Product Description
Ublituximab is an investigational glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions (including antibody-dependent cellular cytotoxicity [ADCC] and complement dependent cytotoxicity [CDC]), leading to destruction of the cell. Additionally, ublituximab is uniquely designed, to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity. (Sourced from: https://www.tgtherapeutics.com/our-pipeline/ublituximab/)
Mechanisms of Action: CD20 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Fast Track - Chronic Leukemia|Chronic Lymphoid Leukemia|Leukemia|Lymphoid Leukemia *
Approval Status: Approved
Approved Countries: Croatia | Lithuania | Portugal | Sweden | United States
Approved Indications: None
Known Adverse Events: None
Company: TG Therapeutics
Company Location: NEW YORK NY 10014
Company CEO: Michael S. Weiss
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belarus, Croatia, Georgia, Poland, Russia, Serbia, Ukraine, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Multiple Sclerosis
Phase 2: Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Multiple Sclerosis, Relapsing-Remitting
Phase 1: Myasthenia Gravis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TG1101-RMS303 | P3 |
Unknown Status |
Multiple Sclerosis |
2027-09-01 |
|
| TG1101-RMS303 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2027-04-01 |
|
| TG1101-RMS-SC101 | P1 |
Unknown Status |
Myasthenia Gravis|Multiple Sclerosis |
2027-01-05 |
|
| NCT04624633 | P2 |
Active, not recruiting |
Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia |
2026-12-21 |