Overview
Dupilumab is a fully human monoclonal antibody of the immunoglobulin G4 subclass that binds to the interleukin-4 (IL-4) receptor, inhibiting the receptor signaling pathways. As an interleukin-4 receptor alpha antagonist, dupilumab inhibits the signaling of pro-inflammatory cytokines, called interleukins (IL), that induce inflammatory and immunological reactions in several atopic or allergic conditions, such as eczema, allergic reaction, and rhinosinusitis. Dupilumab was generated by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Dupilumab is commonly marketed as Dupixent, which is available as a formulation for subcutaneous injection. It was first approved by the FDA in 2017. It is currently used to treat atopic dermatitis, asthma as an add-on maintenance treatment, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. It is used as monotherapy or in combination with other drugs, such as corticosteroids. Dupilumab is currently under investigations for potential therapeutic use in diseases driven by allergic reactions or type 2 inflammation, such as pediatric atopic dermatitis, and chronic obstructive pulmonary disease. It is also being studied in combination with another antibody that which targets IL-33.
Indication
In the US, dupilumab is indicated for the treatment of patients aged six months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. In Europe and Canada, the drug for this indication is approved for patients aged six years and older. In Europe, patients six to 11 years of age should have severe atopic dermatitis and be candidates for systemic therapy. Dupilumab can be used with or without topical corticosteroids for this condition. Dupilumab is indicated as an add-on maintenance treatment of patients aged six years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. However, the drug is not indicated for relief of acute bronchospasm or status asthmaticus. Dupilumab is indicated as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis. In Canada and Europe, it is used with intranasal corticosteroids. In the US and Europe, dupilumab is also indicated for the treatment of adults and children aged 12 years and older weighing at least 40 kg with eosinophilic esophagitis (EoE), and adults with prurigo nodularis.
Associated Conditions
- Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
- Eosinophilic Esophagitis
- Moderate to Severe Asthma
- Moderate to Severe Atopic Dermatitis
- Oral Steroid-Dependent Asthma (Disorder)
- Prurigo Nodularis
- Severe Asthma
- Severe Atopic Dermatitis
- Moderate Atopic dermatitis
- Moderate Prurigo Nodularis
- Severe Prurigo Nodularis
Research Report
A Comprehensive Monograph on Dupilumab (DB12159)
Part I: Foundational Profile and Molecular Characterization
1.1. Identification and Physicochemical Properties
Dupilumab is a high-impact biologic therapy that has reshaped the treatment landscape for a range of inflammatory diseases. It is a biotechnology-derived product classified as a protein-based therapy, specifically a monoclonal antibody (mAb).[1]
- Generic Name: Dupilumab [1]
- Brand Name: The medication is marketed globally under the brand name Dupixent®.[1]
- Unique Identifiers:
- DrugBank ID: DB12159 [1]
- CAS Number: 1190264-60-8 [2]
- Development Codes and Synonyms: During its development, Dupilumab was known by the codes REGN-668 and SAR-231893.[7]
- Chemical and Physical Properties:
- Molecular Formula: The empirical formula for Dupilumab is C6512H10066N1730O2052S46.[2]
- Molecular Weight: As a large protein molecule, its molecular weight is approximately 147,000 Daltons (147 kDa).[6] More precise calculations place the molecular weight at 146,897.04 Da, with an exact mass of 146,806.3649 Da.[2]
- Appearance: In its final formulation, Dupilumab is a clear to slightly opalescent, colorless to pale yellow solution, free from visible particulates.[10]
1.2. Structural and Formulation Details
The therapeutic function and clinical profile of Dupilumab are intrinsically linked to its specific molecular structure and pharmaceutical formulation.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/08 | Not Applicable | Not yet recruiting | |||
2025/07/29 | Not Applicable | Not yet recruiting | |||
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/07/04 | N/A | Not yet recruiting | |||
2025/06/18 | Phase 1 | Recruiting | |||
2025/06/17 | N/A | Recruiting | |||
2025/04/22 | N/A | Active, not recruiting | |||
2025/03/25 | N/A | Recruiting | |||
2025/03/19 | Phase 3 | Not yet recruiting | |||
2025/03/18 | Phase 2 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| sanofi-aventis U.S. LLC | 0024-5911 | SUBCUTANEOUS | 100 mg in 0.67 mL | 6/18/2025 | |
| sanofi-aventis U.S. LLC | 0024-5914 | SUBCUTANEOUS | 300 mg in 2 mL | 6/18/2025 | |
| sanofi-aventis U.S. LLC | 0024-5918 | SUBCUTANEOUS | 200 mg in 1.14 mL | 6/18/2025 | |
| sanofi-aventis U.S. LLC | 0024-5915 | SUBCUTANEOUS | 300 mg in 2 mL | 6/18/2025 | |
| sanofi-aventis U.S. LLC | 0024-5919 | SUBCUTANEOUS | 200 mg in 1.14 mL | 6/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 9/26/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 mg/2ml | SIN15675P | INJECTION, SOLUTION | 300 mg/2ml | 4/29/2019 | |
| DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 100MG/0.67ML | SIN16458P | INJECTION, SOLUTION | 100mg/0.67mL | 3/30/2022 | |
| DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 200 mg/1.14ml | SIN16121P | INJECTION, SOLUTION | 200mg per 1.14mL | 3/15/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| DUPIXENT SOLUTION FOR INJECTION IN PRE-FILLED PEN 200MG/1.14ML | N/A | N/A | N/A | 3/25/2025 | |
| DUPIXENT SOLUTION FOR INJECTION IN PRE-FILLED PEN 300MG/2ML | N/A | N/A | N/A | 3/25/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DUPIXENT dupilumab 300 mg (150 mg/mL) solution for injection pre-filled pen | 382594 | Medicine | A | 6/3/2022 | |
| DUPIXENT dupilumab (rch) 300 mg/2 mL solution for injection pre-filled syringe with needle shield | 283127 | Medicine | A | 1/24/2018 | |
| DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled syringe with needle shield | 302463 | Medicine | A | 5/28/2019 | |
| DUPIXENT dupilumab 200 mg (175 mg/mL) solution for injection pre-filled pen | 382593 | Medicine | A | 6/3/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DUPIXENT | sanofi-aventis canada inc | 02492504 | Solution - Subcutaneous | 200 MG / 1.14 ML | 11/29/2019 |
| DUPIXENT | sanofi-aventis canada inc | 02524252 | Solution - Subcutaneous | 200 MG / 1.14 ML | 6/23/2022 |
| DUPIXENT | sanofi-aventis canada inc | 02510049 | Solution - Subcutaneous | 300 MG / 2 ML | 5/27/2021 |
| DUPIXENT | sanofi-aventis canada inc | 02470365 | Solution - Subcutaneous | 300 MG / 2 ML | 2/6/2018 |
| DUPIXENT | sanofi-aventis canada inc | 02526190 | Solution - Subcutaneous | 100 MG / 0.67 ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DUPIXENT 200 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1171229010 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized | |
| DUPIXENT 200 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1171229014 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized | |
| DUPIXENT 300 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1171229018 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized | |
| DUPIXENT 300 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1171229006 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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