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Dupilumab (SAR231893/REGN668)
Dupilumab (SAR231893/REGN668) is a Monoclonal antibody; IL-4 receptor antagonist Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Moderate-to-severe atopic dermatitis, Moderate-to-severe asthma (particularly type 2/eosinophilic), Chronic rhinosinusitis with nasal polyps.
Dupilumab is a monoclonal antibody that blocks the IL-4 receptor alpha subunit, inhibiting signaling of IL-4 and IL-13 cytokines involved in type 2 inflammation.
Dupilumab is a monoclonal antibody that blocks the IL-4 receptor alpha subunit, inhibiting signaling of IL-4 and IL-13 cytokines involved in type 2 inflammation. Used for Moderate-to-severe atopic dermatitis, Moderate-to-severe asthma (particularly type 2/eosinophilic), Chronic rhinosinusitis with nasal polyps.
At a glance
| Generic name | Dupilumab (SAR231893/REGN668) |
|---|---|
| Sponsor | Sanofi |
| Drug class | Monoclonal antibody; IL-4 receptor antagonist |
| Target | IL-4 receptor alpha (IL-4Rα) |
| Modality | Small molecule |
| Therapeutic area | Immunology; Dermatology; Respiratory |
| Phase | Phase 3 |
Mechanism of action
By antagonizing IL-4 receptor alpha, dupilumab suppresses the IL-4/IL-13 signaling pathway, which drives type 2 immune responses and inflammation. This mechanism reduces eosinophil recruitment, IgE production, and other hallmarks of type 2 inflammatory diseases including atopic dermatitis, asthma, and eosinophilic conditions. The drug effectively dampens the underlying Th2-mediated immune dysregulation common to these conditions.
Approved indications
- Moderate-to-severe atopic dermatitis
- Moderate-to-severe asthma (particularly type 2/eosinophilic)
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Common side effects
- Injection site reactions
- Conjunctivitis
- Headache
- Oropharyngeal pain
- Upper respiratory tract infection
Key clinical trials
- A U.S. Registry of Eosinophilic Esophagitis Pediatric, Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care
- 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®
- 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)
- Study of Growth and Bone Mineral Density in Children With Atopic Dermatitis (AD) Treated With Dupilumab (PHASE4)
- Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion) (PHASE3)
- Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) (PHASE3)
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/REGN668) CI brief — competitive landscape report
- Dupilumab (SAR231893/REGN668) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Dupilumab (SAR231893/REGN668)
What is Dupilumab (SAR231893/REGN668)?
How does Dupilumab (SAR231893/REGN668) work?
What is Dupilumab (SAR231893/REGN668) used for?
Who makes Dupilumab (SAR231893/REGN668)?
What drug class is Dupilumab (SAR231893/REGN668) in?
What development phase is Dupilumab (SAR231893/REGN668) in?
What are the side effects of Dupilumab (SAR231893/REGN668)?
What does Dupilumab (SAR231893/REGN668) target?
Related
- Drug class: All Monoclonal antibody; IL-4 receptor antagonist drugs
- Target: All drugs targeting IL-4 receptor alpha (IL-4Rα)
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Immunology; Dermatology; Respiratory
- Indication: Drugs for Moderate-to-severe atopic dermatitis
- Indication: Drugs for Moderate-to-severe asthma (particularly type 2/eosinophilic)
- Indication: Drugs for Chronic rhinosinusitis with nasal polyps
- Compare: Dupilumab (SAR231893/REGN668) vs similar drugs
- Pricing: Dupilumab (SAR231893/REGN668) cost, discount & access