NEW YORK, July 6, 2026
TG Therapeutics, Inc. announced the initiation of a Phase 2 clinical trial evaluating BRIUMVI® (ublituximab-xiiy) in adults with treatment-resistant schizophrenia (TRS). The open-label, multicenter study will enroll approximately 60 patients who continue to experience significant symptoms despite receiving standard antipsychotic therapy. The trial is designed to investigate whether B-cell depletion using BRIUMVI can improve psychiatric symptoms in patients whose disease may be associated with immune dysfunction and neuroinflammation. The program builds on emerging scientific evidence suggesting that immune system abnormalities may contribute to schizophrenia in a subset of patients and follows encouraging preliminary findings reported with B-cell depletion therapies in small clinical studies.
Phase 2 Study Evaluates Safety and Clinical Response
The Phase 2 trial is a single-arm, open-label study enrolling adults between 18 and 60 years of age diagnosed with treatment-resistant schizophrenia. Participants will receive intravenous BRIUMVI while continuing background standard-of-care antipsychotic treatment throughout the study. The primary endpoint will measure the proportion of patients achieving at least a 20% reduction in Positive and Negative Syndrome Scale (PANSS) total score at Week 12, a widely accepted indicator of clinical improvement in schizophrenia studies. Secondary objectives include additional efficacy assessments together with evaluations of safety, tolerability, and treatment response following B-cell depletion.
Immune Dysfunction Provides Scientific Rationale for New Treatment Approach
Although schizophrenia has traditionally been viewed as a neuropsychiatric disorder, growing research suggests that immune dysregulation and neuroinflammatory pathways may contribute to disease development in certain patients. This evolving understanding has prompted interest in therapies targeting immune cells rather than neurotransmitter pathways alone. BRIUMVI is a glycoengineered anti-CD20 monoclonal antibody designed to rapidly and efficiently eliminate CD20-expressing B cells and is currently approved for the treatment of relapsing forms of multiple sclerosis (RMS). Company leadership noted that encouraging preliminary clinical observations with the related anti-CD20 therapy rituximab in treatment-resistant schizophrenia provide additional support for investigating B-cell depletion as a novel therapeutic strategy for patients with persistent symptoms despite conventional antipsychotic medications.
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Clinical Program Expands Potential Applications for BRIUMVI
The schizophrenia study represents an important expansion of TG Therapeutics’ clinical development strategy beyond autoimmune neurological diseases. BRIUMVI has already demonstrated an established safety profile through its approved use in relapsing multiple sclerosis, where it selectively targets CD20-positive B cells involved in immune-mediated disease activity. By evaluating the therapy in treatment-resistant schizophrenia, the company aims to determine whether immune modulation can address a significant unmet medical need affecting patients who fail to respond adequately to existing treatments. If successful, the Phase 2 study could establish a new immunological treatment approach for schizophrenia and broaden the clinical utility of BRIUMVI into neuropsychiatric disorders where immune dysfunction may play a meaningful role in disease progression.
Source: TG Therapeutics press release
