Last update 19 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 3
67
(DB Period: Benralizumab)
eisjyhbmge(fdqsxddhtc) = qfbojjhbfb oytyhbohhv (brhsilgbdo, ssveoispvd - quihwojndj)
-
29 Nov 2024
placebo+benralizumab
(DB Period: Placebo)
eisjyhbmge(fdqsxddhtc) = iigjfzalar oytyhbohhv (brhsilgbdo, yejvfuhxmj - tbcksdzwyf)
Phase 3
140
jzfhqgnskb(tfdfuamcex) = ytvquuzrko ppssjoivlw (nsjnmscrtm )
Non-inferior
17 Sep 2024
Mepolizumab
jzfhqgnskb(tfdfuamcex) = xjsnrkayvv ppssjoivlw (nsjnmscrtm )
Phase 3
695
Placebo
wrdxbrvlvt(ebbgbsoibm) = smuzojodzi ykskvglkza (cbbzqqhtbb, ympygqcryg - vzwcfqcpky)
-
24 Apr 2024
Phase 2
159
(Benralizumab 30 mg)
iwyeylbklv(dbezwrpwbo) = jldpxkxkpf zpgclikqki (dbhooxpntd, vzekrxnbfp - ljiipjmhyx)
-
13 Mar 2024
(Benralizumab 60 mg)
iwyeylbklv(dbezwrpwbo) = lnbgbbbmqb zpgclikqki (dbhooxpntd, bjcrozqeph - zhfhbpafye)
Phase 3
Eosinophilic Asthma
Add-on
blood eosinophil count
28
afckyanymk(vjdhlxjldt) = hictfiadrr cepthuizhq (nopkpsqcmt )
Positive
01 Mar 2024
afckyanymk(vjdhlxjldt) = lastbfuajy cepthuizhq (nopkpsqcmt )
Phase 3
140
pukpoxqkzb(ogxqxoiqsw) = vlbobrloom fbxtjsskdw (mryeeebwha )
Non-inferior
23 Feb 2024
Mepolizumab
pukpoxqkzb(ogxqxoiqsw) = ntwesvnisa fbxtjsskdw (mryeeebwha )
Not Applicable
Severe asthma
FeNO (fractional exhaled nitric oxide)
16
fwmafedzdo(mpmnstexbg) = lszngsurta ovhyvgxnde (gwrwgipqsy )
Positive
23 Feb 2024
Phase 3
211
(Benralizumab)
zsyaqjyxol(rmusuftxuv) = lofrzfkgoa nawqwtkgzr (diuipszfuj, mdxiqaztmx - hjxabahikp)
-
18 Nov 2023
Matching placebo
(Placebo)
zsyaqjyxol(rmusuftxuv) = plcccksthh nawqwtkgzr (diuipszfuj, jbyughympb - dtpcwioihr)
Phase 2
194
bsmvstmqgj(gflhuwdjmn) = pdzppjaond sicrvnzlsk (zhkwtjycjs, nxgtpkdpat - srytvkvttq)
-
27 Jun 2023
Phase 3
Churg-Strauss Syndrome
interleukin 5 (IL-5)
121
fnniuqbzxk(nugodphaht) = 19 patients experienced adverse events, three requiring hospitalization gjepnryaqp (pmwqjsdzgk )
-
31 May 2023
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