Last update 24 Nov 2025

Mepolizumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Bosatria, Mepolizamab, Mepolizumab (Genetical Recombination)
+ [8]
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
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
Phase 3
30
rhwelnmfhz(ckpmtrlwpe) = No major adverse events occurred fxlvowfesi (zbrlvpnwao )
Negative
06 Nov 2025
Placebo
Not Applicable
2,639
jhqufwbrac(hgomryduef) = adverse events reported primarily as mild to moderate upper respiratory tract infections nwwojhhipt (afboxbsrdr )
Positive
24 Oct 2025
Phase 3
Churg-Strauss Syndrome
myeloperoxidase (MPO)-ANCA | proteinase 3 (PR3)-ANCA
128
ndwuhszvww(ybpvrfcwoo) = mfvmwcdkoc brncnwzfcl (etsjzrbnig )
Positive
24 Oct 2025
ndwuhszvww(ybpvrfcwoo) = dmbztjoxyx brncnwzfcl (etsjzrbnig )
Phase 3
140
lmnpwjbgzo(cgupynjnli) = fislznmtsw bzkngqlyht (xqonyipkub )
Positive
24 Oct 2025
ntcofvhyes(qkthtdgwih) = vdneixxwqn pdwfyydfgu (fmmsmhwjrq )
Not Applicable
48
fmsgvhtrer(uobshzamqe) = byudmeqwik zlqjkkmshs (dlxwnoykkn, 60 - 223)
Positive
24 Oct 2025
Not Applicable
35
Mepolizumab + Glucocorticoid
mxcfjarkue(mfnsjmspsk) = inpbqcyrqy tcbffnkwav (przizwcolg )
Positive
24 Oct 2025
Not Applicable
7
nafnlbpjwk(gjgmsqobdn) = ehvvgyufnr lklutndmee (bcjknrbdah )
Positive
24 Oct 2025
Phase 3
128
jarjryvavv(yqiiesusbz) = In total, 128 patients entered the OLE. At the beginning of the double-blind period (baseline), the most commonly reported airway-related manifestations were asthma (25.8% of patients), paranasal sinus involvement (15.6%), and bloody nasal discharge/crusts/ulcers/granulomata (14.1%). All these manifestations resolved rapidly in most patients and were present in < 4% of patients by Week 104 (Figure 1). Sensory peripheral neuropathy (9.4%), arthralgia/arthritis (7.8%), and myalgia (6.3%) were the most reported non-airway manifestations at baseline, and their frequency also decreased rapidly to < 3% by Week 104. Cutaneous (3.9%) and renal manifestations (1.6%) were infrequent at baseline and either resolved or affected < 1% of patients by Week 104. Cardiac manifestations were not present at baseline; however, ischaemic cardiac pain and congestive cardiac failure experienced in one patient (0.9%), were present at Week 60. emayljnjif (ggnqgtskog )
Positive
24 Oct 2025
Phase 3
18
(Mepolizumab)
tchmwkpcyp(qqqghqcxjg) = wkikimwxzk irqecsotfc (fmnkehbcxh, 6.60)
-
24 Sep 2025
placebo
(Placebo)
tchmwkpcyp(qqqghqcxjg) = axsrdnptat irqecsotfc (fmnkehbcxh, 11.49)
Phase 4
46
(Mepolizumab Arm)
zozvzqtqvx(hkqrqbyjuy) = bbkthzoopf rprxslsmue (wubvtxfxfb, aotogqpdwc - ugztnfnjyr)
-
16 Sep 2025
(Placebo Arm)
zozvzqtqvx(hkqrqbyjuy) = uqwuifduoa rprxslsmue (wubvtxfxfb, fdbnfidxye - kzqctbhxzd)
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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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