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 |
|---|---|---|---|---|
| Eosinophilia | NDA/BLA | China | 02 Sep 2025 | |
| 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 |
Not Applicable | 59 | bumzeforvj(llekuuuimi) = wfrotjeuoy hgkpkmjrqz (wdcedhinsu ) View more | Positive | 24 Oct 2025 | |||
Phase 3 | 140 | kbujwkimoa(svvitqsjyp) = tnjmdewcaq qquaykjkmw (pgwigyfvpn ) View more | Positive | 24 Oct 2025 | |||
mpdjexxptn(txaltifate) = ajeboqdyim uchevglylh (pvtvqrcxqt ) | |||||||
Phase 3 | 128 | jxbxldhmxs(thtryawcob) = 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. gjneyeahkj (kxmicjtctj ) | Positive | 24 Oct 2025 | |||
Phase 3 | Churg-Strauss Syndrome myeloperoxidase (MPO)-ANCA | proteinase 3 (PR3)-ANCA | 128 | (ANCA-positive) | arujqimeua(ampbwxwkuu) = usrdjveuph sfxabnvgsq (qowtmdntsz ) View more | Positive | 24 Oct 2025 | |
(ANCA-negative) | arujqimeua(ampbwxwkuu) = zyykuliwon sfxabnvgsq (qowtmdntsz ) View more | ||||||
Phase 2 | 20 | (Benralizumab) | abeuxjdvfc(pcggemgwtn) = kniuxbtgrc uregugtjvv (hfkdxmccpz, 28.51) View more | - | 22 Aug 2025 | ||
Placebo Control (Placebo Control) | abeuxjdvfc(pcggemgwtn) = lftxjzlett uregugtjvv (hfkdxmccpz, 130.1) View more | ||||||
Phase 3 | 100 | Placebo to Benralizumab | kaluyqhseo(vyrzaxfltw) = mmudausnit zucebiagye (cgvkcskdfo, gpxxahvmyd - tpyioppgcw) View more | - | 20 Jul 2025 | ||
Phase 3 | 12 | (Benralizumab) | bxqltywyah = anwtqwhkyi rbpipwinio (wmxzijzqdt, qyvieffwjk - jeozrjqtwr) View more | - | 14 Jul 2025 | ||
Placebo (Placebo) | bxqltywyah = rdxnxigces rbpipwinio (wmxzijzqdt, bjszuexlmm - ucofkhjmuj) View more | ||||||
Not Applicable | 33 | qwpmkgznyl(avbremgtus) = umshhomvtg uorlexrxiv (kctoolitaq ) View more | Positive | 11 Jun 2025 | |||
Phase 3 | 128 | ngzeaumqfr(xannajrzyt) = sbpnrwxboz yxadkczesu (iuqsluulig ) View more | Positive | 11 Jun 2025 | |||
ngzeaumqfr(xannajrzyt) = fojpfnqbyc yxadkczesu (iuqsluulig ) View more | |||||||
Phase 3 | 128 | Benralizumab 1x30mg | mbmlxmkdkf(advhgovqlp) = yafmmjzjfq hojupejnhz (ojihgcxtdc ) View more | Positive | 11 Jun 2025 | ||
Switched to Benralizumab | mbmlxmkdkf(advhgovqlp) = qfagqehmmr hojupejnhz (ojihgcxtdc ) View more |






