Last update 04 Nov 2024

Dupilumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Dupilumab (Genetical Recombination), Dupilumab (genetical recombination) (JAN), Dupilumab (USAN)
+ [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),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Priority Review (AU), Priority Review (US), Priority Review (CN)
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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
EU
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
IS
03 Jul 2024
Pulmonary Disease, Chronic Obstructive
LI
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
EU
26 Sep 2017
Asthma
IS
26 Sep 2017
Asthma
LI
26 Sep 2017
Asthma
NO
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
EU
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
IS
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
LI
26 Sep 2017
Chronic rhinosinusitis with nasal polyps
NO
26 Sep 2017
Dermatitis, Atopic
US
28 Mar 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Eosinophilic DuodenitisPhase 3
US
03 May 2023
Eosinophilic DuodenitisPhase 3
US
03 May 2023
Eosinophilic DuodenitisPhase 3
JP
03 May 2023
Eosinophilic DuodenitisPhase 3
JP
03 May 2023
Eosinophilic DuodenitisPhase 3
AU
03 May 2023
Eosinophilic DuodenitisPhase 3
AU
03 May 2023
Eosinophilic DuodenitisPhase 3
CA
03 May 2023
Eosinophilic DuodenitisPhase 3
CA
03 May 2023
Eosinophilic DuodenitisPhase 3
IT
03 May 2023
Eosinophilic DuodenitisPhase 3
IT
03 May 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
151
mbhzktcbrr(nxvmjprvxi) = hxsaywtasa oihpouxnkh (jhfhnypcgi )
Positive
24 Oct 2024
Placebo
mbhzktcbrr(nxvmjprvxi) = oabbujotwc oihpouxnkh (jhfhnypcgi )
Phase 4
15
tjexnpejwr(niywoujmcp) = lumpmkdmfi dsfyqvsifw (ogasicbkre, wpiibtlsmd - shtdvfloot)
-
23 Oct 2024
NEWS
ManualManual
Not Applicable
106
hxrcegsbuc(hpbbeiyzpz) = kpfxwpbtlm lrmajkbhtn (eykqnhhztl )
Met
Positive
11 Sep 2024
Placebo
hxrcegsbuc(hpbbeiyzpz) = lvulchgtgf lrmajkbhtn (eykqnhhztl )
Met
Phase 3
151
hxwrfableq(srpisbeuph) = tclfepspko fdnstsomak (dzpqbuxcur )
Met
Positive
11 Sep 2024
Placebo
(Study C)
hxwrfableq(srpisbeuph) = ynqswdzgqn fdnstsomak (dzpqbuxcur )
Met
Not Applicable
-
ptviojtjmr(sinljkriyg) = woszncfkxe jvwvdgbxqk (onacxuytcx )
Positive
27 Aug 2024
Placebo
-
Phase 3
102
placebo+dupilumab
(Part A: Pooled Placebo)
xzpseoilsu(ozwmfmjogj) = cuhmhjcyns yxvnakrejg (sigkczlvwr, hshmuvumbv - psnqvalhdc)
-
27 Aug 2024
(Part A: Dupilumab High Dose)
xzpseoilsu(ozwmfmjogj) = rlhlxvamds yxvnakrejg (sigkczlvwr, apjqbvetnt - exzuohmyir)
Phase 2
62
Placebo
fpsvqmgedx(ofhbcecqgz) = nzmjnnqozi vyhkwctrfk (jseexmgiho, umdvkvprem - eclbnzufbg)
-
21 Aug 2024
Not Applicable
1,286
rdjfhiknrw(gxkkxzvbmr) = bltahvajte wudynvdbkz (sxfxaoevvb )
Positive
07 Aug 2024
Phase 3
303
vhzmjzmthe(uoxzjrfvgt) = zcgwjfmbac zfjwmwqyof (tpnonzkfpc )
Positive
01 Aug 2024
Placebo
vhzmjzmthe(uoxzjrfvgt) = okikjewzyg zfjwmwqyof (tpnonzkfpc )
Phase 3
Chronic Urticaria
serum total IgE levels
138
qtvxeakcqr(vaxzvhrprk) = khhxhpfies wuvsltsova (jjhqghvbfu, -41.9 to -22.6)
Positive
27 Jul 2024
Placebo
qtvxeakcqr(vaxzvhrprk) = olksjowrvv wuvsltsova (jjhqghvbfu, -21.3 to 14.9)
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