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Trogarzo FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 12, 2022.

FDA Approved: Yes (First approved March 6, 2018)
Brand name: Trogarzo
Generic name: ibalizumab-uiyk
Dosage form: Injection
Company: TaiMed Biologics USA Corp.
Treatment for: HIV Infection

Trogarzo (ibalizumab-uiyk) is a CD4-directed post-attachment HIV-1 inhibitor for the treatment of multidrug resistant human immunodeficiency virus-1 (HIV-1) infection.

  • Trogarzo is used in combination with other antiretroviral(s) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
  • Trogarzo is a recombinant humanized monoclonal antibody that works to block HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells and preventing the viral transmission that occurs via cell-cell fusion.
  • Trogarzo is administered as an intravenous infusion or intravenous push every 2 weeks.
  • Warnings and precautions associated with Trogarzo include hypersensitivity reactions (infusion-related reactions and anaphylactic reactions), immune reconstitution inflammatory syndrome (IRIS), and embryo-fetal toxicity.
  • Common adverse reactions include diarrhea, dizziness, nausea, and rash.


Development timeline for Trogarzo

Oct  3, 2022Approval Theratechnologies’ Trogarzo Approved by FDA for 30-Second Intravenous (IV) Push, Simplifying HIV Treatment for Heavily Treatment-Experienced Population
Mar  6, 2018Approval FDA Approves Trogarzo (ibalizumab-uiyk) for Treatment-Experienced Patients with Multidrug Resistant HIV

Further information

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