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Synonyms: Hu5A8 | ibalizumab-uiyk | TMB-355 | TMB355 | TNX-355 | Trogarzo®
ibalizumab is an approved drug (FDA (2018), EMA (2019))
Compound class: Antibody
Comment: Ibalizumab was originally reported as anti-CD4 monoclonal antibody 5A8 by Burkly et al. (1992 ) . It is a non-immunosuppressive, humanised monoclonal antibody that acts as an HIV entry inhibitor [2,4]. Anti-HIV activity of TNX-355 (later to be assigned the INN ibalizumab) in patients was reported in 2004 .
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.
|No information available.|
|Summary of Clinical Use|
|Following successful Phase 3 clinical trial (NCT02475629 ) ibalizumab (Trogarzo®) was granted FDA approval in March 2018 for the treatment of HIV patients with limited treatment options (e.g. who are heavily treatment-experienced and/or have multidrug resistant HIV-1). EMA Approval followed in September 2019.|
|Mechanism Of Action and Pharmacodynamic Effects|
|Ibalizumab acts as a post-attachment inhibitor that blocks HIV from binding to the CCR5 and CXCR4 co-receptors after it has bound to its primary T cell target CD4 .|
|Clinical Trial ID||Title||Type||Source||Comment||References|
|NCT02475629||Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV||Phase 3 Interventional||TaiMed Biologics Inc.|