ibalizumab-uiyk
Trade name: trogarzo
Approved
Mar 6, 2018
Ibalizumab, sold under the brand name Trogarzo, is a non-immunosuppressive humanised monoclonal antibody that binds CD4, the primary receptor for HIV, and inhibits HIV from entering cells. It is a post-attachment inhibitor, blocking HIV from binding to the CCR5 and CXCR4 co-receptors after HIV binds to the CD4 receptor on the surface of a CD4 cell. Post-attachment inhibitors are a subclass of HIV drugs called entry inhibitors. — Wikipedia
Clinical trial activity
11 trials · 7 clinical orgs · 2 marketing orgs
Earliest trial started Mar 1, 2004 (NCT00089700)
Timeline
2000s
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2011
TaiMed Biologics Inc. — Earliest Phase 1 Sponsor(trial)
- Oct 20, 2014
Orphan Drug Designation
- Jan 1, 2015
TaiMed Biologics Inc. — Earliest Phase 3 Sponsor(trial)
- Mar 6, 2018
TaiMed Biologics Inc. — Earliest FDA Approval
- Mar 6, 2018
TaiMed Biologics Inc. — Marketing Organization
- Mar 6, 2018
Theratechnologies — Marketing Organization
- Mar 6, 2018
TaiMed Biologics Inc. — NDA Organization
- Mar 6, 2018
Theratechnologies — NDA Secondary Org
Indications
Approved for
Studied for
Mechanism of action
- T-cell surface antigen CD4INHIBITOR
CD4 inhibitor
Binds to CD4 domain 2
Approval history
- approvedPriority reviewFast trackBreakthroughMar 6, 2018
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL3989925 ↗
- WikipediaIbalizumab ↗
- NCATSLT369U66CE ↗
- ChEMBLCHEMBL1743029 ↗
Also known as
- hu5a8
- hu-5a8
- ibalizumab
- ibalizumab
- ibalizumab
- ibalizumab
- ibalizumab-uiyk
- tmb-355
- tnx-355
- tnx-355
- tnx-355
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07215468 | Phase 2 | Dec 31, 2025 | TaiMed Biologics Inc. |
| NCT05275998 | Phase 1/Phase 2 (Phase 2) | Jul 5, 2022 | TaiMed Biologics Inc. |
| NCT04027387 | Phase 1 | Nov 30, 2019 | TaiMed Biologics Inc., Westat |
| NCT03913195 | Phase 3 | May 30, 2019 | TaiMed Biologics Inc., Westat |
| NCT02707861 | Phase 3 | Mar 1, 2016 | TaiMed Biologics Inc., Westat |
| NCT02475629 | Phase 3 | Aug 1, 2015 | TaiMed Biologics Inc. |
| NCT02028819 | N/A | Jan 1, 2012 | University of Colorado, Denver |
| NCT01292174 | Phase 1 | Feb 1, 2011 | Bill and Melinda Gates Foundation, Rockefeller University, TaiMed Biologics Inc. |
| NCT01056393 | Phase 2 | Nov 1, 2009 | Kaiser Permanente, TaiMed Biologics Inc. |
| NCT00784147 | Phase 2 | Aug 1, 2008 | TaiMed Biologics Inc. |
| NCT00089700 | Phase 2 | Mar 1, 2004 | Tanox |
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| TaiMed Biologics Inc. | For profit | 9 | 8 | 3 | 2008 |
| Westat | For profit | 3 | 0 | 2 | 2016 |
| Bill and Melinda Gates Foundation | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Kaiser Permanente | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Rockefeller University | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Tanox | For profit | 1 | 1 | 1 | 2004 |
| University of Colorado, Denver | Academic/Hospital | 1 | 1 | 1 | 2012 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| TaiMed Biologics Inc. | For profit | MKTG | Mar 6, 2018 |
| TaiMed Biologics Inc. | For profit | NDA | Mar 6, 2018 |
| Theratechnologies | For profit | MKTG | Mar 6, 2018 |
| Theratechnologies | For profit | NDA2 | Mar 6, 2018 |