Prescription medicine
Ibalizumab Brand names: Trogarzo
Ibalizumab (Trogarzo) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the ibalizumab FDA label on DailyMed (effective January 7, 2026); every ibalizumab label on DailyMed.
Highlights of the record
FDA label of January 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTROGARZO, 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.
Forms and strengths
- 150 mg/ml
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 536 through July 30, 2026
What is ibalizumab used for?
From the label: indications and usageTROGARZO, 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.
Conditions named in the indications of ibalizumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: CD4-directed Blocking Antibody and Human Immunodeficiency Virus 1 Post-attachment Fusion Inhibitor.
Source: FDA drug label (TROGARZO), Theratechnologies Inc., effective January 7, 2026 (SPL set c548ad82-9d1f-4d16-95b6-4e6106badf43), via openFDA; the full label on DailyMed
Is there a generic for ibalizumab (Trogarzo)?
No generic ibalizumab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ibalizumab?
The FDA Adverse Event Reporting System holds 536 reports that list ibalizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 118 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ibalizumab?
1 other medicine is given the same way (intravenous) and in the same FDA class as ibalizumab or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Zidovudine | HIV | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Ibalizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other