Last update 03 Apr 2025

Benralizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Benra, Benralizumab (Genetical Recombination), Benralizumab (genetical recombination) (JAN)
+ [11]
Target
Action
inhibitors
Mechanism
IL-5Rα inhibitors(Interleukin-5 receptor subunit alpha inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Nov 2017),
RegulationFast Track (United States), Orphan Drug (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Granulomatosis With Polyangiitis
Japan
27 Dec 2024
Churg-Strauss Syndrome
United States
17 Sep 2024
Severe asthma
United States
17 Sep 2024
Eosinophilic Asthma
European Union
08 Jan 2018
Eosinophilic Asthma
Iceland
08 Jan 2018
Eosinophilic Asthma
Liechtenstein
08 Jan 2018
Eosinophilic Asthma
Norway
08 Jan 2018
Asthma
United States
14 Nov 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
SinusitisNDA/BLA
United States
14 Mar 2022
Eosinophilic EnteropathyPhase 3
United States
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Japan
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Brazil
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Italy
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Netherlands
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Poland
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Spain
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Ukraine
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Vietnam
18 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
140
(Benralizumab 30 mg)
ojdgahqypr = zvplgcjohu yiqyfsuila (esctjaioqn, xyilwtybww - bkgzlwuasg)
-
25 Mar 2025
(Mepolizumab 300 mg)
ojdgahqypr = ousniqmlng yiqyfsuila (esctjaioqn, ucbeughwtm - hcgqnsnius)
Phase 4
45
jhmcajpibf(yqywiuwwov) = xroglbmshb drxngehxwk (ejgoitlzlj, 0.4199)
-
25 Mar 2025
Phase 4
170
(Treatment Reduction)
spxmplcuvm = sxrulsvsmp rciewxhaqh (ivfgfqclgf, zxskapnlvn - ovsifmyudc)
-
25 Mar 2025
aaovhuicxb(sjxltzsuhx) = ovkqzndlqn tmsvvyhfbw (sobvieghtt, 0.0677)
Phase 4
139
hjuhyxspll = vblsmtkhbb vxsxivlkck (adwetfminm, yulhixtktg - xwjzgqoehc)
-
11 Dec 2024
Phase 3
67
(DB Period: Benralizumab)
jlmirekudf = qyavxmzcll gswirtpfxt (zmafbrjisf, edgszlyfuw - wsocmppmel)
-
29 Nov 2024
placebo+benralizumab
(DB Period: Placebo)
jlmirekudf = uhoouxgojc gswirtpfxt (zmafbrjisf, omlioweopn - jiapirsuvf)
Phase 2
158
khiqfzexvy(icdkfxqwws) = The 28-day total VAS mean difference was 49 mm (95% CI 14-84; p=0·0065), favouring the pooled-BENRA group. nesfpqdeiz (eqfdffmjtc )
Positive
27 Nov 2024
Phase 3
-
(SIROCCO)
ktnggstcrw(dpgyoptumv) = pqaapatzoz pkkuhvjpsz (huyqqhzizz )
Positive
17 Sep 2024
Placebo
(SIROCCO)
ktnggstcrw(dpgyoptumv) = qolgqfysko pkkuhvjpsz (huyqqhzizz )
Phase 3
140
hqgkdbqxpp(phhchdxvfb) = wlekwwwrpd nzjugdqumb (eppsendwtk )
Non-inferior
17 Sep 2024
hqgkdbqxpp(phhchdxvfb) = jwwgoygvps nzjugdqumb (eppsendwtk )
Not Applicable
-
pcketyrvpd(veybbgrnuo) = Hypereosinophilic syndrome (HES) is a rare condition defined by more than 1500 eosinophil cells/µL in peripheral blood. It can be primary to clonal hematopoiesis, secondary to cytokines related eosinophilic production or idiopathic. If left untreated it can lead to multisystem end organ damage ligghaoiug (pspkkafkwo )
-
19 May 2024
Benralizumab
Phase 3
695
Placebo
ukqibrwcio(vmjofipprl) = jyyzlicskd xozqnwylqy (gpcxsxhmfh, qeffdcqxwy - rxrdgudyly)
-
24 Apr 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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