Treats multidrug resistant HIV-1 infection failing their current antiretroviral regimen. Sold as Trogarzo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Ibalizumab-Uiyk (sold as Trogarzo), first approved Mar 6, 2018, with 1 new use approved and 0 published complete response letters.
| Trogarzo | Part D | $12.1M | -2% | 102 |
| Trogarzo | Part B | $814K | -48% | 0 |
| A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIVHIV (Human Immunodeficiency Virus) · First Affiliated Hospital of Zhejiang University | Phase 1 | Not yet recruiting | Jun 9, 2026 |
| 10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected AdultsHIV-1-infection · David Ho | Phase 1 | Active, not recruiting | Jun 6, 2023 |
| Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)HIV-1-infection · Gilead Sciences | Phase 2 / Phase 3 | Active, not recruiting | Aug 16, 2022 |
| CD4CAR for CD4+ Leukemia and LymphomaT-cell Lymphoma, T-cell Leukemia · Huda Salman | Phase 1 | Recruiting | Feb 4, 2019 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 6, 2018 | TrogarzoBLA 761065 · New molecular entity | Theratechnologies | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
