BRIUMVI

(Ublituximab)

ApprovedMonoclonal antibody

BRIUMVI is a monoclonal antibody that works as a B-Lymphocyte Antigen CD20 Binding Agent.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

BRIUMVI is one of 142 small molecule programs targeting Down syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

141

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Down SyndromeNot yet recruiting

Chronic Progressive Multiple SclerosisUnknown

Relapsing-Remitting Multiple SclerosisUnknown

Multiple SclerosisNot yet recruiting

SchizophreniaRecruiting

Relapsing Multiple SclerosisActive, not recruiting

RelapseActive, not recruiting

Multiple Sclerosis (MS) - Relapsing-RemittingRecruiting

Down SyndromePhase 2

Not yet recruiting

Chronic Progressive Multiple SclerosisPreclinical

Unknown

Relapsing-Remitting Multiple SclerosisPreclinical

Unknown

Multiple SclerosisApproved

Not yet recruiting

SchizophreniaPhase 2

Recruiting

Relapsing Multiple SclerosisPhase 3

Active, not recruiting

RelapsePhase 2

Active, not recruiting

Multiple Sclerosis (MS) - Relapsing-RemittingPreclinical

Recruiting

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

BRIUMVI

TTG Therapeutics, Inc.

Approved

1 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Inapsine

Jazz Pharmaceuticals

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

Preclinical

1 10

Rapamune

PPrism Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Multiple Sclerosis

NCT06629428

Q1 2027

Phase 3Recruiting

Relapsing Multiple Sclerosis

NCT05877963

Q3 2027

Phase 2Active, not recruiting

Mantle Cell Lymphoma

NCT04783415

Recruiting

Multiple Sclerosis

NCT06681623

Q1 2028

Phase 2Active, not recruiting

Relapse

NCT04624633

PreclinicalRecruiting

Multiple Sclerosis (MS) - Relapsing-Remitting

NCT06864936

Clinical

Trials by Indication[1]

Multiple Sclerosis8 trials

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

Recruiting·NNorthwestern University·Phase 4·NCT07225361·40 enrolled

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Completed·TTG Therapeutics, Inc.·Phase 3·NCT03277248·545 enrolled

A Single-Center Study to Characterize the Safety and Efficacy of Ublituximab in Older Adults With Relapsing Forms of Multiple Sclerosis (RMS)

Recruiting·NNeurology Center of New England P.C.··NCT06681623·20 enrolled

Show 5 more trials

Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

Completed·TTG Therapeutics, Inc.·Phase 2·NCT02738775·49 enrolled

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

Completed·TTG Therapeutics, Inc.·Phase 3·NCT03277261·549 enrolled

Effects of Ublituximab on Motor Functions in Multiple Sclerosis

Recruiting·GGeorgia State University·Phase 1·NCT06629428·25 enrolled

Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis

Not yet recruiting·JJohns Hopkins University·Phase 4·NCT07389590·50 enrolled

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

Recruiting·TTG Therapeutics, Inc.·Phase 2·NCT07503873·350 enrolled

Chronic Lymphocytic Leukemia4 trials

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

Terminated·TTG Therapeutics, Inc.·Phase 3·NCT02612311·603 enrolled

Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT04016805·41 enrolled

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Completed·TTG Therapeutics, Inc.·Phase 3·NCT02301156·126 enrolled

Show 1 more trial

Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

Terminated·TTG Therapeutics, Inc.·Phase 1·NCT04806035·21 enrolled

Relapsing Multiple Sclerosis4 trials

An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple Sclerosis

Active, not recruiting·TTG Therapeutics, Inc.·Phase 3·NCT04130997·1,100 enrolled

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Recruiting·TTG Therapeutics, Inc.·Preclinical·NCT07220252·240 enrolled

Evaluating Safety, Efficacy and Pharmacokinetics of a Modified Regimen of Ublituximab (ENHANCE )

Recruiting·TTG Therapeutics, Inc.·Phase 3·NCT05877963·800 enrolled

Show 1 more trial

A Phase 3, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab Versus Intravenous Ublituximab in Patients With Multiple Sclerosis

Active, not recruiting·TTG Therapeutics, Inc.·Phase 3·NCT07211633·360 enrolled

Mantle Cell Lymphoma3 trials

Lenalidomide, Umbralisib, and Ublituximab for the Treatment of Relapsed or Refractory Indolent Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Withdrawn·YYazeed Sawalha·Phase 1·NCT04635683

Clinical Trial of Ublituximab and Umbralisib With CHOP (U2-CHOP) Followed by U2 Maintenance (U2-CHOP-U2) in Previously Untreated Mantle Cell Lymphoma (MCL)

Terminated·UUniversity of Alabama at Birmingham·Phase 1/2·NCT04692155·1 enrolled

A Phase II Study of BTK Inhibitor Acalabrutinib and PI3Kδ Inhibitor Umbralisib in Combination With Ublituximab (AU2) in Patients With Previously Untreated Mantle Cell Lymphoma (MCL)

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT04783415·12 enrolled

Lymphoma3 trials

Ublituximab Followed by Response-driven Addition of Umbralisib for Treatment-naive Follicular or Marginal Zone Lymphoma

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04508647·4 enrolled

Study of TG-1801 in Subjects With B-Cell Lymphoma

Completed·TTG Therapeutics, Inc.·Phase 1·NCT03804996·50 enrolled

Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Completed·TTG Therapeutics, Inc.·Phase 1/2·NCT01647971·39 enrolled

18 more indications

Follicular Lymphoma2 trials

Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT03828448·34 enrolled

Tazemetostat in Combination With Umbralisib and Ublituximab for the Treatment Relapsed or Refractory Follicular Lymphoma

Withdrawn·—·Phase 1/2·NCT05152459

Relapsed or Refractory1 trial

Phase I/II Study of Venetoclax or Lenalidomide in Combination With Ublituximab and Umbralisib in Subjects With Relapsed or Refractory CLL/SLL and NHL

Terminated·TTG Therapeutics, Inc.·Phase 1/2·NCT03379051·78 enrolled

B-cell Malignancies1 trial

Ublituximab + Ibrutinib in Select B-cell Malignancies

Completed·TTG Therapeutics, Inc.·Phase 1/2·NCT02013128·66 enrolled

Trial1 trial

An Extension of the TG1101-RMS201 Trial

Completed·TTG Therapeutics, Inc.·Phase 2·NCT03381170·48 enrolled

Richter's Transformation1 trial

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Completed·TTG Therapeutics, Inc.·Phase 1·NCT02535286·27 enrolled

Tyrosine Kinase Inhibitor1 trial

Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies

Terminated·TTG Therapeutics, Inc.·Phase 1·NCT03671590·172 enrolled

Non-Hodgkins Lymphoma1 trial

Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma

Terminated·TTG Therapeutics, Inc.·Phase 2/3·NCT02793583·710 enrolled

Neuromyelitis Optica1 trial

Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses

Completed·JJohns Hopkins University·Phase 1·NCT02276963·6 enrolled

B-cell Lymphoid Malignancies1 trial

Ublituximab in Combination With Lenalidomide in Patients With B-Cell Lymphoid Malignancies

Terminated·TTG Therapeutics, Inc.·Phase 1·NCT01744912·10 enrolled

Safety and Efficacy1 trial

A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

Terminated·TTG Therapeutics, Inc.·Phase 2·NCT02656303·116 enrolled

Efficacy and Safety1 trial

Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)

Terminated·TTG Therapeutics, Inc.·Phase 2/3·NCT03801525·277 enrolled

Relapse1 trial

Acalabrutinib, Umbralisib, and Ublituximab (AU2) In Relapsed and Untreated CLL

Active, not recruiting·—·Phase 2·NCT04624633·29 enrolled

CLL1 trial

Umbralisib Plus Ublituximab (U2) in Progressive CLL After Novel Therapy

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT04149821·1 enrolled

Schizophrenia1 trial

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Recruiting·TTG Therapeutics, Inc.·Phase 2·NCT07680946·60 enrolled

Myasthenia Gravis1 trial

A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis

Recruiting·TTG Therapeutics, Inc.·Phase 2·NCT07673744·120 enrolled

Down syndrome1 trial

An Open-Label Phase II Feasibility Study for the Use of Ublituximab in Adults With Down Syndrome Regression Disorder

Not yet recruiting·JJonathan Santoro·Phase 2·NCT07812181·20 enrolled

Autoimmune Disorders1 trial

Study of Ublituximab in Early, Active, Autoantibody-Positive, IMMune-MedIated NecroTizing Myopathy (AIM01)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT07103746·30 enrolled

Multiple Sclerosis (MS) - Relapsing-remitting1 trial

Exploration of Novel Imaging Biomarkers on OCT for Ublituximab Treatment Response in Multiple Sclerosis

Recruiting·UUniversity of Maryland, Baltimore·Preclinical·NCT06864936·30 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 28, 2022

BRIUMVI

BLA BLA761238

Sources

References

[1]
ClinicalTrials.gov — 41 trial records for Ublituximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ublituximab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ublituximab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761238). U.S. Food & Drug Administration.
[5]
SEC EDGAR — TG Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD20 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: TTG Therapeutics, Inc.

BRIUMVI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q1 2028

Trials by Indication[1]

Multiple Sclerosis8 trials

Chronic Lymphocytic Leukemia4 trials

Relapsing Multiple Sclerosis4 trials

Mantle Cell Lymphoma3 trials

Lymphoma3 trials

Follicular Lymphoma2 trials

Relapsed or Refractory1 trial

B-cell Malignancies1 trial

Trial1 trial

Richter's Transformation1 trial

Tyrosine Kinase Inhibitor1 trial

Non-Hodgkins Lymphoma1 trial

Neuromyelitis Optica1 trial

B-cell Lymphoid Malignancies1 trial

Safety and Efficacy1 trial

Efficacy and Safety1 trial

Relapse1 trial

CLL1 trial

Schizophrenia1 trial

Myasthenia Gravis1 trial

Down syndrome1 trial

Autoimmune Disorders1 trial

Multiple Sclerosis (MS) - Relapsing-remitting1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News