Data updated: May 26, 2026
DUPIXENT (dupilumab)
Interleukin 4 Receptor alpha Antagonists Genetically Validated
Trial Activity: Stable 52 active trials
First-in-Class Breakthrough Therapy Priority Review
Immunology
Approved 2017-03-28
DUPIXENT is indicated for the treatment of Atopic Dermatitis; Asthma; Chronic Rhinosinusitis; Eosinophilic Esophagitis; Prurigo Nodularis.
How DUPIXENT Works
Dupilumab is a human monoclonal antibody that binds specifically to the IL-4Rα subunit, which is shared by the interleukin-4 (IL-4) and interleukin-13 (IL-13) receptor complexes. By blocking this subunit, the drug inhibits the signaling of IL-4 and IL-13, two cytokines that play a central role in the pathogenesis of various inflammatory diseases. This inhibition prevents the release of proinflammatory mediators, including cytokines, chemokines, nitric oxide, and IgE, from multiple cell types such as mast cells and eosinophils. Reducing these inflammatory responses helps manage the underlying biological drivers of the conditions for which the drug is approved.
Development Insights
Regeneron Pharmaceuticals conducting 37 trials (28%)
89 indications explored (Broad Platform)
→ atopic dermatitis (36 trials)
→ asthma (19 trials)
→ dermatitis, atopic (8 trials)
20
Indications
--
Phase 3 Trials
12
Priority Reviews
9
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-03-28
- Patent Cliff
- 2031
- Revenue
- $4.7B (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DUPIXENT Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
32 FDA actions from 2017 to 2026 · 19 indication expansions
What DUPIXENT Treats
5 indicationsDUPIXENT is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
- Asthma
- Chronic Rhinosinusitis
- Eosinophilic Esophagitis
- Prurigo Nodularis
Source: FDA Label
DUPIXENT Target & Pathway
ProTarget
A cytokine that promotes Th2 immune responses and IgE production. IL-4 drives allergic inflammation in atopic dermatitis and asthma. Blocking IL-4 (often together with IL-13) reduces the type 2 inflammation underlying these conditions.
DUPIXENT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
10
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What's emerging in DUPIXENT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DUPIXENT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DUPIXENT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
125 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06477653 | 10001979 001979-I | Ph 2 | recruiting | Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents |
| NCT06369467 | R5458-668-ALG-2219 2024-511032-27-00 | Ph 1 | recruiting | Short-Term Linvoseltamab Treatment on Top of Chronic Dupilumab Treatment for Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy |
| NCT07277322 | STUDY-25-01112 PRMC-25-088 IIT | Ph 1, Ph 2 | not yet recruiting | Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases |
| NCT06352073 DESTRICT | 23-2625 R668-EE-2380 | Ph 4 | active not recruiting | Dupilumab for Eosinophilic Esophagitis With Severe Strictures |
| NCT05042258 | 2021-4161 | Ph 4 | recruiting | Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis |
| NCT07053423 AEOLUS | LPS18583 2025-521268-37, U1111-1314-5262 | Ph 4 | recruiting | A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. |
| NCT06572228 AIM4:Next Step | R668-AS-2373 2023-510458-18-00 | Ph 4 | 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 |
| NCT05097287 ATLAS | LPS16676 U1111-1266-2849, 2024-513423-16 | Ph 4 | 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 |
| NCT05983068 PELISTAD-EX2 | LPS17764 U1111-1280-5813 | Ph 4 | active not recruiting | A Study of Long-term Effect of Dupilumab on Skin Barrier Function in Pediatric Participants With Atopic Dermatitis |
| NCT05263206 | EFC16973 U1111-1253-9888, 2023-508879-36-00 | Ph 3 | recruiting | Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) |
| NCT07112378 | R668-EE-2423 | Ph 3 | recruiting | A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis |
| NCT06461897 Start Up | M17-380 2023-504713-76-00 | Ph 3 | recruiting | 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 |
| NCT07027527 | APG279-101 | Ph 1 | active not recruiting | An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis |
| NCT06191315 | EFC14771 2023-504331-41, U1111-1246-7432 | Ph 3 | recruiting | Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS) |
| NCT06881251 DUPLEX-AD | 95475939ADM2001 95475939ADM2001, 2024-517814-13-00 | Ph 2 | active not recruiting | A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD) |
| NCT06868212 RECLAIM | CLOU064AUS02 | Ph 3 | recruiting | A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines |
| NCT07330934 | CIBI356A201 | Ph 2 | recruiting | A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis |
| NCT05720325 | HSC20220665H 1U01AI158460-01A1 | Ph 2 | recruiting | Dupilumab Effects Against Aeroallergen Challenge |
| NCT04206553 LIBERTY-BP results posted | R668-BP-1902 2019-003520-20, 2024-510745-34-00 | Ph 2, Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid |
| NCT03935971 results posted | 2018P002882 | Ph 4 | active not recruiting | The Effects of Dupilumab on Allergic Contact Dermatitis |
| NCT03694158 IDEA | P00029072 U01AI143514 | Ph 4 | active not recruiting | Investigating Dupilumab's Effect in Asthma by Genotype |
| NCT05866562 PEDAL | 23-00744 | Ph 2 | recruiting | Dupilumab in the Treatment of Pediatric Alopecia Areata |
| NCT05436535 LEADS | DAIT ADRN-12 | Ph 4 | completed | Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysis |
| NCT05964465 | Pro00125142 | Ph 4 | completed | Mechanisms of Smell Improvement With Dupilumab. |
| NCT07399067 | CIBI3002B201 | Ph 2 | recruiting | A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis |
| NCT06687967 | EFC18365 2024-514737-37-00, U1111-1307-7329 | Ph 3 | active not recruiting | A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 1) |
| NCT06687980 | EFC18366 2024-514762-39, U1111-1310-5045 | Ph 3 | active not recruiting | A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 2) |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05347771 PANDA | DAIT CAUSE-01 | Ph 2 | active not recruiting | Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents |
| NCT06293053 | PKM17836 U1111-1287-7255 | Ph 3 | recruiting | A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis |
| NCT06012448 | HUM00227361 | Ph 4 | completed | The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction |
| NCT04148352 results posted | IRB-52976 | Ph 2 | terminated | Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy |
| NCT05590585 DISCOVER results posted | R668-AD-2217 | Ph 4 | completed | Dupilumab in Adolescent and Adult Skin of Color Participants: Open-label Moderate-to-severe Eczema Trial |
| NCT06101095 | LPS17558 U1111-1280-5266, 2022-502491-23 | Ph 4 | 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) |
| NCT05013450 | STUDY-21-00907 | Ph 1, Ph 2 | active not recruiting | Dupilumab_Metastatic NSCLC |
| NCT05731128 | ACT17746 U1111-1278-4042 | Ph 2 | active not recruiting | A Study to Investigate the Efficacy and Safety of Dupilumab Therapy Compared With Placebo in Participants Aged ≥18 Years With Moderately to Severely Active Ulcerative Colitis With an Eosinophilic Phenotype (LIBERTY-UC SUCCEED (Study in UC for Clinical Efficacy Evaluation of Dupilumab)) |
| NCT07091175 SMART-NS | SMART-NS 01 2024/00054 | Ph 2 | recruiting | Dupilumab Therapy in Nephrotic Syndrome in Children |
| NCT07187089 BUILD-PEDS | R668-AD-2372 | Ph 4 | withdrawn | Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab |
| NCT05526521 results posted | PKM16982 U1111-1266-5669, 2022-000260-22 | Ph 3 | completed | 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) |
| NCT05535738 | STUDY00000321 | Ph 2, Ph 3 | active not recruiting | Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation |
| NCT03293030 results posted | Dupilumab Immunogenetics | Ph 4 | completed | Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis |
| NCT05247866 results posted | 21-019416 | Ph 4 | completed | Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis |
| NCT04743791 | STUDY20020131 | Ph 4 | recruiting | Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma |
| NCT05268107 | HUM00201405/Derm 759 | Ph 4 | recruiting | Ethnic Differences in Mechanisms of Action of Dupilumab |
| NCT04362501 | IRB00229130 | Ph 2 | completed | Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) |
| NCT04394351 EoE KIDS results posted | R668-EE-1877 2019-003078-24 | Ph 3 | completed | Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) |
| NCT04998604 EVEREST results posted | LPS16747 U1111-1255-4713, 2021-000829-27 | Ph 4 | completed | EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients |
| NCT05831176 ENGAGE | R668-EGE-2213 2022-500795-62-00 | Ph 2 | active not recruiting | A Study to Learn How Well Dupilumab Works in Adult and Adolescent Participants With Eosinophilic Gastritis With or Without Eosinophilic Duodenitis and the Side Effects it May Have |
| NCT06004986 DUPI REDUCE | 2023-504171-24-00 | Ph 4 | recruiting | DUPIlumab Dose REDUCtion in Patients With Controlled Atopic Eczema |
| NCT05878093 results posted | EFC17026 U1111-1256-9711 | Ph 3 | completed | Dupilumab in Chinese Adult Participants With CRSwNP |
Showing 50 of 125 trials
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DUPIXENT FDA Label Details
Indications & Usage
FDA Label (PDF)DUPIXENT is indicated for the treatment of Atopic Dermatitis; Asthma; Chronic Rhinosinusitis; Eosinophilic Esophagitis; Prurigo Nodularis.
Pro Intelligence Preview
Deep insights for DUPIXENT
Revenue Insights
- • Q4-2025: $4.7B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • 130 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment