Ublituximab
Monoclonal antibody | |
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Type | Whole antibody |
Source | Chimeric (mouse/human) |
Target | CD20 |
Clinical data | |
Trade names | Briumvi |
Other names | ublituximab-xiiy |
License data |
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Routes of administration | Intravenous |
ATC code |
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Legal status | |
Legal status | |
Identifiers | |
CAS Number | |
DrugBank | |
ChemSpider |
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UNII | |
KEGG | |
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Ublituximab, sold under the brand name Briumvi, is an immunomodulator used for the treatment of multiple sclerosis.[1] It is a CD20-directed cytolytic monoclonal antibody.[1]
It was approved for medical use in the United States in December 2022.[1][2][3]
Medical uses
Ublituximab is indicated for the treatment of relapsing forms of multiple sclerosis.[1]
Society and culture
Names
Ublituximab is the international nonproprietary name (INN).[4]
Research
It is in phase III clinical trials for multiple sclerosis.[5]
It is also in "U2" phase III clinical trials for chronic lymphocytic leukemia in combination with umbralisib.[6][7]
References
- ^ a b c d e https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf
- ^ "Briumvi: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 29 December 2022.
- ^ "TG Therapeutics Announces FDA Approval of Briumvi (ublituximab-xiiy)" (Press release). TG Therapeutics. 28 December 2022. Retrieved 29 December 2022 – via GlobeNewswire.
- ^ World Health Organization (2011). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 66". WHO Drug Information. 25 (3). hdl:10665/74683.
- ^ Clinical trial number NCT03277261 for "A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
- ^ Lunning M, Vose J, Nastoupil L, Fowler N, Burger JA, Wierda WG, et al. (November 2019). "Ublituximab and umbralisib in relapsed/refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukemia". Blood. 134 (21): 1811–1820. doi:10.1182/blood.2019002118. PMC 7042665. PMID 31558467.
- ^ Babiker HM, Glode AE, Cooke LS, Mahadevan D (April 2018). "Ublituximab for the treatment of CD20 positive B-cell malignancies". Expert Opinion on Investigational Drugs. 27 (4): 407–412. doi:10.1080/13543784.2018.1459560. PMID 29609506. S2CID 4775126.
External links
- Clinical trial number NCT03277261 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE 1)" at ClinicalTrials.gov
- Clinical trial number NCT03277248 for "Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) (ULTIMATE II)" at ClinicalTrials.gov