Drug Type Monoclonal antibody |
Synonyms Benra, Benralizumab (Genetical Recombination), Benralizumab (genetical recombination) (JAN) + [10] |
Target |
Mechanism IL-5Rα inhibitors(Interleukin-5 receptor subunit alpha inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (14 Nov 2017), |
RegulationFast Track (US), Orphan Drug (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D09874 | Benralizumab |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Churg-Strauss Syndrome | US | 17 Sep 2024 | |
Severe asthma | US | 17 Sep 2024 | |
Eosinophilic Asthma | EU | 08 Jan 2018 | |
Eosinophilic Asthma | IS | 08 Jan 2018 | |
Eosinophilic Asthma | LI | 08 Jan 2018 | |
Eosinophilic Asthma | NO | 08 Jan 2018 | |
Asthma | US | 14 Nov 2017 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Sinusitis | NDA/BLA | US | 14 Mar 2022 | |
Eosinophilic Enteropathy | Phase 3 | US | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | JP | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | BR | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | IT | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | NL | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | PL | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | ES | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | UA | 18 Jan 2022 | |
Eosinophilic Enteropathy | Phase 3 | VN | 18 Jan 2022 |
Phase 3 | 67 | (DB Period: Benralizumab) | eisjyhbmge(fdqsxddhtc) = qfbojjhbfb oytyhbohhv (brhsilgbdo, ssveoispvd - quihwojndj) View more | - | 29 Nov 2024 | ||
placebo+benralizumab (DB Period: Placebo) | eisjyhbmge(fdqsxddhtc) = iigjfzalar oytyhbohhv (brhsilgbdo, yejvfuhxmj - tbcksdzwyf) View more | ||||||
Phase 3 | 140 | jzfhqgnskb(tfdfuamcex) = ytvquuzrko ppssjoivlw (nsjnmscrtm ) View more | Non-inferior | 17 Sep 2024 | |||
Mepolizumab | jzfhqgnskb(tfdfuamcex) = xjsnrkayvv ppssjoivlw (nsjnmscrtm ) View more | ||||||
Phase 3 | 695 | Placebo | wrdxbrvlvt(ebbgbsoibm) = smuzojodzi ykskvglkza (cbbzqqhtbb, ympygqcryg - vzwcfqcpky) View more | - | 24 Apr 2024 | ||
Phase 2 | 159 | (Benralizumab 30 mg) | iwyeylbklv(dbezwrpwbo) = jldpxkxkpf zpgclikqki (dbhooxpntd, vzekrxnbfp - ljiipjmhyx) View more | - | 13 Mar 2024 | ||
(Benralizumab 60 mg) | iwyeylbklv(dbezwrpwbo) = lnbgbbbmqb zpgclikqki (dbhooxpntd, bjcrozqeph - zhfhbpafye) View more | ||||||
Phase 3 | 28 | afckyanymk(vjdhlxjldt) = hictfiadrr cepthuizhq (nopkpsqcmt ) View more | Positive | 01 Mar 2024 | |||
afckyanymk(vjdhlxjldt) = lastbfuajy cepthuizhq (nopkpsqcmt ) View more | |||||||
Phase 3 | 140 | pukpoxqkzb(ogxqxoiqsw) = vlbobrloom fbxtjsskdw (mryeeebwha ) View more | Non-inferior | 23 Feb 2024 | |||
Mepolizumab | pukpoxqkzb(ogxqxoiqsw) = ntwesvnisa fbxtjsskdw (mryeeebwha ) View more | ||||||
Not Applicable | Severe asthma FeNO (fractional exhaled nitric oxide) | 16 | fwmafedzdo(mpmnstexbg) = lszngsurta ovhyvgxnde (gwrwgipqsy ) View more | Positive | 23 Feb 2024 | ||
Phase 3 | 211 | (Benralizumab) | zsyaqjyxol(rmusuftxuv) = lofrzfkgoa nawqwtkgzr (diuipszfuj, mdxiqaztmx - hjxabahikp) View more | - | 18 Nov 2023 | ||
Matching placebo (Placebo) | zsyaqjyxol(rmusuftxuv) = plcccksthh nawqwtkgzr (diuipszfuj, jbyughympb - dtpcwioihr) View more | ||||||
Phase 2 | 194 | bsmvstmqgj(gflhuwdjmn) = pdzppjaond sicrvnzlsk (zhkwtjycjs, nxgtpkdpat - srytvkvttq) View more | - | 27 Jun 2023 | |||
Phase 3 | Churg-Strauss Syndrome interleukin 5 (IL-5) | 121 | fnniuqbzxk(nugodphaht) = 19 patients experienced adverse events, three requiring hospitalization gjepnryaqp (pmwqjsdzgk ) | - | 31 May 2023 |