TROGARZO (ibalizumab-uiyk)
TROGARZO is indicated for the treatment of Human Immunodeficiency Virus Infection.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-03-06
- Patent Cliff
- 2025
- 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
TROGARZO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03913195 results posted | TMB-302 | Ph 3 | completed | Study of the Safety of Trogarzo™ Administered as an Undiluted "IV Push" or an Intramuscular Injection |
| NCT02707861 results posted | TMB-311 | Ph 3 | completed | Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 |
| NCT02475629 results posted | TMB-301 | Ph 3 | completed | Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV |
| NCT00784147 TMB-202 results posted | TMB-202 Amendment 2 | Ph 2 | completed | Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 |
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
Indications & Usage
FDA Label (PDF)TROGARZO is indicated for the treatment of Human Immunodeficiency Virus Infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment