Dupilumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Dupilumab
- dupixent
- Dupixent
- regn668 sar231893
- Regn668, sar231893
- dupilumab
- Dupilumab
- Dupilumab (blinded)
- Dupilumab (SAR231893/REGN668)
- dupilumab [INN]
- DUPILUMAB [JAN]
- DUPILUMAB [MI]
- DUPILUMAB [PURPLE BOOK CDER]
- DUPILUMAB [USAN]
- Dupilumab [WHO-DD]
- Dupilumab 300 mg
- Dupilumab 300Mg Solution for Injection
- Dupilumab Injection
- dupilumab inn
- dupilumab jan
- dupilumab mi
- dupilumab purple book cder
- Dupilumab SAR231893 (REGN668)
- Dupilumab SAR231893/REGN668
- dupilumab usan
- dupilumab who dd
- Dupixent
- Dupixent®
- DUPIXENT®
- DUPIXENT® (dupilumab)
And 13 more, listed on the interactive page.
- ATC classification codes
- D11AH05
Sources for recorded values
- CAS registry numbers
- 1190264-60-8
- ChEMBL ID
- CHEMBL2108675
- RxNorm IDs (RxCUI)
- 1876376
- FDA ingredient codes (UNII)
- 420K487FSG
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 28 Mar 2017
- Application number
- BLA761055
- Status
- Authorised
- Status date
- 26 Sept 2017
- Authorisation date
- 26 Sept 2017
- Approved indications
- Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma Adults and adolescents Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Children 6 to 11 years of age Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Prurigo Nodularis (PN) Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. Eosinophilic esophagitis (EoE) Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Chronic obstructive pulmonary disease (COPD) Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Chronic Spontaneous Urticaria (CSU) Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents and children (2 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.
- Product number
- EMEA/H/C/004390
- Authorisation holder
- Sanofi Winthrop Industrie
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Asthma
- Dermatitis, Atopic
- Esophageal Diseases
- Prurigo
- Sinusitis
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 25 Jan 2031
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- dupilumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Interleukin-4 receptor subunit alpha antagonist
- Action type
- Antagonist
- Target
- Interleukin-4 receptor subunit alpha
- Protein identifier
- P24394
- Action
- Binding
- Action type
- Binding
- Target
- Interleukin-4 receptor subunit α
- Gene symbol
- IL4R
- Protein identifier
- P24394
- Median affinity
- 10.93
- Affinity units
- pKd
Open Targets mechanisms
- Mechanism
- Interleukin-4 receptor subunit alpha antagonist
- Action type
- Antagonist
- Target
- Interleukin-4 receptor subunit alpha
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Respiratory Tract Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000684
- Subject identifier
- D012140
- Condition
- Skin Diseases
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000701
- Subject identifier
- D012871
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Alopecia Areata
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004192
- Subject identifier
- D000506
- Condition
- Keloid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004212
- Subject identifier
- D007627
- Condition
- Eosinophilic Esophagitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004232
- Subject identifier
- D057765
- Condition
- Urticaria
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005531
- Subject identifier
- D014581
- Condition
- Angioedema
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005532
- Subject identifier
- D000799
- Condition
- Rhinitis, Allergic, Seasonal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005854
- Subject identifier
- D006255
- Condition
- Aspergillosis, Allergic Bronchopulmonary
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007140
- Subject identifier
- D001229
- Condition
- Conjunctivitis, Allergic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007141
- Subject identifier
- D003233
- Condition
- Pemphigoid, Bullous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007187
- Subject identifier
- D010391
- Condition
- Peanut Hypersensitivity
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007425
- Subject identifier
- D021183
- Condition
- Sinusitis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0007486
- Subject identifier
- D012852
- Condition
- Esophageal Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009544
- Subject identifier
- D004935
- Condition
- Nasal Polyps
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000391
- Subject identifier
- D009298
- Condition
- Neurodermatitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000740
- Subject identifier
- D009450
- Condition
- Scleroderma, Localized
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001361
- Subject identifier
- D012594
- Condition
- Hypereosinophilic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001467
- Subject identifier
- D017681
- Condition
- Cold Urticaria
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001881
- Subject identifier
- D000096703
- Condition
- Food Hypersensitivity
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001890
- Subject identifier
- D005512
- Condition
- Eczema
- Highest recorded phase
- 4
- Condition identifier
- HP:0000964
- Subject identifier
- D004485
And 10 more, listed on the interactive page.
- Condition identifier
- EFO_0000274
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000684
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000701
- Condition identifier
- EFO_0000729
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0004192
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004212
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004232
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005414
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005531
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005854
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007140
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007141
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007187
- Condition identifier
- EFO_0007425
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007486
- Condition identifier
- EFO_0009544
- Condition identifier
- EFO_1000391
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000740
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001361
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001467
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001881
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001890
- Highest recorded phase
- 2
- Condition identifier
- EFO_1002029
And 52 more, listed on the interactive page.
- Event
- arthralgia
- Reports
- 535
- Reporting signal score
- 197.774
- Event
- blepharitis
- Reports
- 87
- Reporting signal score
- 242.584
- Event
- condition aggravated
- Reports
- 421
- Reporting signal score
- 148.621
- Event
- conjunctivitis
- Reports
- 841
- Reporting signal score
- 2,818.53
- Event
- cutaneous t-cell lymphoma
- Reports
- 42
- Reporting signal score
- 141.931
- Event
- dermatitis
- Reports
- 150
- Reporting signal score
- 262.729
- Event
- dermatitis atopic
- Reports
- 373
- Reporting signal score
- 1,414.56
- Event
- diarrhoea
- Reports
- 89
- Reporting signal score
- 142.999
- Event
- dry eye
- Reports
- 222
- Reporting signal score
- 386.017
- Event
- eczema
- Reports
- 275
- Reporting signal score
- 536.476
- Event
- eosinophil count increased
- Reports
- 115
- Reporting signal score
- 228.642
- Event
- eosinophilia
- Reports
- 109
- Reporting signal score
- 116.821
- Event
- eosinophilic granulomatosis with polyangiitis
- Reports
- 56
- Reporting signal score
- 177.125
- Event
- erythema
- Reports
- 437
- Reporting signal score
- 333.671
- Event
- eye discharge
- Reports
- 74
- Reporting signal score
- 149.658
- Event
- eye disorder
- Reports
- 100
- Reporting signal score
- 120.991
- Event
- eye irritation
- Reports
- 186
- Reporting signal score
- 300.226
- Event
- eye pain
- Reports
- 120
- Reporting signal score
- 125.2
- Event
- eye pruritus
- Reports
- 247
- Reporting signal score
- 545.475
- Event
- eye swelling
- Reports
- 115
- Reporting signal score
- 130.328
- Event
- injection site reaction
- Reports
- 219
- Reporting signal score
- 153.662
- Event
- injection site urticaria
- Reports
- 103
- Reporting signal score
- 124.014
- Event
- keratitis
- Reports
- 60
- Reporting signal score
- 135.007
- Event
- lacrimation increased
- Reports
- 120
- Reporting signal score
- 170.082
- Event
- nausea
- Reports
- 149
- Reporting signal score
- 125.8
And 6 more, listed on the interactive page.
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And 83 more, listed on the interactive page.
- Dose
- 300 mg
- Route
- Subcutaneous
- How often
- Every 2 weeks (Q2W)
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0024-5914
- 0024-5915
- 0024-5918
- 0024-5919
Related records
Trials (250)
- A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
- A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
- A First In Human (FIH) Study of IBI356 in Healthy Participants and in Atopic Dermatitis Patients
- A Long-term Data Collection Study of Participants in France Aged 6 Years Old or More With Atopic Dermatitis Receiving Dupilumab
- A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD
- A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany
- A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety and Patient Reported Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine
- A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Injection
- A Phase 4, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
- A Phase I Study of 9MW4113 Injection Versus Dupixent®
- A Phase Ⅲ Comparative Study of QL2108 to Dupixent®
- A Phase III Study of GS101 Injection to Dupixent®
- A PhaseⅠ Comparative Study to Evaluate the Pharmacokinetics of QL2108 to Dupixent®
- A Pilot Study of the Efficacy and Safety of Dupilumab Versus Placebo in Patients With Netherton Syndrome
- A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
- A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
- A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)
- A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
- A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis
- A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis
Approved for (6)
- Asthma
- Atopic eczema
- Esophageal disorder
- Nasal cavity polyp
- Prurigo
- Sinusitis
In development for (28)
- Allergic asthma Phase 2
- Allergic bronchopulmonary aspergillosis Phase 2
- Allergic disease Phase 2
- Allergic rhinitis Phase 2
- Alopecia areata Phase 2
- Angioedema Phase 2
- Atopic conjunctivitis Phase 2
- Breast cancer Phase 2
- Bullous pemphigoid Phase 2
- Chronic idiopathic urticaria Phase 3
- Chronic obstructive pulmonary disease Phase 3
- Cold urticaria Phase 3
- COVID-19 Phase 2
- Dermatitis Phase 3
- Eosinophilic esophagitis Phase 3
- Food allergy Phase 1
- Hypereosinophilic syndrome Phase 2
- Keloid Phase 2
- Localized scleroderma Phase 2
- Netherton syndrome Phase 2
Targets (1)
- IL4R Interleukin-4 receptor subunit alpha antagonist