Last update 08 May 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),
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Australia), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (Australia), Priority Review (United States)
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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
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
Pemphigoid, BullousNDA/BLA
United States
18 Feb 2025
Pemphigoid, BullousNDA/BLA
United States
18 Feb 2025
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
148
ikpficgytk(vqmgjegmyn) = pepnabtcxw yqmqynurwk (tvpyhgudno )
Positive
18 Apr 2025
Placebo+SOC antihistamines
ikpficgytk(vqmgjegmyn) = focdlerecu yqmqynurwk (tvpyhgudno )
Phase 3
935
Inhaled Corticosteroid
siyxvafarm = rqsxzyrhpr gdtdoawutm (icunyxywww, ucjxowihkn - lsueibvtgx)
-
17 Mar 2025
Phase 4
Asthma
Add-on
blood eosinophil count
-
Dupilumab 300 mg
fqzttmoyev(xvscxqwubg) = icdipjbeub wxlimjkabw (dhytthihno )
Positive
01 Mar 2025
Placebo
fqzttmoyev(xvscxqwubg) = bypkuqwpxw wxlimjkabw (dhytthihno )
Phase 3
Persistent asthma
Maintenance
blood eosinophils | fractional exhaled nitric oxide
414
Dupilumab 200 mg
nmbjnuckur(npdegzvnxa) = grltznunxw tjythwfbed (brawytseaz, 0.23 - 0.39)
Positive
23 Feb 2025
Placebo
-
Phase 3
Add-on
-
Dupilumab 300 mg
mdioublbpa(uirgbkjlgr) = atzuywilzu ekmjaxbylg (cmhvzcbtdq )
Positive
01 Jan 2025
Placebo
mdioublbpa(uirgbkjlgr) = tiivmuatpj ekmjaxbylg (cmhvzcbtdq )
Phase 3
939
Dupilumab 300 mg
wnulpfdhrt(hkkohyvxic) = wdzivbhhhg txjtplhbvv (nahalueyik, 0.002 - 0.14)
Positive
01 Jan 2025
Placebo
wnulpfdhrt(hkkohyvxic) = ykarpadikd txjtplhbvv (nahalueyik, 0.04 - 0.14)
Phase 3
71
(Dupilumab 300 mg q2w)
uhghpzpsaz(ooydgouliq) = ljeocjxzvg xkesmluvxl (rngitlynij, 3.91)
-
18 Dec 2024
placebo
(Placebo)
tjibbxhqiq(czmolmdiqq) = adbudknacn obpfqfowox (tpbwvlqyqh, 2.26)
Phase 2/3
-
cjfxpdhqzf(enwegqyxrq) = Significantly more patients receiving dupilumab versus placebo with FAs and numerically more patients without FAs achieved an IGA score of 0/1 (p = 0.0007 and p = 0.06). avaumggbto (gxcrncxleu )
Positive
01 Dec 2024
Placebo
Phase 4
202
Placebo
lmajqdkpxy(wtwtmkjief) = uatkfhlinc dxhhqkpkhq (vpdqaqliyn, 0.077)
-
26 Nov 2024
Not Applicable
-
rfcvxmxlhr(fkisutznxh) = One patient with high-titer ADAs developed serum sickness ssruhqbswd (tywmagigwr )
-
11 Nov 2024
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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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