BRIUMVI

(Ublituximab)

Phase 3Monoclonal antibody

BRIUMVI is a monoclonal antibody that works as a B-Lymphocyte Antigen CD20 Binding Agent.[2] It is being investigated across 16 indications, with its most advanced program in Phase 3.[1]

BRIUMVI is one of 350 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

349

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Non-Hodgkins LymphomaActive, not recruiting

Nodal Marginal Zone B-Cell LymphomaActive, not recruiting

AutoimmunityActive, not recruiting

LymphomaActive, not recruiting

Type II Hypersensitivity Reaction DiseaseActive, not recruiting

MyopathyActive, not recruiting

Chronic Progressive Multiple SclerosisUnknown

Relapsing-Remitting Multiple SclerosisUnknown

Neuromyelitis OpticaActive, not recruiting

Mantle Cell LymphomaActive, not recruiting

Non-Hodgkins LymphomaPhase 2

Active, not recruiting

Nodal Marginal Zone B-Cell LymphomaPhase 1

Active, not recruiting

AutoimmunityPhase 2

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Type II Hypersensitivity Reaction DiseasePhase 2

Active, not recruiting

MyopathyPhase 2

Active, not recruiting

Chronic Progressive Multiple SclerosisPreclinical

Unknown

Relapsing-Remitting Multiple SclerosisPreclinical

Unknown

Neuromyelitis OpticaPhase 1

Active, not recruiting

Mantle Cell LymphomaPhase 1

Active, not recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

BRIUMVI

TTG Therapeutics, Inc.

Phase 3

3 2

Blenoxane

SSequus Pharmaceuticals

Preclinical

25 3

Velban

EEastern Cooperative Oncology Group

Preclinical

15 4

Tafasitamab

Incyte

Preclinical

7 5

Nuvigil

NNuvo Research GmbH

Preclinical

1 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 9

Decadron

QQuince Therapeutics S.p.A.

PEG-Intron

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

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Multiple Sclerosis

NCT06629428

Q2 2027

N/ANot yet recruiting

Multiple Sclerosis

NCT06864936

Q3 2027

Recruiting

Multiple Sclerosis

NCT06681623

Q4 2027

Phase 3Recruiting

Efficacy

NCT05877963

Clinical

Trials by Indication[1]

Multiple Sclerosis11 trials

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

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

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

Not yet recruiting·UUniversity of Maryland, Baltimore·N/A·NCT06864936·30 enrolled

Show 8 more trials

An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis

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

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)

Recruiting·TTG Therapeutics, Inc.·Phase 3·NCT07211633·360 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

Ublituximab (Briumvi) for Early Forms of Relapsing Multiple Sclerosis

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

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

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

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

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 + 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

Show 1 more trial

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

Lymphoma3 trials

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

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

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 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

Mantle Cell Lymphoma3 trials

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

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

Acalabrutinib, Umbralisib, and Ublituximab for the Treatment of Previously Untreated Mantle Cell Lymphoma

Active, not recruiting·—·Phase 2·NCT04783415·12 enrolled

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

17 more indications

B-cell Malignancies1 trial

Ublituximab + Ibrutinib in Select B-cell Malignancies

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

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

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

Trial1 trial

An Extension of the TG1101-RMS201 Trial

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

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

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

Myopathy1 trial

Ublituximab in Autoantibody Positive Immune Mediated Necrotizing Myopathy

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

Neuromyelitis Optica1 trial

Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses

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

Efficacy1 trial

Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab

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

Relapsing Multiple Sclerosis1 trial

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

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

Schizophrenia1 trial

Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia

Not yet 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

Regulatory

FDA Approval Timeline[4]

Dec 28, 2022

BRIUMVI

BLA BLA761238

Sources

References

[1]
ClinicalTrials.gov — 40 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: Phase 3[1]
Company: TTG Therapeutics, Inc.

BRIUMVI

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Multiple Sclerosis11 trials

Chronic Lymphocytic Leukemia4 trials

Lymphoma3 trials

Mantle Cell Lymphoma3 trials

Follicular Lymphoma2 trials

B-cell Malignancies1 trial

B-cell Lymphoid Malignancies1 trial

Safety and Efficacy1 trial

Richter's Transformation1 trial

Efficacy and Safety1 trial

Trial1 trial

Relapsed or Refractory1 trial

Tyrosine Kinase Inhibitor1 trial

Non-Hodgkins Lymphoma1 trial

Myopathy1 trial

Neuromyelitis Optica1 trial

Efficacy1 trial

Relapse1 trial

CLL1 trial

Relapsing Multiple Sclerosis1 trial

Schizophrenia1 trial

Myasthenia Gravis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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