| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD4 |
| Clinical data | |
| Trade names | Trogarzo |
| Other names | Ibalizumab-uiyk; TMB-355,[1] TNX-355 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a618020 |
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| Routes of administration | Intravenous (IV) |
| ATC code | |
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Ibalizumab, sold under the brand name Trogarzo, is a non-immunosuppressive humanised monoclonal antibody that binds CD4, the primary receptor for HIV,[3] and inhibits HIV from entering cells.[4] It is a post-attachment inhibitor, blocking HIV from binding to the CCR5 and CXCR4 co-receptors after HIV binds to the CD4 receptor on the surface of a CD4 cell. Post-attachment inhibitors are a subclass of HIV drugs called entry inhibitors.
On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved ibalizumab for multidrug-resistant HIV-1.[5][6] It is used in combination with other antiretroviral drugs.[5] The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]
- ^ "Ibalizumab (TMB-355)". TaiMed Biologics. 2009-09-09. Archived from the original on 2009-08-20.
- ^ "Trogarzo- ibalizumab injection, solution". DailyMed. 29 September 2021. Retrieved 21 May 2022.
- ^ Jacobson JM, Kuritzkes DR, Godofsky E, DeJesus E, Larson JA, Weinheimer SP, Lewis ST (February 2009). "Safety, pharmacokinetics, and antiretroviral activity of multiple doses of ibalizumab (formerly TNX-355), an anti-CD4 monoclonal antibody, in human immunodeficiency virus type 1-infected adults". Antimicrobial Agents and Chemotherapy. 53 (2): 450–7. doi:10.1128/AAC.00942-08. PMC 2630626. PMID 19015347.
- ^ "TNX-355 fact sheet". AIDSmeds.com. 2006-08-25.
- ^ a b "FDA approves new HIV treatment for patients who have limited treatment options". U.S. Food and Drug Administration (FDA) (Press release). 24 March 2020. Retrieved 21 May 2022.
This article incorporates text from this source, which is in the public domain.
- ^ "Drug Approval Package: Trogarzo injection (ibalizumab-uiyk)". U.S. Food and Drug Administration (FDA). 6 March 2018. Retrieved 21 May 2022.
- ^ New Drug Therapy Approvals 2018 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2019. Retrieved 16 September 2020.
