Ibalizumab
drugOn this page
Also known as HU5A8Ibalizumab-uiykTNX-355Trogarzo
Summary
Ibalizumab (CHEMBL1743029) is an approved antibody (ATC J05AX23) targeting CD4; indicated across 4 conditions including hiv infectious disease and viral infectious disease.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: J05AX23
- Targets: 1 (CD4)
- Indications: 4 conditions
- Clinical trials: 7
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1743029 |
| Name | Ibalizumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | J05AX23 |
Also known as: HU5A8, Ibalizumab, Ibalizumab-uiyk, TNX-355, Trogarzo, IBALIZUMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| CD4 | CD4 | Binding | 0.1% | P01730 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): CD4.
Top Reactome pathways
32 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Cytokine Signaling in Immune system | 1 | CD4 |
| Adaptive Immune System | 1 | CD4 |
| Defensins | 1 | CD4 |
| Alpha-defensins | 1 | CD4 |
| HIV Life Cycle | 1 | CD4 |
| Early Phase of HIV Life Cycle | 1 | CD4 |
| HIV Infection | 1 | CD4 |
| Host Interactions of HIV factors | 1 | CD4 |
| Disease | 1 | CD4 |
| Nef-mediates down modulation of cell surface receptors by recruiting them to clathrin adapters | 1 | CD4 |
| The role of Nef in HIV-1 replication and disease pathogenesis | 1 | CD4 |
| Nef Mediated CD4 Down-regulation | 1 | CD4 |
| Innate Immune System | 1 | CD4 |
| Immune System | 1 | CD4 |
| Binding and entry of HIV virion | 1 | CD4 |
| Vpu mediated degradation of CD4 | 1 | CD4 |
| Membrane Trafficking | 1 | CD4 |
| TCR signaling | 1 | CD4 |
| Downstream TCR signaling | 1 | CD4 |
| Phosphorylation of CD3 and TCR zeta chains | 1 | CD4 |
| Translocation of ZAP-70 to Immunological synapse | 1 | CD4 |
| Generation of second messenger molecules | 1 | CD4 |
| Regulation of T cell activation by CD28 family | 1 | CD4 |
| Co-inhibition by PD-1 | 1 | CD4 |
| Signaling by Interleukins | 1 | CD4 |
| Other interleukin signaling | 1 | CD4 |
| Vesicle-mediated transport | 1 | CD4 |
| Infectious disease | 1 | CD4 |
| Antimicrobial peptides | 1 | CD4 |
| Cargo recognition for clathrin-mediated endocytosis | 1 | CD4 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| adaptive immune response | 1 |
| immune response | 1 |
| cell adhesion | 1 |
| signal transduction | 1 |
| cell surface receptor signaling pathway | 1 |
| enzyme-linked receptor protein signaling pathway | 1 |
| cell surface receptor protein tyrosine kinase signaling pathway | 1 |
| positive regulation of calcium ion transport into cytosol | 1 |
| calcium-mediated signaling | 1 |
| T cell differentiation | 1 |
| macrophage differentiation | 1 |
| response to estradiol | 1 |
| maintenance of protein location in cell | 1 |
| positive regulation of interleukin-2 production | 1 |
| response to vitamin D | 1 |
Indications & clinical
Indications
4 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| HIV infectious disease | 4 | MONDO:0005109 | EFO:0000764 |
| viral infectious disease | 4 | MONDO:0005108 | EFO:0000763 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 7.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 3 |
| PHASE2 | 2 |
| Not specified | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT02475629 | PHASE3 | COMPLETED | Ibalizumab Plus Optimized Background Regimen in Patient With Multi-Drug Resistant HIV |
| NCT02707861 | PHASE3 | COMPLETED | Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1 |
| NCT03913195 | PHASE3 | COMPLETED | Study of the Safety of Trogarzo™ Administered as an Undiluted IV Push or an Intramuscular Injection |
| NCT00089700 | PHASE2 | UNKNOWN | TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1 |
| NCT00784147 | PHASE2 | COMPLETED | Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1 |
| NCT02028819 | Not specified | NO_LONGER_AVAILABLE | Compassionate Use of Ibalizumab for the Treatment of HIV Infection |
| NCT05495204 | Not specified | COMPLETED | External Comparison of Ibalizumab in Trials vs. Other Regimens in OPERA |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Genes: CD4
- Diseases: HIV infectious disease, viral infectious disease