Dupixent

(Dupilumab)

ApprovedMonoclonal antibody

Dupilumab is used to treat moderate to severe eczema, asthma, and chronic rhinosinusitis by reducing inflammation and helping the immune system stop overreacting to allergens and irritants.[2] Dupixent is currently approved and in use across 59 indications[4].[1]

Dupixent is one of 815 monoclonal antibody programs targeting Insulin resistance. It is currently in Approved.

Indications

222

Total Trials

Active Trials

814

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

Chronic Rhinosinusitis Without Nasal PolypsActive, not recruiting

Nasal PolyposisUnknown

AllergyActive, not recruiting

Respiratory System DiseaseActive, not recruiting

Bullous PemphigoidUnknown

Peanut Allergic ReactionActive, not recruiting

Atopic EczemaUnknown

SinusitisUnknown

Allergic ConjunctivitisActive, not recruiting

Insulin ResistancePhase 1

Active, not recruiting

Chronic Rhinosinusitis Without Nasal PolypsPhase 2

Active, not recruiting

Nasal PolyposisPreclinical

Unknown

AllergyPhase 2

Active, not recruiting

Respiratory System DiseasePhase 2

Active, not recruiting

Bullous PemphigoidPreclinical

Unknown

Peanut Allergic ReactionPhase 2

Active, not recruiting

Atopic EczemaPreclinical

Unknown

SinusitisPreclinical

Unknown

Allergic ConjunctivitisPhase 2

Active, not recruiting

Showing 10 of 58 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Approved

1 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

DATROWAY

Daiichi Sankyo

Preclinical

4 4

Zolymbus

AbbVie

Preclinical

1 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Acupan

YYonsei University

Preclinical

1 7

Chantix

PPrism Pharmaceuticals

Preclinical

1 8

Avastin

Roche

Preclinical

4 9

Paracetamol

GSK

Preclinical

1 10

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Not yet recruiting

Biosimilarity

NCT07334496

Active, not recruiting

Chronic Rhinosinusitis

NCT06393946

Post-ApprovalActive, not recruiting

Allergic Contact Dermatitis

NCT03935971

Post-ApprovalActive, not recruiting

Atopic Dermatitis

NCT05983068

Post-ApprovalRecruiting

Asthma

NCT04743791

Post-ApprovalActive, not recruiting

Atopic Dermatitis

NCT05642208

Clinical

Trials by Indication[1]

Atopic Dermatitis58 trials

Replication of the Heads Up Atopic Dermatitis Trial With Registry Data

Recruiting·TTechnische Universität Dresden··NCT06937788·240 enrolled

An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis

Unknown status·EEric Simpson·Phase 4·NCT04520308·45 enrolled

Dupilumab in Japanese Patients With Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT04678882·62 enrolled

Show 55 more trials

Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

Active, not recruiting·NNantes University Hospital·Phase 4·NCT05642208·256 enrolled

Dupilumab Skin Barrier Function Study in Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 4·NCT04447417·52 enrolled

Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis (AD)

Active, not recruiting· Sanofi logo

Sanofi··NCT03992417·955 enrolled

Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 4·NCT04823130·54 enrolled

A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients

Completed· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 1·NCT06193434·99 enrolled

Dupilumab-PEdiatric Skin Barrier Function and LIpidomics STudy in Patients With Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 4·NCT04718870·41 enrolled

Evaluation of the Effectiveness and Safety of Immunosuppressive and Biological Therapy of Atopic Dermatitis in Childhood

Unknown status·NNational Medical Research Center for Children's Health, Russian Federation·Phase 4·NCT04895423·160 enrolled

Dupilumab De-escalation in Pediatric Atopic Dermatitis

Recruiting·JJohns Hopkins University·Phase 4·NCT06116526·30 enrolled

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

Recruiting· AbbVie logo

AbbVie·Phase 3·NCT06461897·675 enrolled

Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermatitis

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT03389893·72 enrolled

Open-label Study of Dupilumab in Patients With Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 3·NCT01949311·2,733 enrolled

A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

Completed· Regeneron logo

Regeneron·Phase 2·NCT02407756·78 enrolled

Treatment of Alopecia Areata (AA) With Dupilumab in Patients With and Without Atopic Dermatitis (AD)

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT03359356·60 enrolled

A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab

Active, not recruiting· Sanofi logo

Sanofi··NCT06169527·303 enrolled

Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 2·NCT01639040·31 enrolled

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT05601882·920 enrolled

Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Moderate-to-Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

Completed· Regeneron logo

Regeneron·Phase 2/3·NCT03346434·202 enrolled

Dupilumab and House Dust Mite Immunotherapy in Patients With Atopic Dermatitis

Completed·MMedical University of Silesia·N/A·NCT06509243·132 enrolled

Efficacy and Safety of REGN3500 Monotherapy and Combination of REGN3500 Plus Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Terminated· Regeneron logo

Regeneron·Phase 2·NCT03736967·206 enrolled

A Study to Assess the Efficacy and Safety of Dupilumab in Participants With Severe Atopic Dermatitis (AD) That Are Not Controlled With Oral Cyclosporine A (CSA) or for Those Who Cannot Take Oral CSA Because it is Not Medically Advisable

Completed· Regeneron logo

Regeneron·Phase 3·NCT02755649·325 enrolled

An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis

Active, not recruiting·AApogee Therapeutics, Inc.·Phase 1·NCT07027527·86 enrolled

Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT05436535·433 enrolled

Study of Dupilumab and Immune Responses in Adults With Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 2·NCT02210780·194 enrolled

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron··NCT05203380·45 enrolled

Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 3·NCT03345914·367 enrolled

Dupilumab Skin BArrier Function and LIpidomics STudy in Atopic Dermatitis in China

Completed· Sanofi logo

Sanofi·Phase 4·NCT05624112·44 enrolled

Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD)

Active, not recruiting· Regeneron logo

Regeneron··NCT03428646·858 enrolled

A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04791319·199 enrolled

Study to Determine the Safety and Effectiveness of Dupilumab for Treatment of Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 2·NCT01979016·54 enrolled

A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis

Recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT07330934·403 enrolled

Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China

Completed· Sanofi logo

Sanofi·Phase 4·NCT05680298·34 enrolled

Dupilmuab for Atopic Dermatitis Monitored With Noninvasive Imaging.

Unknown status·OOptiSkin Medical·Phase 4·NCT05265234·15 enrolled

Study to Assess the Efficacy and Long-term Safety of Dupilumab (REGN668/SAR231893) in Adult Participants With Moderate-to-Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 3·NCT02260986·740 enrolled

Safety and Tolerability of Dupilumab in Participants With Moderate to Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 1·NCT01385657·37 enrolled

Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 3·NCT02277743·671 enrolled

The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

Completed·UUniversity of California, San Francisco·Phase 4·NCT03667014·34 enrolled

The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis

Recruiting· Sanofi logo

Sanofi··NCT07467564·184 enrolled

A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD)

Completed· Regeneron logo

Regeneron·Phase 3·NCT02395133·422 enrolled

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Recruiting· Regeneron logo

Regeneron··NCT03936335·3,930 enrolled

Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab

Withdrawn· Regeneron logo

Regeneron·Phase 4·NCT07187089

Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 3·NCT02277769·708 enrolled

A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis

Recruiting· Innovent Biologics (Suzhou) Co. Ltd. logo

Innovent Biologics (Suzhou) Co. Ltd.·Phase 2·NCT07399067·120 enrolled

Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 1·NCT03050151·176 enrolled

A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis

Completed· AbbVie logo

AbbVie·Phase 3·NCT03738397·673 enrolled

Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

Completed·UUniversity of California, San Francisco·Phase 4·NCT03293030·17 enrolled

Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Completed· Sanofi logo

Sanofi·Phase 3·NCT03912259·165 enrolled

Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 2·NCT01859988·380 enrolled

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

Completed· Pfizer logo

Pfizer·Phase 3·NCT03720470·838 enrolled

Atopic Dermatitis Treated With Dupilumab and JAK Inhibitors in Costa Rica

Not yet recruiting·CCaja Costarricense de Seguro Social··NCT07448363·50 enrolled

Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

Active, not recruiting· Sanofi logo

Sanofi··NCT06415175·143 enrolled

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Completed· Regeneron logo

Regeneron·Phase 3·NCT03054428·251 enrolled

Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis

Completed· Regeneron logo

Regeneron··NCT04287608·50 enrolled

A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis

Active, not recruiting· Sanofi logo

Sanofi·Phase 4·NCT05983068·48 enrolled

Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

Active, not recruiting· Regeneron logo

Regeneron·Phase 3·NCT02612454·880 enrolled

Asthma30 trials

Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

Completed· Sanofi logo

Sanofi·Phase 3·NCT03782532·486 enrolled

Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT02573233·42 enrolled

Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma.

Completed·MMcMaster University·Phase 3·NCT03884842·24 enrolled

Show 27 more trials

A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma

Recruiting·UUniversité de Sherbrooke·Phase 3·NCT07309614·150 enrolled

Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)

Completed· Sanofi logo

Sanofi·Phase 3·NCT03560466·378 enrolled

Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

Completed· Sanofi logo

Sanofi·Phase 3·NCT03620747·393 enrolled

Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

Active, not recruiting· Sanofi logo

Sanofi··NCT04550962·376 enrolled

Dupilumab for Severe Asthma in a Real Life Setting

Completed·AAssistance Publique - Hôpitaux de Paris··NCT04022447·86 enrolled

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

Completed· Sanofi logo

Sanofi·Phase 3·NCT02528214·210 enrolled

Unknown status·—··NCT04665141·600 enrolled

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT05097287·1,324 enrolled

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06191315·90 enrolled

Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants

Completed· Sanofi logo

Sanofi·Phase 2·NCT03387852·296 enrolled

Study of REGN3500 and Dupilumab in Patients With Asthma

Completed· Regeneron logo

Regeneron·Phase 1·NCT03112577·32 enrolled

Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT01312961·104 enrolled

Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

Recruiting·SSally E. Wenzel MD·Phase 4·NCT04743791·30 enrolled

A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma

Completed· Regeneron logo

Regeneron·Phase 4·NCT04203797·40 enrolled

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Completed· Sanofi logo

Sanofi·Phase 2·NCT01854047·776 enrolled

Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02134028·2,282 enrolled

Investigating Dupilumab's Effect in Asthma by Genotype

Active, not recruiting·—·Phase 4·NCT03694158·150 enrolled

Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)

Completed· Sanofi logo

Sanofi·Phase 3·NCT02414854·1,902 enrolled

Viral Infection in Asthma (VIA) Study

Recruiting·UUniversity of Virginia·Phase 4·NCT04380038·60 enrolled

Evaluation of Dupilumab in Children With Uncontrolled Asthma

Completed· Sanofi logo

Sanofi·Phase 3·NCT02948959·408 enrolled

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

Recruiting· Regeneron logo

Regeneron·Phase 4·NCT06572228·250 enrolled

The Effectiveness and Safety of Dupilumab in Children with Asthma in China: a Real-world Study

Enrolling by invitation·GGuangzhou Institute of Respiratory Disease··NCT06851403·213 enrolled

Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05347771·240 enrolled

DETACT sEvere asThmAtiC paTients - a Pilot Study

Recruiting·MMedical University of Vienna··NCT07025200·10 enrolled

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Recruiting·UUniversity of California, San Diego·Phase 4·NCT06385236·120 enrolled

Effects of Interleukin (IL)- 4R-alpha Inhibition on Respiratory Microbiome and Immunologic Correlates in Severe Asthma

Completed·UUniversity of Michigan·Phase 4·NCT05036733·15 enrolled

The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

Completed· Sanofi logo

Sanofi·Phase 4·NCT04400318·109 enrolled

Eosinophilic Esophagitis9 trials

Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE)

Completed· Regeneron logo

Regeneron·Phase 2·NCT02379052·47 enrolled

Effect of Dupilumab on the Muscle Function of the Esophagus (food Pipe) in Participants with Eosinophilic Esophagitis (EoE)

Recruiting·UUniversity of California, San Diego·Phase 4·NCT06665971·30 enrolled

Comparison of Eohilia With Dupixent on Esophagus Diameter in Patients With Eosinophilic Esophagitis.

Not yet recruiting·MMayo Clinic·Phase 1·NCT07358234·60 enrolled

Show 6 more trials

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)

Active, not recruiting· Sanofi logo

Sanofi·Phase 4·NCT06101095·69 enrolled

A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany

Recruiting· Sanofi logo

Sanofi··NCT06695897·150 enrolled

A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care

Recruiting· Regeneron logo

Regeneron··NCT06693531·350 enrolled

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Completed· Regeneron logo

Regeneron·Phase 3·NCT03633617·321 enrolled

Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis

Completed·—·Phase 4·NCT05247866·21 enrolled

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

Completed· Regeneron logo

Regeneron·Phase 3·NCT04394351·102 enrolled

Prurigo Nodularis6 trials

A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine

Recruiting· Sanofi logo

Sanofi··NCT06087627·150 enrolled

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04202679·160 enrolled

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04183335·151 enrolled

Show 3 more trials

Early and Long-Term Efficacy and Immune Changes With Dupilumab in Prurigo Nodularis

Recruiting·UUMC Utrecht··NCT07276425·40 enrolled

Real-World Effectiveness of Dupilumab in Patients With Prurigo Nodularis: An Observational Study

Active, not recruiting· Sanofi logo

Sanofi··NCT05991323·100 enrolled

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06293053·18 enrolled

Chronic Rhinosinusitis5 trials

Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)

Completed· Sanofi logo

Sanofi·Phase 4·NCT05049122·25 enrolled

Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

Active, not recruiting· Sanofi logo

Sanofi··NCT06393946·150 enrolled

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Recruiting·MMontefiore Medical Center··NCT05246267·60 enrolled

Show 2 more trials

Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Recruiting·UUniversitaire Ziekenhuizen KU Leuven··NCT06683261·300 enrolled

Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps

Not yet recruiting·—·Phase 4·NCT06556264·60 enrolled

62 more indications

Chronic Spontaneous Urticaria4 trials

Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04180488·397 enrolled

A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria

Recruiting· Sanofi logo

Sanofi··NCT07316114·400 enrolled

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Completed· Sanofi logo

Sanofi·Phase 3·NCT05526521·15 enrolled

Show 1 more trial

Dupilumab in Chronic Spontaneous Urticaria

Completed·—·Phase 2·NCT03749135·72 enrolled

Allergy3 trials

Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy

Terminated·AAndrew J Long, PharmD·Phase 2·NCT04148352·33 enrolled

Study to Evaluate Dupilumab Monotherapy in Pediatric Patients With Peanut Allergy

Completed· Regeneron logo

Regeneron·Phase 2·NCT03793608·25 enrolled

Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)

Completed· Regeneron logo

Regeneron·Phase 2·NCT03682770·148 enrolled

CRSwNP3 trials

Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.

Recruiting·NNorthwestern University··NCT06892704·30 enrolled

Dupilumab in Chinese Adult Participants With CRSwNP

Completed· Sanofi logo

Sanofi·Phase 3·NCT05878093·63 enrolled

Early-onset Dupilumab Effects in CRSwNP

Withdrawn·UUniversity of Rochester·Phase 4·NCT06188871

Nasal polyposis3 trials

Dupilumab Severe Eosinophilic Chronic Sinusitis Without Nasal Polyposis

Active, not recruiting·UUniversity of South Florida·Phase 2·NCT04430179·30 enrolled

Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

Recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT04869436·27 enrolled

An Evaluation of Dupilumab in Patients With Nasal Polyposis And Chronic Symptoms Of Sinusitis

Completed· Sanofi logo

Sanofi·Phase 2·NCT01920893·60 enrolled

Bullous Pemphigoid3 trials

Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid

Completed·PPeking University First Hospital··NCT05649579·146 enrolled

Compassionate Use of Dupilumab for Adult Patients With Bullous Pemphigoid

Approved for marketing· Regeneron logo

Regeneron··NCT05906706

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

Completed· Regeneron logo

Regeneron·Phase 2/3·NCT04206553·106 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

Completed·UUniversity Hospital, Toulouse·Phase 2·NCT03861455·94 enrolled

Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD Patients

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT06465732·220 enrolled

Nasal Polyps2 trials

Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps

Completed· Sanofi logo

Sanofi·Phase 3·NCT02898454·448 enrolled

A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps

Completed· Sanofi logo

Sanofi·Phase 3·NCT02912468·276 enrolled

Inflammation2 trials

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation

Completed· Sanofi logo

Sanofi·Phase 3·NCT03930732·939 enrolled

Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau··NCT05787678·30 enrolled

Sinusitis2 trials

Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04684524·62 enrolled

Study of Dupilumab 300 mg Every Other Week After Endoscopic Sinus Surgery in Patients With Allergic Fungal Rhinosinusitis (AFRS) on a Background Therapy With Intranasal Corticosteroid Spray

Withdrawn·NNational Institute on Deafness and Other Communication Disorders (NIDCD)·Phase 3·NCT06461949

Tics2 trials

A Study to Investigate the Pharmacokinetics, Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants

Completed· Sanofi logo

Sanofi·Phase 1·NCT05976360·38 enrolled

A Study to Investigate the Pharmacokinetics (PK), Tolerability and Safety of Two Different Dupilumab Drug Products in Healthy Participants.

Completed· Sanofi logo

Sanofi·Phase 1·NCT05976373·38 enrolled

Treatment2 trials

The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

Completed·—·Phase 4·NCT04358224·12 enrolled

Dupilumab in the Treatment of Severe Uncontrolled CRSwNP: a Multicentre Observational Real-life Study (DUPIREAL)

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT05529784·600 enrolled

Atopic Eczema2 trials

DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema

Recruiting·—·Phase 4·NCT06004986·216 enrolled

Mind and Skin - the Neurocutaneous Axis in Atopic Eczema

Recruiting·KKing's College London··NCT05790330·90 enrolled

Chronic Obstructive Pulmonary Disease2 trials

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

Recruiting· Sanofi logo

Sanofi·Phase 4·NCT07053423·218 enrolled

Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Under Real-world Conditions

Recruiting· Sanofi logo

Sanofi··NCT07052396·350 enrolled

Keloid2 trials

Dupilumab in the Treatment of Keloids

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT04988022·44 enrolled

Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

Completed·—·Phase 2·NCT05128383·20 enrolled

Respiratory Disease2 trials

Mechanisms of Benefit of IL4RA Inhibition in Aspirin-Exacerbated Respiratory Disease

Active, not recruiting·—·Phase 2·NCT05575037·17 enrolled

Dupilumab for Aspirin-exacerbated Respiratory Disease

Completed·RRochester General Hospital·Phase 2·NCT03595488·11 enrolled

MPA2 trials

Compassionate Use of Dupilumab

Approved for marketing· Regeneron logo

Regeneron··NCT04776694

Dupilumab Compassionate Use Study

Approved for marketing·SSally E. Wenzel MD··NCT03020810

Eosinophilic Gastritis1 trial

Dupilumab in Eosinophilic Gastritis

Completed·—·Phase 2·NCT03678545·41 enrolled

Netherton syndrome1 trial

A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome

Unknown status·UUniversity Hospital, Toulouse·Phase 2/3·NCT04244006·24 enrolled

Colonization1 trial

Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP

Recruiting·UUniversity of Virginia·Phase 4·NCT05094570·20 enrolled

Pruritus1 trial

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Completed·MMayo Clinic·Phase 2·NCT04256759·9 enrolled

Cold Urticaria1 trial

Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04681729·82 enrolled

Single Dose1 trial

Single Dose Comparability Study of New and Current Dupilumab Drug Products Subcutaneously Administered in Healthy Adults

Completed· Sanofi logo

Sanofi·Phase 1·NCT05976386·182 enrolled

Scleroderma1 trial

Clinical Trial to Evaluate Efficacy and Safety of Dupilumab in Localized Scleroderma

Completed·UUniversity of Cologne·Phase 2·NCT04200755·45 enrolled

Moderate to Severe COPD1 trial

Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

Completed· Sanofi logo

Sanofi·Phase 3·NCT04456673·935 enrolled

Prevention1 trial

Dupilumab for Prevention of Recurrence of CRSwNP After ESS

Completed·—·Phase 4·NCT04596189·30 enrolled

Ichthyosis1 trial

Scientific Substantiation and Assessment of the Effectiveness of Pathogenetic Methods of Therapy for Congenital Ichthyosis in Children

Unknown status·NNational Medical Research Center for Children's Health, Russian Federation·Phase 4·NCT04996485·50 enrolled

Function1 trial

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

Recruiting·MMedical University of Vienna··NCT06398873·80 enrolled

Biosimilarity1 trial

A Study to Evaluate the Biosimilarity of GLR1044 Injection and Dupilumab Injection (Dupixent®) in Healthy Adult Male Subjects

Not yet recruiting·GGan & Lee Pharmaceuticals.·Phase 1·NCT07334496·198 enrolled

Tolerance1 trial

Effect of Dupilumab on Aspirin Intolerance

Unknown status·MMedical University of Vienna·Phase 4·NCT04442256·30 enrolled

Sleep1 trial

SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Completed· Sanofi logo

Sanofi·Phase 4·NCT04033367·188 enrolled

Chronic Rhinosinusitis Without Nasal Polyps1 trial

Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Completed·JJohns Hopkins University·Phase 2·NCT04362501·33 enrolled

Non-Small Cell Lung Cancer1 trial

Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer

Not yet recruiting·—·N/A·NCT06743581·24 enrolled

Urticaria1 trial

Cholinergic Urticaria - Efficacy of Dupilumab

Completed·—·Phase 2·NCT03749148·48 enrolled

COVID-191 trial

Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients

Completed·UUniversity of Virginia·Phase 2·NCT04920916·40 enrolled

Skin Disease1 trial

Molecular Signatures in Inflammatory Skin Disease

Recruiting·PProf. Dr. Stephan Weidinger··NCT03358693·300 enrolled

Insulin resistance1 trial

IL-4 and Insulin Resistance for Treatment of Patients With Atopic Dermatitis

Completed·MMayo Clinic·Phase 1·NCT05372003·7 enrolled

Chronic Rhinosinusitis With Nasal Polyps1 trial

A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps

Active, not recruiting·RRigshospitalet, Denmark·Phase 4·NCT05942222·220 enrolled

Sleep Apnea1 trial

Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

Terminated·—·Phase 1·NCT03675022·9 enrolled

Nephrotic Syndrome1 trial

Dupilumab Therapy in Nephrotic Syndrome in Children

Recruiting·NNational University Hospital, Singapore·Phase 2·NCT07091175·66 enrolled

Skin1 trial

Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders

Recruiting·NNorthwestern University·Phase 1·NCT05649098·30 enrolled

Dermatitis1 trial

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)

Completed· Regeneron logo

Regeneron·Phase 3·NCT04417894·133 enrolled

Allergic Bronchopulmonary Aspergillosis1 trial

Investigating Treatment With Dupilumab in Patients With Allergic Bronchopulmonary Aspergillosis (ABPA) (LIBERTY ABPA AIRED)

Completed· Regeneron logo

Regeneron·Phase 2·NCT04442269·62 enrolled

Pregnancy1 trial

Post-authorization Safety Study in North America to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy

Completed· Regeneron logo

Regeneron··NCT04173442·581 enrolled

AIN1 trial

Dupilumab Effects Against Aeroallergen Challenge

Recruiting·TThe University of Texas Health Science Center at San Antonio·Phase 2·NCT05720325·88 enrolled

Liver Metastases1 trial

Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases

Not yet recruiting·DDan Feng·Phase 1/2·NCT07277322·24 enrolled

Metastatic NSCLC1 trial

Dupilumab_Metastatic NSCLC

Active, not recruiting·TThomas Marron·Phase 1/2·NCT05013450·33 enrolled

Allergic Contact Dermatitis1 trial

The Effects of Dupilumab on Allergic Contact Dermatitis

Active, not recruiting·—·Phase 4·NCT03935971·17 enrolled

Resectable NSCLC1 trial

Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT06088771·21 enrolled

Alopecia Areata1 trial

Dupilumab in the Treatment of Pediatric Alopecia Areata

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT05866562·76 enrolled

Adolescent1 trial

Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial

Completed· Regeneron logo

Regeneron·Phase 4·NCT05590585·124 enrolled

Breast Cancer1 trial

Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer

Recruiting·RRima Patel·Phase 1·NCT06637306·15 enrolled

Chronic Hand Eczema1 trial

Dupilumab in Severe Chronic Hand Eczema

Unknown status·UUniversity Medical Center Groningen·Phase 2·NCT04512339·30 enrolled

Keratoconjunctivitis1 trial

Evaluation of Dupilumab in Patients With Atopic Keratoconjunctivitis (AKC)

Unknown status·AAndover Eye Associates·Phase 2·NCT04296864·42 enrolled

Effectiveness1 trial

Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT06705387·72 enrolled

MPR1 trial

Mechanisms of Smell Improvement With Dupilumab.

Completed·MMedical University of South Carolina·Phase 4·NCT05964465·60 enrolled

Contact Dermatitis1 trial

Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation

Recruiting·WWei-Che Ko·Phase 2/3·NCT05535738·45 enrolled

Hypersensitivity1 trial

The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction

Completed·UUniversity of Michigan·Phase 4·NCT06012448·10 enrolled

Completed· Sanofi logo

Sanofi·Phase 4·NCT04998604·360 enrolled

Unspecified9 trials

Molecular Signatures of Cutaneous Dupilumab Response

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT05858619·15 enrolled

Dupilumab Therapy for EGIDs

Recruiting·—··NCT07257835·20 enrolled

Dupilumab in CRSsNP

Completed· Sanofi logo

Sanofi·Phase 3·NCT04678856·71 enrolled

Show 6 more trials

Real Life Experience Survey of Dupilumab in the Netherlands

Completed·GGert-Jan Braunstahl··NCT05331755·120 enrolled

Dupilumab Phase 4 Study

Terminated·NNorthwestern University··NCT03411837·46 enrolled

Regeneron AA Multicenter (Dupilumab)

Recruiting·EEmma Guttman·Phase 2·NCT05551793·68 enrolled

Dupixent Study for Alternate Administration

Active, not recruiting·MMadigan Army Medical Center·Phase 4·NCT06750471·30 enrolled

Ethnic Differences in Mechanisms of Action of Dupilumab

Recruiting·UUniversity of Michigan·Phase 4·NCT05268107·30 enrolled

Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)

Terminated·EEmory University·Phase 3·NCT05545072·5 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 28, 2017

Dupixent

BLA 761055

Mar 28, 2017

DUPIXENT

BLA BLA761055

Sources

References

[1]
ClinicalTrials.gov — 222 trial records for Dupilumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dupixent drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dupilumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dupilumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA 761055). U.S. Food & Drug Administration.
[6]
PubMed — 3 publications indexed for Dupilumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Azienda U.S.L. 1 di Massa e Carrara company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: IL-4/IL-13 Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: AAzienda U.S.L. 1 di Massa e Carrara

Key Publications[6]

Dupilumab in Adolescents with Moderate-to-Severe Asthma: VOYAGE Trial

Lancet Respir MedApr 20, 2023DOI: 10.1016/S2213-2600(23)00098-7

Dupilumab in Uncontrolled COPD with Type 2 Inflammation: BOREAS Trial

N Engl J MedOct 6, 2022DOI: 10.1056/NEJMoa2209184

Long-Term Safety and Efficacy of Dupilumab in Atopic Dermatitis

JAMA DermatolAug 17, 2022DOI: 10.1001/jamadermatol.2022.3312

Dupixent

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Atopic Dermatitis58 trials

Asthma30 trials

Eosinophilic Esophagitis9 trials

Prurigo Nodularis6 trials

Chronic Rhinosinusitis5 trials

Chronic Spontaneous Urticaria4 trials

Allergy3 trials

CRSwNP3 trials

Nasal polyposis3 trials

Bullous Pemphigoid3 trials

Efficacy and Safety2 trials

Nasal Polyps2 trials

Inflammation2 trials

Sinusitis2 trials

Tics2 trials

Treatment2 trials

Atopic Eczema2 trials

Chronic Obstructive Pulmonary Disease2 trials

Keloid2 trials

Respiratory Disease2 trials

MPA2 trials

Eosinophilic Gastritis1 trial

Netherton syndrome1 trial

Colonization1 trial

Pruritus1 trial

Cold Urticaria1 trial

Single Dose1 trial

Scleroderma1 trial

Moderate to Severe COPD1 trial

Prevention1 trial

Ichthyosis1 trial

Function1 trial

Biosimilarity1 trial

Tolerance1 trial

Sleep1 trial

Chronic Rhinosinusitis Without Nasal Polyps1 trial

Non-Small Cell Lung Cancer1 trial

Urticaria1 trial

COVID-191 trial

Skin Disease1 trial

Insulin resistance1 trial

Chronic Rhinosinusitis With Nasal Polyps1 trial

Sleep Apnea1 trial

Nephrotic Syndrome1 trial

Skin1 trial

Dermatitis1 trial

Allergic Bronchopulmonary Aspergillosis1 trial

Pregnancy1 trial

AIN1 trial

Liver Metastases1 trial

Metastatic NSCLC1 trial

Allergic Contact Dermatitis1 trial

Resectable NSCLC1 trial

Alopecia Areata1 trial

Adolescent1 trial

Breast Cancer1 trial

Chronic Hand Eczema1 trial

Keratoconjunctivitis1 trial

Effectiveness1 trial

MPR1 trial

Contact Dermatitis1 trial

Hypersensitivity1 trial

Memory1 trial

Hypereosinophilic syndrome1 trial

Prostate Cancer1 trial

Omalizumab1 trial

Unspecified9 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News