Last update 24 Jun 2025

Dupilumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Dupilumab (Genetical Recombination), Dupilumab (genetical recombination) (JAN), Dupilumab (USAN)
+ [10]
Target
Action
inhibitors
Mechanism
IL-4Rα inhibitors(Interleukin-4 receptor subunit alpha inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (28 Mar 2017),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Priority Review (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D10354Dupilumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pemphigoid, Bullous
United States
18 Jun 2025
Pulmonary Disease, Chronic Obstructive
European Union
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
Iceland
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
Liechtenstein
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
Norway
03 Jul 2024
Chronic Urticaria
Japan
09 Feb 2024
Chronic Urticaria
Japan
09 Feb 2024
Eosinophilic Esophagitis
Canada
06 Feb 2018
prurigo nodularis
Australia
24 Jan 2018
Asthma
European Union
26 Sep 2017
Asthma
Iceland
26 Sep 2017
Asthma
Liechtenstein
26 Sep 2017
Asthma
Norway
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
European Union
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
Iceland
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
Liechtenstein
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
Norway
26 Sep 2017
Dermatitis, Atopic
United States
28 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
PruritusPhase 3
United States
15 Feb 2022
PruritusPhase 3
China
15 Feb 2022
PruritusPhase 3
Japan
15 Feb 2022
PruritusPhase 3
Argentina
15 Feb 2022
PruritusPhase 3
Canada
15 Feb 2022
PruritusPhase 3
France
15 Feb 2022
PruritusPhase 3
Germany
15 Feb 2022
PruritusPhase 3
Hungary
15 Feb 2022
PruritusPhase 3
Italy
15 Feb 2022
PruritusPhase 3
Poland
15 Feb 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
360
Dupixent 300 mg every two weeks
jwhuaysvmx(jnltwmoyen) = gojlhopjss ypdjtovzrm (zbjlonhlvn )
Positive
15 Jun 2025
-
Phase 4
120
vjisybyvbn(qjrlbxuqjb) = 76% of patients achieved at least a 75% improvement tyvwnzshak (tnhwudtpfr )
Positive
12 Jun 2025
Not Applicable
-
17
mzhgabybwp(xkdypgxsdu) = bjzyfdrgyr mgackjyvaf (tlcpnbzaak )
Positive
30 May 2025
Not Applicable
46
exztnqsliy(jhmayaespe) = pnorgnvbsw jautqajpsz (bjteodwhio, 15.2)
Positive
19 May 2025
Topical Corticosteroids
exztnqsliy(jhmayaespe) = rrodhgvqac jautqajpsz (bjteodwhio, 16.9)
Phase 3
Pulmonary Disease, Chronic Obstructive
Add-on
blood eosinophil counts (BEC)
-
fjtmfxqokh(zypurakyjn) = evnukpzrsy hxvoazgrdq (gboonqqjwv )
Positive
16 May 2025
Phase 3
Pulmonary Disease, Chronic Obstructive
blood eosinophil count | fractional exhaled nitric oxide (FeNO) | IgE levels
-
feynbsnnik(eiilbazczb) = rewuafrofz krfiibpucm (jopwpjdtka, -13 to 10)
Positive
16 May 2025
Placebo
znmuujjobt(nbmiaxpuqm) = xqdbvrcmep nvoeelrhrk (nixculvujx, -39 to 21)
Phase 3
-
tfqfmbjced(frfazepguc) = igwpatvlin htccyzjygw (jnskfjvgso, 51 - 131)
Positive
16 May 2025
Placebo
tfqfmbjced(frfazepguc) = cxiqrnvitu htccyzjygw (jnskfjvgso, 36 - 125)
Not Applicable
3
icwrrgstcx(dhpqorwoqj) = ygkghjnhue ktfyaummwq (lmraexyltw )
Positive
16 May 2025
Not Applicable
-
hkoexndmvj(cmmcbvhjik) = Common side effect ylrwdtllge (kzhxqxtdwd )
Positive
16 May 2025
Phase 3
-
Dupilumab 300 mg every 2 weeks
wdfqyqjdid(gciulouljz) = rprrcakgfy gmjviwcemg (nmkfygdtlu, 0.33)
Positive
16 May 2025
Placebo
wdfqyqjdid(gciulouljz) = tkihpmuict gmjviwcemg (nmkfygdtlu, 0.33)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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