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Dupixent (DUPILUMAB)
Dupixent blocks the interleukin-4 receptor, a key player in the immune system's inflammatory response.
Dupixent (Dupilumab) is a biologic medication developed by Regeneron Pharmaceuticals, targeting the interleukin-4 receptor subunit alpha. It works as an interleukin-4 receptor alpha antagonist, modulating the immune system's response to reduce inflammation. Dupixent is approved to treat various conditions, including asthma, atopic dermatitis, chronic sinusitis, eosinophilic esophagitis, and prurigo nodularis. The medication is patented and commercially available, with key safety considerations including potential increased risk of infections and allergic reactions. As a biologic medication, Dupixent is not a small molecule.
At a glance
| Generic name | DUPILUMAB |
|---|---|
| Sponsor | Regeneron |
| Drug class | Interleukin-4 Receptor alpha Antagonist [EPC] |
| Target | Interleukin-4 receptor subunit alpha |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 14600 |
Mechanism of action
Dupilumab is human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4R subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type receptor and both IL-4 and IL-13 signaling through the Type II receptor.Inflammation driven by IL-4 and IL-13 is an important component in the pathogenesis of asthma, atopic dermatitis, and CRSwNP. Multiple cell types that express IL-4R (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL-4R with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE. The mechanism of dupilumab action in asthma has not been definitively established.
Approved indications
- Asthma
- Atopic dermatitis
- Chronic sinusitis
- Eosinophilic esophagitis
- Prurigo nodularis
Common side effects
- Injection site reaction
- Conjunctivitis
- Blepharitis
- Oral herpes
- Keratitis
- Eye pruritus
- Other herpes simplex virus infection
- Dry eye
- Eosinophilia
- Oropharyngeal pain
- Insomnia
- Toothache
Key clinical trials
- Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (PHASE3)
- A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps (PHASE3)
- Evaluation of Dupilumab in Children With Uncontrolled Asthma (PHASE3)
- 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) (PHASE3)
- A Study to Confirm the Efficacy and Safety of Different Dupilumab Dose Regimens in Adults With Atopic Dermatitis (AD) (PHASE3)
- Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis (PHASE3)
- Study of Dupilumab (REGN668/SAR231893) Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis (PHASE3)
- An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dupixent CI brief — competitive landscape report
- Dupixent updates RSS · CI watch RSS
- Regeneron portfolio CI