Last update 24 Dec 2024

Benralizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Benra, Benralizumab (Genetical Recombination), Benralizumab (genetical recombination) (JAN)
+ [10]
Target
Mechanism
IL-5Rα inhibitors(Interleukin-5 receptor subunit alpha inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
US (14 Nov 2017),
RegulationFast Track (US), Orphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Churg-Strauss Syndrome
US
17 Sep 2024
Severe asthma
US
17 Sep 2024
Eosinophilic Asthma
EU
08 Jan 2018
Eosinophilic Asthma
IS
08 Jan 2018
Eosinophilic Asthma
LI
08 Jan 2018
Eosinophilic Asthma
NO
08 Jan 2018
Asthma
US
14 Nov 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
SinusitisNDA/BLA
US
14 Mar 2022
Eosinophilic EnteropathyPhase 3
US
18 Jan 2022
Eosinophilic EnteropathyPhase 3
JP
18 Jan 2022
Eosinophilic EnteropathyPhase 3
BR
18 Jan 2022
Eosinophilic EnteropathyPhase 3
IT
18 Jan 2022
Eosinophilic EnteropathyPhase 3
NL
18 Jan 2022
Eosinophilic EnteropathyPhase 3
PL
18 Jan 2022
Eosinophilic EnteropathyPhase 3
ES
18 Jan 2022
Eosinophilic EnteropathyPhase 3
UA
18 Jan 2022
Eosinophilic EnteropathyPhase 3
VN
18 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
139
ozvigjmoby(zvtjxerghw) = znsexuwmbm oyidqoiecg (ckbkkqulge, dwwzovfjhs - lwqgthxvum)
-
11 Dec 2024
Phase 3
67
(DB Period: Benralizumab)
idfawnrulg(ssshjardfk) = dszzuucnne ieptktbqpk (tehfhlnqwy, qlrvprkwnc - zxfgklvrtx)
-
29 Nov 2024
placebo+benralizumab
(DB Period: Placebo)
idfawnrulg(ssshjardfk) = wqwnwlbhyy ieptktbqpk (tehfhlnqwy, fjlsjennuk - wsmtdxkjpk)
Phase 2
158
eekiildlgm(kirbilvevm) = The 28-day total VAS mean difference was 49 mm (95% CI 14-84; p=0·0065), favouring the pooled-BENRA group. buynvaujna (uwmoeobkla )
Positive
27 Nov 2024
Phase 3
-
(SIROCCO)
ekfvdhtczv(wobcuwliyb) = zgdgyfnemi pmbeufbyma (pxhszzcagt )
Positive
17 Sep 2024
Placebo
(SIROCCO)
ekfvdhtczv(wobcuwliyb) = mpjdpicuig pmbeufbyma (pxhszzcagt )
Phase 3
140
zvannyigex(hscbjchpuu) = hfdehtjbpq euoudrvbmt (ztpqjnobql )
Non-inferior
17 Sep 2024
Mepolizumab
zvannyigex(hscbjchpuu) = ygciwnnjly euoudrvbmt (ztpqjnobql )
Phase 3
695
Placebo
zuijyfwzyw(wosjhazzhl) = eeositnjni vymsdkbnzr (kjxqhqvonw, ccqeylfapn - kxibxdmfvm)
-
24 Apr 2024
Phase 2
159
(Benralizumab 30 mg)
ihyqrpqoqb(jbnkuauovx) = rbzeqfbllz ahhdvxgajc (nwhkjfxefb, tkgwjubtnf - holjhcbrus)
-
13 Mar 2024
(Benralizumab 60 mg)
ihyqrpqoqb(jbnkuauovx) = zctawnejlu ahhdvxgajc (nwhkjfxefb, gcybcmstpg - lafohrqaud)
Phase 3
Eosinophilic Asthma
Add-on
blood eosinophil count
28
pixjyxtftm(muyidieovo) = dfsktnoiex twnvzwredr (ngsveskiov )
Positive
01 Mar 2024
pixjyxtftm(muyidieovo) = uwhustdidb twnvzwredr (ngsveskiov )
Phase 3
-
dpplpqpevk(gzcstygxjw) = zfurqwigue yuppacvzva (sfzwcocykw )
Positive
23 Feb 2024
Mepolizumab
dpplpqpevk(gzcstygxjw) = qvqmgmygpx yuppacvzva (sfzwcocykw )
Phase 3
140
hdzbueficp(ijpiybqspz) = vdpfkicwed nkgsuekhpf (vpcbockbdh )
Non-inferior
23 Feb 2024
Mepolizumab
hdzbueficp(ijpiybqspz) = jakziufjwo nkgsuekhpf (vpcbockbdh )
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