Stapokibart
drugOn this page
Also known as Cm-310CM310
Summary
Stapokibart (CHEMBL5095324) is a phase-3 clinical-stage antibody targeting IL4R; indicated across 6 conditions including atopic eczema and allergic rhinitis.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Targets: 1 (IL4R)
- Indications: 6 conditions
- Clinical trials: 34
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL5095324 |
| Name | Stapokibart |
| Type | Antibody |
| Max phase | 3 |
Also known as: Cm-310, CM310, Stapokibart, STAPOKIBART
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 |
|---|---|---|---|---|---|
| IL4R | Interleukin-4 receptor subunit α | Antagonist | 9.4 | 0.4% | P24394 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): IL4R.
Top Reactome pathways
2 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Interleukin-4 and Interleukin-13 signaling | 1 | IL4R |
| Differentiation of naive CD4+ T cells to T helper 2 cells (Th2 cells) | 1 | IL4R |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| production of molecular mediator involved in inflammatory response | 1 |
| positive regulation of immunoglobulin production | 1 |
| immune response | 1 |
| signal transduction | 1 |
| immunoglobulin mediated immune response | 1 |
| positive regulation of chemokine production | 1 |
| interleukin-4-mediated signaling pathway | 1 |
| defense response to protozoan | 1 |
| positive regulation of macrophage activation | 1 |
| positive regulation of mast cell degranulation | 1 |
| T-helper 1 cell differentiation | 1 |
| T-helper 2 cell differentiation | 1 |
| negative regulation of T-helper 1 cell differentiation | 1 |
| positive regulation of T-helper 2 cell differentiation | 1 |
| positive regulation of cold-induced thermogenesis | 1 |
Indications & clinical
Indications
6 indications (0 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 |
|---|---|---|---|
| atopic eczema | 3 | MONDO:0004980 | EFO:0000274 |
| allergic rhinitis | 3 | MONDO:0011786 | EFO:0005854 |
| seasonal allergic rhinitis | 3 | MONDO:0005324 | EFO:0003956 |
| asthma | 2 | MONDO:0004979 | MONDO:0004979 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 34.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 12 |
| PHASE3 | 7 |
| Not specified | 6 |
| PHASE1 | 4 |
| PHASE2/PHASE3 | 2 |
| PHASE1/PHASE2 | 2 |
| PHASE4 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT06801353 | PHASE4 | NOT_YET_RECRUITING | A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps |
| NCT05761028 | PHASE2/PHASE3 | RECRUITING | A Study of CM310 in Subjects With Moderate to Severe Asthma |
| NCT06424470 | PHASE3 | ACTIVE_NOT_RECRUITING | Study on the Treatment of Prurigo Nodularis With Stapokibart Injection |
| NCT06495229 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of CM310 in Adolescent Subjects With Atopic Dermatis |
| NCT06547333 | PHASE2/PHASE3 | NOT_YET_RECRUITING | A Study of CM310 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease |
| NCT07210554 | PHASE3 | NOT_YET_RECRUITING | Study of Stapokibart Injection in Subjects With Moderate to Severe Bullous Pemphigoid |
| NCT05265923 | PHASE3 | COMPLETED | A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis |
| NCT05436275 | PHASE3 | COMPLETED | A Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyposis （CROWNS-2） |
| NCT05908032 | PHASE3 | COMPLETED | Study of CM310 in Subjects With Allergic Rhinitis |
| NCT06277765 | PHASE3 | COMPLETED | Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis |
| NCT06525597 | PHASE2 | RECRUITING | Study of Stapokibart Injection in Patients With Allergic Rhinitis |
| NCT04805398 | PHASE2 | COMPLETED | Subcutaneously CM310/Placebo in Patients With Chronic Rhinosinusitis With Nasal Polyposis (CROWNS-1) |
| NCT04805411 | PHASE2 | COMPLETED | Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD) |
| NCT04893707 | PHASE2 | COMPLETED | The Study of CM310 in Patients With Atopic Dermatitis |
| NCT04893941 | PHASE1/PHASE2 | COMPLETED | Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD) |
| NCT05131464 | PHASE2 | COMPLETED | The Study of CM310 in Patients With Chronic Rhinosinusitis With Nasal Polyps |
| NCT05186909 | PHASE2 | COMPLETED | A Study of CM310 in Subjects With Moderate to Severe Asthma |
| NCT05452343 | PHASE2 | UNKNOWN | A Study of CM310 in Subjects With Chronic Pruritus |
| NCT05579925 | PHASE2 | COMPLETED | A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis |
| NCT05715320 | PHASE2 | COMPLETED | Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis |
| NCT05908721 | PHASE2 | COMPLETED | Study of CM310 in Patients With Allergic Rhinitis |
| NCT06116565 | PHASE2 | UNKNOWN | A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis |
| NCT06162507 | PHASE1/PHASE2 | COMPLETED | Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis |
| NCT06171074 | PHASE2 | UNKNOWN | Study of CM310 in Subjects With Seasonal Allergic Rhinitis |
| NCT07040072 | PHASE1 | RECRUITING | Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic HNSCC |
| NCT05702450 | PHASE1 | COMPLETED | Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310 |
| NCT06161090 | PHASE1 | COMPLETED | Study of CM310 in Healthy Subjects |
| NCT06171048 | PHASE1 | UNKNOWN | Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects |
| NCT07143864 | Not specified | NOT_YET_RECRUITING | Efficacy and Safety of Stapokibart for Primary Cutaneous Amyloidosis |
| NCT07240376 | Not specified | NOT_YET_RECRUITING | Efficacy and Safety of Stapokibart in Non-Allergic Rhinitis With Eosinophilia Syndrome |
| NCT07459556 | Not specified | NOT_YET_RECRUITING | A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR) |
| NCT07483268 | Not specified | NOT_YET_RECRUITING | A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) . |
| NCT07544862 | Not specified | NOT_YET_RECRUITING | A Study of Stapokibart Injection in Patients With Atopic Dermatitis (AD) |
| NCT05728684 | Not specified | UNKNOWN | Study to Evaluate the Efficacy and Safety of CM310 in Subjects With IgG4-related Disease |
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: IL4R
- Diseases: atopic eczema, allergic rhinitis, seasonal allergic rhinitis