Last update 31 May 2025

Mepolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Bosatria, Mepolizamab, Mepolizumab (Genetical Recombination)
+ [7]
Target
Action
inhibitors
Mechanism
IL-5 inhibitors(Interleukin-5 inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (04 Nov 2015),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (South Korea)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
United States
22 May 2025
Asthma
Japan
25 Mar 2020
Eosinophilic Asthma
South Korea
01 Apr 2016
Chronic rhinosinusitis with nasal polyps
European Union
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
Iceland
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
Liechtenstein
01 Dec 2015
Chronic rhinosinusitis with nasal polyps
Norway
01 Dec 2015
Churg-Strauss Syndrome
European Union
01 Dec 2015
Churg-Strauss Syndrome
Iceland
01 Dec 2015
Churg-Strauss Syndrome
Liechtenstein
01 Dec 2015
Churg-Strauss Syndrome
Norway
01 Dec 2015
Hypereosinophilic Syndrome
European Union
01 Dec 2015
Hypereosinophilic Syndrome
Iceland
01 Dec 2015
Hypereosinophilic Syndrome
Liechtenstein
01 Dec 2015
Hypereosinophilic Syndrome
Norway
01 Dec 2015
Pulmonary Eosinophilia
European Union
01 Dec 2015
Pulmonary Eosinophilia
Iceland
01 Dec 2015
Pulmonary Eosinophilia
Liechtenstein
01 Dec 2015
Pulmonary Eosinophilia
Norway
01 Dec 2015
Severe asthma
United States
04 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Asthma, Nasal Polyps, and Aspirin IntolerancePhase 3
China
22 Apr 2021
Asthma, Nasal Polyps, and Aspirin IntolerancePhase 3
Japan
22 Apr 2021
Asthma, Nasal Polyps, and Aspirin IntolerancePhase 3
Russia
22 Apr 2021
EosinophiliaPhase 3
United Kingdom
07 Sep 2020
Nasal PolypsPhase 3
United States
25 May 2017
Nasal PolypsPhase 3
Argentina
25 May 2017
Nasal PolypsPhase 3
Australia
25 May 2017
Nasal PolypsPhase 3
Canada
25 May 2017
Nasal PolypsPhase 3
Germany
25 May 2017
Nasal PolypsPhase 3
Netherlands
25 May 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Galectin-10 (Gal10) | TARC | peripheral blood eosinophil counts
78
kgwsakqmkj(mkahsxhnja) = ozihukqvev zvorswlvgy (ltbcbyxnip )
Positive
16 May 2025
Phase 4
Refractory chronic cough
sputum eosinophilia
30
ideelojjxt(gabdelsezn): % = 18.6 (95% CI, -23 to 82), P-Value = 0.44
Negative
16 May 2025
Placebo
Not Applicable
Severe asthma
eosinophilic phenotype
174
wtdhrfepbb(cbrcgdlwoh): incident rate ratio = 0.26 (95% CI, 0.18 - 0.36)
Positive
16 May 2025
Previous Biologic Treatments
Not Applicable
308
hfevnztedn(rfezdijtpm) = lhzdsanppb vhypavynul (cmdbvobhjc )
Positive
16 May 2025
Not Applicable
Severe asthma
eosinophilic phenotype
306
evoutggstk(mqwnphhbhd) = gvroumqvsp oieungvqin (qjtdssjvhc )
Positive
16 May 2025
Maintenance OCS (mOCS)
evoutggstk(mqwnphhbhd) = gzoplxaifj oieungvqin (qjtdssjvhc )
Phase 4
100
rmaxyugdxj = ojnjlpkyup tzhyvdyazu (qcusdypoer, ygowmtmcjt - rzanqyppvn)
-
10 Dec 2024
Phase 3
169
(Mepolizumab)
wprflefdmr(tmofzzfkps) = hxnwksrkwb zrlvhvcipu (aleofqexin, 0.164)
-
25 Nov 2024
placebo
(Placebo)
wprflefdmr(tmofzzfkps) = tygsfqmxxa zrlvhvcipu (aleofqexin, 0.164)
Phase 3
514
Mepolizumab 100 mg SC
(Adults/adolescents (≥12 years of age))
oyzudertpp(flmowkesxe) = upplmfabxk kpcwdftjnu (feowhcifnk )
Positive
28 Oct 2024
Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively)
(Pediatric patients (6-11 years of age))
-
Not Applicable
1
Mepoluzimab 100 mg every 4 weeks
neodawlwap(kqnhwrrymf) = svulgqwzyo hpapjbiirb (dwwubsounz )
Positive
24 Oct 2024
Not Applicable
-
Mepolizumab
vxwthsfaul(aoaqujnirp) = lyjvqwqkxx drfhvuhasy (ohsqlildxw )
-
24 Oct 2024
vxwthsfaul(aoaqujnirp) = dilcbjvfyj drfhvuhasy (ohsqlildxw )
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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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