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Dupilumab (SAR231893)
Dupilumab is a monoclonal antibody that blocks the IL-4 receptor alpha subunit, inhibiting signaling of interleukin-4 and interleukin-13, key drivers of type 2 inflammation.
Dupilumab is a monoclonal antibody that blocks the IL-4 receptor alpha subunit, inhibiting signaling of interleukin-4 and interleukin-13, key drivers of type 2 inflammation. Used for Moderate-to-severe atopic dermatitis, Moderate-to-severe asthma with type 2 inflammation, Chronic rhinosinusitis with nasal polyps.
At a glance
| Generic name | Dupilumab (SAR231893) |
|---|---|
| Also known as | REGN668, Dupixent |
| Sponsor | Sanofi |
| Drug class | IL-4 receptor antagonist monoclonal antibody |
| Target | IL-4 receptor alpha (IL-4Rα) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
By antagonizing IL-4 receptor alpha, dupilumab suppresses the IL-4 and IL-13 pathways that promote type 2 immune responses, reducing eosinophil recruitment, IgE production, and inflammatory mediator release. This mechanism addresses the underlying pathophysiology of allergic and eosinophilic diseases characterized by type 2 inflammation.
Approved indications
- Moderate-to-severe atopic dermatitis
- Moderate-to-severe asthma with type 2 inflammation
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Eosinophilic gastroenteritis
- Prurigo nodularis
Common side effects
- Injection site reactions
- Conjunctivitis
- Headache
- Oropharyngeal pain
- Upper respiratory tract infection
Key clinical trials
- A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. (PHASE4)
- A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
- Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid (PHASE2, PHASE3)
- A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis (PHASE3)
- Registry of Asthma Patients Initiating DUPIXENT®
- Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
- 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 (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dupilumab (SAR231893) CI brief — competitive landscape report
- Dupilumab (SAR231893) updates RSS · CI watch RSS
- Sanofi portfolio CI