Ibalizumab: First Global Approval

Drugs. 2018 May;78(7):781-785. doi: 10.1007/s40265-018-0907-5.


TaiMed Biologics is developing ibalizumab (Trogarzo™, ibalizumab-uiyk)-a humanised IgG4 monoclonal antibody-as a treatment for HIV-1 infection. Ibalizumab blocks HIV entry into CD4 cells while preserving normal immunological function and is the first CD4-directed post-attachment HIV-1 inhibitor and the first humanised monoclonal antibody for the treatment of HIV/AIDS. This article summarizes the milestones in the development of ibalizumab leading to this first approval in HIV-1 treatment.

Publication types

  • Review

MeSH terms

  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • Drug Approval
  • Drug Resistance, Multiple
  • Drug Resistance, Viral
  • HIV Infections / drug therapy*
  • HIV-1 / drug effects
  • Humans
  • Immunoglobulin G / immunology


  • Anti-HIV Agents
  • Antibodies, Monoclonal
  • Immunoglobulin G
  • ibalizumab