DUPIXENT
DUPIXENT (dupilumab) is an interleukin-4 receptor alpha antagonist indicated for the treatment of several chronic inflammatory conditions in both adult and pediatric patients. It is used to manage moderate-to-severe atopic dermatitis, asthma, and chronic obstructive pulmonary disease, as well as eosinophilic esophagitis and prurigo nodularis. The medication also serves as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, bullous pemphigoid, and allergic fungal rhinosinusitis. It is generally prescribed when patients are inadequately controlled by standard therapies, though it is not indicated for the relief of acute bronchospasm.
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.
Details
- Status
- Prescription
- First Approved
- 2017-03-28
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DUPIXENT Approval History
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
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.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
ProIndications & Usage
FDA Label (PDF)DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. Asthma as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. Limitations of...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.