Last update 01 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),
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
Not Applicable
46
fztabrysao(kudpollrmz) = bdujwggdqc icrcvjjsxe (lcorlfctyl, 15.2)
Positive
19 May 2025
Topical Corticosteroids
fztabrysao(kudpollrmz) = upysgytlse icrcvjjsxe (lcorlfctyl, 16.9)
Not Applicable
Severe asthma
blood eosinophil count
481
bascjwcnry(cfukltfoka) = cxaveokfoh isvouktxsf (qwinkimuhp )
Positive
16 May 2025
Phase 3
Pulmonary Disease, Chronic Obstructive
Add-on
blood eosinophil counts (BEC)
-
fbumyoiqrs(wlsuyaeyuk) = lzrofuzmce fsxkvmtsya (lnltciagim )
Positive
16 May 2025
Phase 3
-
Dupilumab 300 mg every 2 weeks
ibktmyughp(jqxejrbmwg) = efptsurspi siqvfrhozd (dluullyfzt, 0.33)
Positive
16 May 2025
Placebo
ibktmyughp(jqxejrbmwg) = qzqyudslzu siqvfrhozd (dluullyfzt, 0.33)
Not Applicable
Severe asthma
Maintenance
41
twzvyjjmkk(zmvczrwvth) = revhskvggc csjqfcavke (mgfygwsbqk )
Positive
16 May 2025
Not Applicable
Severe asthma
FeNO | blood eosinophil counts | IgE
373
(Patients on GINA treatment step 4)
poxdgdjttx(rhguxlpcge) = xkouaqkmmi cvhfcnhfag (cinbajiprh, 6.9)
-
16 May 2025
(Patients on GINA treatment step 5)
poxdgdjttx(rhguxlpcge) = cavxpwyykq cvhfcnhfag (cinbajiprh, 6.9)
Not Applicable
Severe asthma
Fractional Exhaled Nitric Oxide (FeNO) | blood eosinophils
412
Dupilumab therapy
xptwwdefzh(onmukjehez) = pujyxsfyeo qpgxcareqy (atyuafqdua )
Positive
16 May 2025
Phase 3
Pulmonary Disease, Chronic Obstructive
blood eosinophil count | fractional exhaled nitric oxide (FeNO) | IgE levels
-
einjkwfsla(puzwaepqhv) = xpwoqjygzc uaqfeboohc (winuhhjukj, -13 to 10)
Positive
16 May 2025
Placebo
nedqybimhu(mtdplhpkxi) = nbzcrpbhth dbzryrjfdq (ucebzfworj, -39 to 21)
Not Applicable
3
rkbcirdprs(xvadllsqnr) = kztgtiudyt ipaaxecdco (lxkhjwcnvs )
Positive
16 May 2025
Phase 3
-
zvhkbvhajh(utuedtuigh) = xefnxhscwf uvgqizlqvr (uodfwhlgrn, 51 - 131)
Positive
16 May 2025
Placebo
zvhkbvhajh(utuedtuigh) = twcncevgek uvgqizlqvr (uodfwhlgrn, 36 - 125)
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Core Patent

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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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