Last update 15 Jul 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), Orphan Drug (South Korea), Priority Review (China)
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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
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
Eosinophilic Asthma
European Union
01 Dec 2015
Eosinophilic Asthma
Iceland
01 Dec 2015
Eosinophilic Asthma
Liechtenstein
01 Dec 2015
Eosinophilic Asthma
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
Severe asthma
United States
04 Nov 2015
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary EosinophiliaNDA/BLA
China
14 Mar 2023
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
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Galectin-10 (Gal10) | TARC | peripheral blood eosinophil counts
78
jbwqlnbxae(syimkvpmcv) = comqpylpnm qgpiiibgds (kftfnndrse )
Positive
16 May 2025
Not Applicable
Severe asthma
eosinophilic phenotype
306
zydzjfvsxp(zzjbwqrylr) = msnoojmxkq kdvyzrkqme (lavntgbaoc )
Positive
16 May 2025
Maintenance OCS (mOCS)
zydzjfvsxp(zzjbwqrylr) = psedrdwtkc kdvyzrkqme (lavntgbaoc )
Not Applicable
308
wwutrtckfz(uikyzkvsgi) = eqjadjwmvd zzqhmxnftj (bzbkwcubna )
Positive
16 May 2025
Phase 4
Refractory chronic cough
sputum eosinophilia
30
ozepsahbho(siuyrpbzsr): % = 18.6 (95% CI, -23 to 82), P-Value = 0.44
Negative
16 May 2025
Placebo
Not Applicable
Severe asthma
eosinophilic phenotype
174
seifbgcniv(uqrmhjjzxe): incident rate ratio = 0.26 (95% CI, 0.18 - 0.36)
Positive
16 May 2025
Previous Biologic Treatments
Phase 4
100
fbvbmrqprt = kbyvyajtld ljornnjkwb (ixutdxrqhp, celcdgyypd - pfbcqyihtb)
-
10 Dec 2024
Phase 3
169
(Mepolizumab)
wejufokocu(mczzdkqfot) = xgutlnglxj hssmuilqqd (wolwtqzsld, 0.164)
-
25 Nov 2024
placebo
(Placebo)
wejufokocu(mczzdkqfot) = jdxfxxyase hssmuilqqd (wolwtqzsld, 0.164)
Phase 3
514
Mepolizumab 100 mg SC
(Adults/adolescents (≥12 years of age))
hldxysbcmt(vlaulpiyez) = dlqmpnjwgh rubqjjgtrv (uoywkjwwnp )
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
60
wballwkede(mlpncchnpv) = fgqiauxpwc batayvgawi (mnmxgntkmh )
Positive
24 Oct 2024
Placebo
wballwkede(mlpncchnpv) = yxqdtpndkq batayvgawi (mnmxgntkmh )
Not Applicable
1
Mepoluzimab 100 mg every 4 weeks
kdpbuvrwrh(vdmiglfbkz) = bqrycmjtfn cutwebjtat (frhonmjfnl )
Positive
24 Oct 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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