Dupilumab

drug
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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

FieldValue
ChEMBL IDCHEMBL2108675
NameDupilumab
TypeAntibody
Max phase4
ATCD11AH05

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).

GeneTargetActionpAffinityCancer dependencyUniProt
IL4RInterleukin-4 receptor subunit αBinding11.060.4%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:

PathwayTargetsGenes
Interleukin-4 and Interleukin-13 signaling1IL4R
Differentiation of naive CD4+ T cells to T helper 2 cells (Th2 cells)1IL4R

Dominant GO biological processes

GO termTargets
production of molecular mediator involved in inflammatory response1
positive regulation of immunoglobulin production1
immune response1
signal transduction1
immunoglobulin mediated immune response1
positive regulation of chemokine production1
interleukin-4-mediated signaling pathway1
defense response to protozoan1
positive regulation of macrophage activation1
positive regulation of mast cell degranulation1
T-helper 1 cell differentiation1
T-helper 2 cell differentiation1
negative regulation of T-helper 1 cell differentiation1
positive regulation of T-helper 2 cell differentiation1
positive regulation of cold-induced thermogenesis1

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).

IndicationTrial phaseMONDOEFO
atopic eczema4MONDO:0004980EFO:0000274
nasal cavity polyp4MONDO:0006314EFO:1000391
sinusitis4MONDO:0005961EFO:0007486
asthma4MONDO:0004979MONDO:0004979
esophageal disorder4MONDO:0003749EFO:0009544
prurigo4MONDO:0021739MONDO:0021739
eosinophilic esophagitis3MONDO:0005361EFO:0004232
chronic obstructive pulmonary disease3MONDO:0005002EFO:0000341
neurodermatitis3MONDO:0006585EFO:1000740
dermatitis3MONDO:0002406MONDO:0002406
cold urticaria3MONDO:0022799EFO:1001881
alopecia areata2MONDO:0005340EFO:0004192
respiratory system disorder2MONDO:0005087EFO:0000684
urticaria2MONDO:0005492EFO:0005531
allergic rhinitis2MONDO:0011786EFO:0005854
angioedema2MONDO:0010481EFO:0005532
atopic conjunctivitis2MONDO:0005642EFO:0007141
bullous pemphigoid2MONDO:0019082EFO:0007187
localized scleroderma2MONDO:0019562EFO:1001361
allergic bronchopulmonary aspergillosis2MONDO:0015243EFO:0007140
severe acute respiratory syndrome2MONDO:0005091MONDO:0100096
keloid2MONDO:0005348EFO:0004212
Netherton syndrome2MONDO:0009735MONDO:0009735
ulcerative colitis2MONDO:0005101EFO:0000729
hypereosinophilic syndrome2MONDO:0015691EFO:1001467
allergic disease2MONDO:0005271MONDO:0005271
non-small cell lung carcinoma1MONDO:0005233EFO:0003060
food allergy1MONDO:0700226EFO:1001890
skin disorder0MONDO:0005093EFO: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

PhaseTrials
PHASE452
PHASE348
PHASE248
Not specified45
PHASE114
EARLY_PHASE15
PHASE2/PHASE33
PHASE1/PHASE23

Top trials by phase / activity

NCTPhaseStatusTitle
NCT03694158PHASE4ACTIVE_NOT_RECRUITINGInvestigating Dupilumab’s Effect in Asthma by Genotype
NCT03935971PHASE4ACTIVE_NOT_RECRUITINGThe Effects of Dupilumab on Allergic Contact Dermatitis
NCT04743791PHASE4RECRUITINGMeasuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
NCT04869436PHASE4RECRUITINGOlfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
NCT05042258PHASE4RECRUITINGUsing Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
NCT05097287PHASE4ACTIVE_NOT_RECRUITINGStudy Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
NCT05268107PHASE4RECRUITINGEthnic Differences in Mechanisms of Action of Dupilumab
NCT05285839PHASE4RECRUITINGDupixent and Narrowband UVB for Atopic Dermatitis
NCT05642208PHASE4ACTIVE_NOT_RECRUITINGDupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis
NCT05858619PHASE4RECRUITINGMolecular Signatures of Cutaneous Dupilumab Response
NCT05942222PHASE4ACTIVE_NOT_RECRUITINGA Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT05983068PHASE4ACTIVE_NOT_RECRUITINGA Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis
NCT06004986PHASE4RECRUITINGDUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema
NCT06101095PHASE4ACTIVE_NOT_RECRUITINGA 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)
NCT06352073PHASE4ACTIVE_NOT_RECRUITINGDupilumab for Eosinophilic Esophagitis With Severe Strictures
NCT06385236PHASE4RECRUITINGLeveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
NCT06465732PHASE4NOT_YET_RECRUITINGEfficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients
NCT06556264PHASE4NOT_YET_RECRUITINGImmunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps
NCT06572228PHASE4ACTIVE_NOT_RECRUITINGEfficacy 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
NCT06665971PHASE4RECRUITINGEffect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)
NCT06750471PHASE4ACTIVE_NOT_RECRUITINGDupixent Study for Alternate Administration
NCT06818019PHASE4NOT_YET_RECRUITINGWithdrawal of Dupilumab in Severe Asthma
NCT07053423PHASE4RECRUITINGA Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
NCT07352566PHASE4NOT_YET_RECRUITINGUtilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT07587658PHASE4NOT_YET_RECRUITINGThis 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
NCT03293030PHASE4COMPLETEDImmunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis
NCT03389893PHASE4TERMINATEDEffect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis
NCT03667014PHASE4COMPLETEDThe Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
NCT04033367PHASE4COMPLETEDSAR231893-LPS15497- Dupilumab Effect on Sleep in AD Patients
NCT04203797PHASE4COMPLETEDA Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
NCT04400318PHASE4COMPLETEDThe Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
NCT04442256PHASE4UNKNOWNEffect of Dupilumab on Aspirin Intolerance
NCT04447417PHASE4COMPLETEDDupilumab Skin Barrier Function Study in Atopic Dermatitis
NCT04502862PHASE4COMPLETEDA 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
NCT04718870PHASE4COMPLETEDDupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis
NCT04823130PHASE4COMPLETEDDupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis
NCT04895423PHASE4UNKNOWNEvaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood
NCT04988022PHASE4COMPLETEDDupilumab in the Treatment of Keloids
NCT04996485PHASE4UNKNOWNScientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children
NCT04998604PHASE4COMPLETEDEValuating 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.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).