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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:
    2d
    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)
    4d
    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)
    4d
    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
    |
    Briumvi (ublituximab-xiiy) • fingolimod
    6d
    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
    7d
    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)
    11d
    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
    |
    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    Rituxan (rituximab) • Gazyva (obinutuzumab) • Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab)
    27d
    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)
    2ms
    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
    2ms
    U-PACE: Effects of Ublituximab on Motor Functions in Multiple Sclerosis (clinicaltrials.gov)
    P1, N=25, Recruiting, Georgia State University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Briumvi (ublituximab-xiiy)
    2ms
    Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis (clinicaltrials.gov)
    P4, N=50, Not yet recruiting, Johns Hopkins University
    New P4 trial
    |
    Briumvi (ublituximab-xiiy) • Ocrevus (ocrelizumab)
    2ms
    An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis (clinicaltrials.gov)
    P3, N=1100, Active, not recruiting, TG Therapeutics, Inc. | Trial completion date: Feb 2030 --> May 2032 | Trial primary completion date: Feb 2030 --> May 2032
    Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)
    2ms
    ENHANCE: Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab (clinicaltrials.gov)
    P3, N=800, Recruiting, TG Therapeutics, Inc. | Trial completion date: Sep 2026 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Briumvi (ublituximab-xiiy)