Drugs / ibalizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Trogarzo | — | 2023-01-01 | europa.eu ↗ |
| Label expansion | US (FDA) | TROGARZO | — | 2022-10-03 | fda.gov ↗ |
| Approved | EU (EMA) | Trogarzo | — | 2019-09-26 | europa.eu ↗ |
| Approved | US (FDA) | TROGARZO | — | 2018-03-06 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01292174 | Feb 2011 → Sep 2012 | — | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01056393 | Nov 2009 → Dec 2016 | HIV infectious disease | Kaiser Permanente | Completed | No outcome recorded |
| Phase 2 | NCT00089700 | Mar 2004 → ? | HIV infectious disease | Tanox | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03913195 | May 2019 → Oct 2022 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02707861 | Mar 2016 → Nov 2018 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02475629 | Aug 2015 → Oct 2016 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02028819 | Jan 2012 → Feb 2014 | HIV infectious disease | University of Colorado, Denver | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00784147 Comparator | Aug 2008 → Apr 2011 | HIV infectious disease | TaiMed Biologics Inc. | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ibalizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01292174 ↗ |
| Known as | HU5A8 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743029 ↗ |
| Known as | ibalizumab-uiyk | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03913195 ↗ |
| Known as | TNX-355 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00089700 ↗ |
| Known as | Trogarzo | ChEMBL registry synonym — accepted as the source's own label CHEMBL1743029 ↗ |
| Action | Inhibit | “suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes” NCT02028819 ↗ |
| Modality | Monoclonal antibody | “ibalizumab, is a humanized IgG4 monoclonal antibody administered via intravenous infusion” NCT00784147 ↗ |
| Route | Intravenous | “intravenous infusions of TNX-355, 15 mg/kg” NCT00089700 ↗ |
| Target | CD4 | “directed against a human T-cell receptor (CD4)” NCT02028819 ↗ |