Dupilumab
drugOn this page
Also known as DupixentREGN-668REGN668sar231893SAR-231893
Summary
Dupilumab (CHEMBL2108675) is an approved antibody (ATC D11AH05) targeting IL4R; indicated across 35 conditions including atopic eczema and nasal cavity polyp.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: D11AH05
- Targets: 1 (IL4R)
- Indications: 35 conditions
- Clinical trials: 218
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL2108675 |
| Name | Dupilumab |
| Type | Antibody |
| Max phase | 4 |
| ATC | D11AH05 |
Also known as: Dupilumab, Dupixent, REGN-668, REGN668, Regn668, sar231893, SAR-231893, SAR231893, DUPILUMAB
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 | Binding | 11.06 | 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
35 indications (8 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 | 4 | MONDO:0004980 | EFO:0000274 |
| nasal cavity polyp | 4 | MONDO:0006314 | EFO:1000391 |
| sinusitis | 4 | MONDO:0005961 | EFO:0007486 |
| asthma | 4 | MONDO:0004979 | MONDO:0004979 |
| esophageal disorder | 4 | MONDO:0003749 | EFO:0009544 |
| prurigo | 4 | MONDO:0021739 | MONDO:0021739 |
| eosinophilic esophagitis | 3 | MONDO:0005361 | EFO:0004232 |
| chronic obstructive pulmonary disease | 3 | MONDO:0005002 | EFO:0000341 |
| neurodermatitis | 3 | MONDO:0006585 | EFO:1000740 |
| dermatitis | 3 | MONDO:0002406 | MONDO:0002406 |
| cold urticaria | 3 | MONDO:0022799 | EFO:1001881 |
| alopecia areata | 2 | MONDO:0005340 | EFO:0004192 |
| respiratory system disorder | 2 | MONDO:0005087 | EFO:0000684 |
| urticaria | 2 | MONDO:0005492 | EFO:0005531 |
| allergic rhinitis | 2 | MONDO:0011786 | EFO:0005854 |
| angioedema | 2 | MONDO:0010481 | EFO:0005532 |
| atopic conjunctivitis | 2 | MONDO:0005642 | EFO:0007141 |
| bullous pemphigoid | 2 | MONDO:0019082 | EFO:0007187 |
| localized scleroderma | 2 | MONDO:0019562 | EFO:1001361 |
| allergic bronchopulmonary aspergillosis | 2 | MONDO:0015243 | EFO:0007140 |
| severe acute respiratory syndrome | 2 | MONDO:0005091 | MONDO:0100096 |
| keloid | 2 | MONDO:0005348 | EFO:0004212 |
| Netherton syndrome | 2 | MONDO:0009735 | MONDO:0009735 |
| ulcerative colitis | 2 | MONDO:0005101 | EFO:0000729 |
| hypereosinophilic syndrome | 2 | MONDO:0015691 | EFO:1001467 |
| allergic disease | 2 | MONDO:0005271 | MONDO:0005271 |
| non-small cell lung carcinoma | 1 | MONDO:0005233 | EFO:0003060 |
| food allergy | 1 | MONDO:0700226 | EFO:1001890 |
| skin disorder | 0 | MONDO:0005093 | EFO:0000701 |
6 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 218.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 52 |
| PHASE3 | 48 |
| PHASE2 | 48 |
| Not specified | 45 |
| PHASE1 | 14 |
| EARLY_PHASE1 | 5 |
| PHASE2/PHASE3 | 3 |
| PHASE1/PHASE2 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT03694158 | PHASE4 | ACTIVE_NOT_RECRUITING | Investigating Dupilumab’s Effect in Asthma by Genotype |
| NCT03935971 | PHASE4 | ACTIVE_NOT_RECRUITING | The Effects of Dupilumab on Allergic Contact Dermatitis |
| NCT04743791 | PHASE4 | RECRUITING | Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma |
| NCT04869436 | PHASE4 | RECRUITING | Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis |
| NCT05042258 | PHASE4 | RECRUITING | Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis |
| NCT05097287 | PHASE4 | ACTIVE_NOT_RECRUITING | Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma |
| NCT05268107 | PHASE4 | RECRUITING | Ethnic Differences in Mechanisms of Action of Dupilumab |
| NCT05285839 | PHASE4 | RECRUITING | Dupixent and Narrowband UVB for Atopic Dermatitis |
| NCT05642208 | PHASE4 | ACTIVE_NOT_RECRUITING | Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis |
| NCT05858619 | PHASE4 | RECRUITING | Molecular Signatures of Cutaneous Dupilumab Response |
| NCT05942222 | PHASE4 | ACTIVE_NOT_RECRUITING | A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps |
| NCT05983068 | PHASE4 | ACTIVE_NOT_RECRUITING | A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis |
| NCT06004986 | PHASE4 | RECRUITING | DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema |
| NCT06101095 | PHASE4 | ACTIVE_NOT_RECRUITING | A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial) |
| NCT06352073 | PHASE4 | ACTIVE_NOT_RECRUITING | Dupilumab for Eosinophilic Esophagitis With Severe Strictures |
| NCT06385236 | PHASE4 | RECRUITING | Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping |
| NCT06465732 | PHASE4 | NOT_YET_RECRUITING | Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients |
| NCT06556264 | PHASE4 | NOT_YET_RECRUITING | Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps |
| NCT06572228 | PHASE4 | ACTIVE_NOT_RECRUITING | Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma |
| NCT06665971 | PHASE4 | RECRUITING | Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE) |
| NCT06750471 | PHASE4 | ACTIVE_NOT_RECRUITING | Dupixent Study for Alternate Administration |
| NCT06818019 | PHASE4 | NOT_YET_RECRUITING | Withdrawal of Dupilumab in Severe Asthma |
| NCT07053423 | PHASE4 | RECRUITING | A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. |
| NCT07352566 | PHASE4 | NOT_YET_RECRUITING | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT07587658 | PHASE4 | NOT_YET_RECRUITING | This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization |
| NCT03293030 | PHASE4 | COMPLETED | Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis |
| NCT03389893 | PHASE4 | TERMINATED | Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis |
| NCT03667014 | PHASE4 | COMPLETED | The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients |
| NCT04033367 | PHASE4 | COMPLETED | SAR231893-LPS15497- Dupilumab Effect on Sleep in AD Patients |
| NCT04203797 | PHASE4 | COMPLETED | A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma |
| NCT04400318 | PHASE4 | COMPLETED | The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma |
| NCT04442256 | PHASE4 | UNKNOWN | Effect of Dupilumab on Aspirin Intolerance |
| NCT04447417 | PHASE4 | COMPLETED | Dupilumab Skin Barrier Function Study in Atopic Dermatitis |
| NCT04502862 | PHASE4 | COMPLETED | A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma |
| NCT04718870 | PHASE4 | COMPLETED | Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis |
| NCT04823130 | PHASE4 | COMPLETED | Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis |
| NCT04895423 | PHASE4 | UNKNOWN | Evaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood |
| NCT04988022 | PHASE4 | COMPLETED | Dupilumab in the Treatment of Keloids |
| NCT04996485 | PHASE4 | UNKNOWN | Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children |
| NCT04998604 | PHASE4 | COMPLETED | EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients |
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).