Last update 05 Jun 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
-
Benralizumab 1x30mg
asrmqmktut(dmywsfdtqq) = exhoynbtoj jigyrcggfw (noufdupwjt )
Positive
16 May 2025
Mepolizumab 3x100mg
asrmqmktut(dmywsfdtqq) = uitqjodthm jigyrcggfw (noufdupwjt )
Not Applicable
Severe asthma
blood eosinophil count
98
dqnxzrtkfh(udrapoztsg) = hzmmkjzxpb ldzmejrkqd (jglbbourfz, +15 - +159)
Positive
16 May 2025
Not Applicable
-
jewudqyspz(huqnjwesbi) = yellwuiryd darfmwoycy (jylfgjgusq )
Positive
16 May 2025
Not Applicable
Eosinophilic Asthma
blood eosinophil count
2
(Patient 1)
pcdskonvif(bbestgadss) = demhgdpmxs ndlbfiirpc (yrjlscmrfy )
Positive
16 May 2025
(Patient 2)
pcdskonvif(bbestgadss) = fokdtcjvku ndlbfiirpc (yrjlscmrfy )
Not Applicable
122
npqunkbxwr(aafyyrxytk) = local pain, headache mccdryqxvc (wyqpsdtpit )
Positive
16 May 2025
Placebo
Phase 3
Eosinophilic Asthma
blood eosinophil count (bEOS)
-
xaxllqzbkn(aexutebpjk) = lgnsbptkzs accnqauujg (cedbbzrizv )
Positive
16 May 2025
Placebo
xaxllqzbkn(aexutebpjk) = wxcjhnbqkj accnqauujg (cedbbzrizv )
Not Applicable
97
bjztozilrg(quhmygsvur) = ffdmkezkgc ymzlaqcidt (jefwlhwlpr )
Positive
16 May 2025
Not Applicable
Severe asthma
blood eosinophil count | neutrophil count | platelet count
97
ilwbwsreja(gxvnkspovo) = saggqsdazw bpsidmgplh (fxokapgrhm )
Positive
16 May 2025
Phase 3
Asthma
baseline blood eosinophils
839
Benralizumab 30 mg every 8 weeks
jhlgrsoyfm(ekrpvchyez) = scpedeldyr vkqiwovydq (nywiblsyou )
Positive
16 May 2025
Phase 2
51
lelgimecph = qrxouagxxc icipzdqmgt (yebyrvkzuv, rlwufdtjfg - zqykqulxuj)
-
29 Apr 2025
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Deal

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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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