=600, Recruiting, TG Therapeutics, Inc. | N=300 --> 600
    Enrollment change
    |
    Briumvi (ublituximab-xiiy)
    7ms
    ENHANCE: Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (clinicaltrials.gov)
    P3, N=300, Recruiting, TG Therapeutics, Inc. | Trial completion date: Jun 2026 --> Mar 2026 | Trial primary completion date: Jun 2026 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    9ms
    A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS) (clinicaltrials.gov)
    P=N/A, N=728, Recruiting, TG Therapeutics, Inc. | Trial completion date: Jun 2025 --> Mar 2035 | Trial primary completion date: Jun 2025 --> Mar 2035
    Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)