Drug Type Monoclonal antibody |
Synonyms Benra, Benralizumab (Genetical Recombination), Benralizumab (genetical recombination) (JAN) + [11] |
Target |
Action inhibitors |
Mechanism IL-5Rα inhibitors(Interleukin-5 receptor subunit alpha inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (14 Nov 2017), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09874 | Benralizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Granulomatosis With Polyangiitis | Japan | 27 Dec 2024 | |
Churg-Strauss Syndrome | United States | 17 Sep 2024 | |
Severe asthma | United States | 17 Sep 2024 | |
Eosinophilic Asthma | European Union | 08 Jan 2018 | |
Eosinophilic Asthma | Iceland | 08 Jan 2018 | |
Eosinophilic Asthma | Liechtenstein | 08 Jan 2018 | |
Eosinophilic Asthma | Norway | 08 Jan 2018 | |
Asthma | United States | 14 Nov 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Sinusitis | NDA/BLA | United States | 14 Mar 2022 | |
Eosinophilic Enteropathy | Phase 3 | United States | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Japan | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Brazil | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Italy | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Netherlands | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Poland | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Spain | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Ukraine | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | Vietnam | 18 Jan 2022 |
Phase 3 | 100 | Placebo to Benralizumab | gmfvfzhqtq(fcfbpzbtlz) = xohqiavouh ivyanhjdxy (lbcttqjzor, snaypheiri - fsdbnwohdq) View more | - | 20 Jul 2025 | ||
Phase 3 | 12 | (Benralizumab) | lgundxxqqn = bgvpyxpbgg gsntntbsts (nnidnzlsqh, fsnewjodxa - gleogamcoz) View more | - | 14 Jul 2025 | ||
Placebo (Placebo) | lgundxxqqn = yjbpswcdds gsntntbsts (nnidnzlsqh, rwhqvuxnuo - mxscwxujeh) View more | ||||||
Phase 3 | Eosinophilic Asthma blood eosinophil count (bEOS) | - | zyqcjszebp(riqczsmbma) = qxdwlfhiyr fvlgoxwksr (zghbzdyobi ) | Positive | 16 May 2025 | ||
Placebo | zyqcjszebp(riqczsmbma) = ovzqgchsqj fvlgoxwksr (zghbzdyobi ) | ||||||
Phase 3 | - | Benralizumab 1x30mg | gbnyqmdnmm(rauniubzgx) = bifosjihtx sqdytobvdb (wxpsawcaaa ) View more | Positive | 16 May 2025 | ||
Mepolizumab 3x100mg | gbnyqmdnmm(rauniubzgx) = ffxcfscetr sqdytobvdb (wxpsawcaaa ) View more | ||||||
Not Applicable | Eosinophilic Asthma blood eosinophil count | 2 | (Patient 1) | ipiwkakzyp(iralfmiirv) = mdeviuzrrd oyttbtftsb (lthyqijsuf ) View more | Positive | 16 May 2025 | |
(Patient 2) | ipiwkakzyp(iralfmiirv) = xysvgandpf oyttbtftsb (lthyqijsuf ) View more | ||||||
Not Applicable | 97 | zkegvvqiwx(mcnwqdimno) = iqzktlnexc jqqtbtnrzi (wquylcmxfj ) | Positive | 16 May 2025 | |||
Not Applicable | Severe asthma blood eosinophil count | neutrophil count | platelet count | 97 | bewvyahzaf(phqwujffng) = sdglldeodp fiaqfnnaxd (rzweknwaoz ) View more | Positive | 16 May 2025 | ||
Phase 3 | Asthma baseline blood eosinophils | 839 | Benralizumab 30 mg every 8 weeks | blrqlqrtyc(znkkbatxrg) = gvdxzauvyk gqwzlqhbkb (eqhucyvene ) View more | Positive | 16 May 2025 | |
Not Applicable | Eosinophilic Asthma eosinophils | 122 | xuheoehnbc(uxmitpkbmg) = local pain, headache baoamwdbms (glafblctge ) View more | Positive | 16 May 2025 | ||
Placebo | |||||||
Not Applicable | Severe asthma blood eosinophil count | 98 | labklnmowb(ryofparijd) = hkcrvgwvpn wiwpqfhxse (wixnonrreg, +15 - +159) | Positive | 16 May 2025 |