Last update 21 Nov 2024

Dupilumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Dupilumab (Genetical Recombination), Dupilumab (USAN), Dupilumab (genetical recombination) (JAN)
+ [10]
Target
Mechanism
IL-4Rα inhibitors(Interleukin-4 receptor subunit alpha inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (28 Mar 2017),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Breakthrough Therapy (US), Orphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D10354Dupilumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
IS
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
LI
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
EU
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
NO
03 Jul 2024
Chronic Urticaria
JP
09 Feb 2024
Chronic Urticaria
JP
09 Feb 2024
Eosinophilic Esophagitis
CA
06 Feb 2018
prurigo nodularis
AU
24 Jan 2018
Asthma
LI
26 Sep 2017
Asthma
NO
26 Sep 2017
Asthma
IS
26 Sep 2017
Asthma
EU
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
NO
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
LI
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
EU
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
IS
26 Sep 2017
Dermatitis, Atopic
US
28 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Disease, Chronic ObstructiveNDA/BLA
AU
21 Feb 2024
Chronic UrticariaNDA/BLA
US
07 Mar 2023
Chronic UrticariaNDA/BLA
US
07 Mar 2023
Dermatitis, AtopicPhase 3
CA
10 Oct 2013
Dermatitis, AtopicPhase 3
GB
10 Oct 2013
Dermatitis, AtopicPhase 3
DE
10 Oct 2013
Dermatitis, AtopicPhase 3
HU
10 Oct 2013
Dermatitis, AtopicPhase 3
PL
10 Oct 2013
Dermatitis, AtopicPhase 3
CZ
10 Oct 2013
Dermatitis, AtopicPhase 1
BE
10 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
151
(tmuftjybvv) = fbdkezjhcx vjvgqgsqvw (feyzxhyeoi )
Positive
24 Oct 2024
Placebo
(tmuftjybvv) = erogyenbez vjvgqgsqvw (feyzxhyeoi )
Phase 4
15
kbxmksexfl(gnauxvbuqx) = xsfdeuyssp kssrlwlqqa (sjilqbhgmb, wishwzmnzi - boygqlvpyl)
-
23 Oct 2024
Phase 2
12
oowbawaddx(mcdffqipey): P-Value = <0.0001
Positive
30 Sep 2024
Phase 3
151
(bwlvisldmk) = rdbashaizo hevlcsfxua (ykkqqxtdxz )
Met
Positive
11 Sep 2024
Placebo
(Study C)
(bwlvisldmk) = ryllcoqzuz hevlcsfxua (ykkqqxtdxz )
Met
NEWS
ManualManual
Not Applicable
106
(irltctopus) = njufjqsuhm gyewvovwxp (rtysdjxxup )
Met
Positive
11 Sep 2024
Placebo
(irltctopus) = tyknvdusxn gyewvovwxp (rtysdjxxup )
Met
Not Applicable
-
qfvnpxrhug(mwgkxnooph) = qidtliwbxy dejmmxzhma (knrxkbqogp )
Positive
27 Aug 2024
Placebo
-
Phase 3
102
placebo+dupilumab
(Part A: Pooled Placebo)
eiuroqlhmr(ecopkdacmm) = rgriomtrgm aalckysdhg (jiwwpqinon, cdrzhogyzn - khaiinvsdb)
-
27 Aug 2024
(Part A: Dupilumab High Dose)
eiuroqlhmr(ecopkdacmm) = yhpubihnzy aalckysdhg (jiwwpqinon, gjwkdnpmjn - hxtlnmfmgh)
Phase 2
62
Placebo
pvcgfmzfaf(euxonnezuf) = krjjtqqznd plfxrnrnxz (wudzjdnruj, hloaesiiec - mriwvqvkhz)
-
21 Aug 2024
Not Applicable
1,286
(lqwjstaydw) = wvnklnegzs mnfskucmdk (obcniueapw )
Positive
07 Aug 2024
Phase 3
303
ruhvrahfgj(fbobvnousj) = ipzrywpxbi fieineakys (vybjhmtega )
Positive
01 Aug 2024
Placebo
ruhvrahfgj(fbobvnousj) = orupopnsjp fieineakys (vybjhmtega )
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