Overview
CD20, an antigen expressed by various B and T cells, is an attractive therapeutic target in various cancers and autoimmune conditions. Monoclonal antibodies for B cell depletion rely on their binding affinity and ability to clear bound cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), mediated by interactions between an antibody and Fcγ receptors on natural killer cells or macrophages. Ublituximab is a chimeric anti-CD20 IgG1κ antibody produced in the rat YB2/0 cell line to target a unique epitope and enhance ADCC compared to other approved anti-CD20 antibodies such as rituximab, ofatumumab, obinutuzumab, and ocrelizumab. Ublituximab was initially developed by LFB Group but was licensed to TG Therapeutics in 2012. It has been investigated for use in numerous B cell-dependent conditions, including chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and relapsing multiple sclerosis. In December 2022, ublituximab was approved by the US FDA for the treatment of relapsing forms of multiple sclerosis, becoming the first and only anti-CD20 monoclonal antibody for multiple sclerosis allowing for administration in a one-hour infusion twice-a-year following the starting dose. The next year, June 2023, ublituximab was also approved by the EMA for the treatment of relapsing forms of multiple sclerosis in adult patients.
Indication
Ublituximab is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease by the FDA. It is also indicated by the EMA to treat relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Associated Conditions
- Clinically Isolated Syndrome (CIS)
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Active Secondary Progressive Multiple Sclerosis (SPMS)
- Relapsed Multiple sclerosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/07 | Not Applicable | Not yet recruiting | |||
2024/11/08 | N/A | Recruiting | Neurology Center of New England P.C. | ||
2024/10/07 | Early Phase 1 | Not yet recruiting | |||
2023/05/26 | Phase 3 | Recruiting | |||
2021/03/05 | Phase 2 | Active, not recruiting | City of Hope Medical Center | ||
2020/12/31 | Phase 1 | Terminated | |||
2020/11/12 | Phase 2 | Active, not recruiting | Jennifer R. Brown, MD, PhD | ||
2020/08/11 | Phase 2 | Completed | |||
2019/11/04 | Phase 2 | Terminated | |||
2019/10/18 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| TG Therapeutics, Inc. | 73150-150 | INTRAVENOUS | 150 mg in 6 mL | 1/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/31/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BRIUMVI ublituximab 150 mg/6 mL concentrated injection for infusion vial | 453648 | Medicine | A | 6/11/2025 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BRIUMVI 150 MG CONCENTRADO PARA SOLUCION PARA PERFUSION | 1231730001 | CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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