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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:
    7d
    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)
    29d
    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)
    1m
    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)
    2ms
    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)
    3ms
    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)
    4ms
    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)
    6ms
    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)
    6ms
    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)
    8ms
    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)
    9ms
    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
    New trial
    |
    Briumvi (ublituximab-xiiy)