Last reviewed 2026-04-20 · How we verify

Trogarzo (IBALIZUMAB)

Trogarzo works by binding to the CD4 receptor on T-cells, preventing HIV from entering and infecting these cells.

At a glance

Mechanism of action

Ibalizumab-uiyk is an HIV-1 antiretroviral drug [see Microbiology (12.4)].

Approved indications

• Human immunodeficiency virus infection

Common side effects

• Diarrhea
• Dizziness
• Rash
• Nausea
• Bilirubin (>= 2.6 ULN)
• Lipase (> 3.0 ULN)
• Leukocytes (< 1.5 10^9 cells/L)
• Neutrophils (< 0.6 10^9 cells/L)
• Creatinine (> 1.8 ULN or 1.5 baseline)
• Immune reconstitution inflammatory syndrome
• Progressive multifocal leukoencephalopathy
• Hypersensitivity reactions

Key clinical trials

• Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML. (PHASE1)
• CD4CAR for CD4+ Leukemia and Lymphoma (PHASE1)
• Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant (PHASE1)
• A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab
• Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection (PHASE3)
• Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
• 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults (PHASE1)
• External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA

Patents

Primary sources

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