ibalizumab   Click here for help

GtoPdb Ligand ID: 10208

Synonyms: Hu5A8 | ibalizumab-uiyk | TMB-355 | TMB355 | TNX-355 | Trogarzo®
Approved drug Immunopharmacology Ligand
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 ) [1]. 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 [5].
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.
No information available.
Summary of Clinical Use Click here for help
Following successful Phase 3 clinical trial (NCT02475629 [3]) 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 Click here for help
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 [1].
Clinical Trials
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.