TROGARZO
Trogarzo (ibalizumab-uiyk) is an antiretroviral medication indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. It is used in combination with other antiretroviral therapies for adult patients who are heavily treatment-experienced. The drug is specifically intended for individuals with multidrug-resistant HIV-1 who are currently failing their existing antiretroviral regimen.
How TROGARZO Works
Trogarzo is a CD4-directed blocking antibody that functions as a post-attachment HIV-1 inhibitor. It targets the CD4 receptor on host cells to interfere with the viral infection process. By acting as a fusion inhibitor after the virus has already bound to the cell, the medication prevents HIV-1 from successfully entering and infecting the host cell.
Details
- Status
- Prescription
- First Approved
- 2018-03-06
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TROGARZO Approval History
What TROGARZO Treats
1 indicationsTROGARZO is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Human Immunodeficiency Virus Infection
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TROGARZO FDA Label Details
ProIndications & Usage
FDA Label (PDF)TROGARZO, in combination with other antiretroviral(s), is indicated 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, a CD4-directed post-attachment HIV-1 inhibitor, in combination with other antiretroviral(s), is indicated 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.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.