Drug Type Monoclonal antibody |
Synonyms Bosatria, Mepolizamab, Mepolizumab (Genetical Recombination) + [7] |
Target |
Action inhibitors |
Mechanism IL-5 inhibitors(Interleukin-5 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active 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) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D04923 | Mepolizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pulmonary Eosinophilia | NDA/BLA | China | 14 Mar 2023 | |
Asthma, Nasal Polyps, and Aspirin Intolerance | Phase 3 | China | 22 Apr 2021 | |
Asthma, Nasal Polyps, and Aspirin Intolerance | Phase 3 | Japan | 22 Apr 2021 | |
Asthma, Nasal Polyps, and Aspirin Intolerance | Phase 3 | Russia | 22 Apr 2021 | |
Eosinophilia | Phase 3 | United Kingdom | 07 Sep 2020 | |
Nasal Polyps | Phase 3 | United States | 25 May 2017 | |
Nasal Polyps | Phase 3 | Argentina | 25 May 2017 | |
Nasal Polyps | Phase 3 | Australia | 25 May 2017 | |
Nasal Polyps | Phase 3 | Canada | 25 May 2017 | |
Nasal Polyps | Phase 3 | Germany | 25 May 2017 |
Not Applicable | Galectin-10 (Gal10) | TARC | peripheral blood eosinophil counts | 78 | jbwqlnbxae(syimkvpmcv) = comqpylpnm qgpiiibgds (kftfnndrse ) View more | Positive | 16 May 2025 | ||
Not Applicable | Severe asthma eosinophilic phenotype | 306 | zydzjfvsxp(zzjbwqrylr) = msnoojmxkq kdvyzrkqme (lavntgbaoc ) View more | Positive | 16 May 2025 | ||
Maintenance OCS (mOCS) | zydzjfvsxp(zzjbwqrylr) = psedrdwtkc kdvyzrkqme (lavntgbaoc ) View more | ||||||
Not Applicable | 308 | wwutrtckfz(uikyzkvsgi) = eqjadjwmvd zzqhmxnftj (bzbkwcubna ) View more | 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) View more | - | 10 Dec 2024 | |||
Phase 3 | 169 | (Mepolizumab) | wejufokocu(mczzdkqfot) = xgutlnglxj hssmuilqqd (wolwtqzsld, 0.164) View more | - | 25 Nov 2024 | ||
placebo (Placebo) | wejufokocu(mczzdkqfot) = jdxfxxyase hssmuilqqd (wolwtqzsld, 0.164) View more | ||||||
NCT00244686 (Pubmed) Manual | 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 | Churg-Strauss Syndrome ANCA-negative | 1 | Mepoluzimab 100 mg every 4 weeks | kdpbuvrwrh(vdmiglfbkz) = bqrycmjtfn cutwebjtat (frhonmjfnl ) | Positive | 24 Oct 2024 |