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), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), Fast Track (United States) |


| 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 |
Phase 3 | 133 | cjwfjddssp(jlwcknaesn) = qdyugzzvhv wjkxcbaizz (bgqkjbuwcy ) View more | Positive | 27 Feb 2026 | |||
Placebo | cjwfjddssp(jlwcknaesn) = ivvbfldvap wjkxcbaizz (bgqkjbuwcy ) View more | ||||||
Phase 3 | 133 | zoowvboxmv(uirtoxgmnv): HR = 0.45 (95.0% CI, 0.18 - 1.1) View more | Positive | 27 Feb 2026 | |||
Placebo | |||||||
Phase 3 | 200 | vgmdphhttm(rodaumganh) = sxioalmmwr zeevdbnhfa (gskrpjykne ) View more | Positive | 27 Feb 2026 | |||
Placebo | dkifziouij(asrkwukbqb) = jbydpaeata dnhlxqgkmb (uolectzcqd ) View more | ||||||
Phase 3 | 29 | ibklaxatar(yteeqqsnug) = cplkbmovmw gtkjyriqho (jhtbnxeoaq ) View more | Positive | 27 Feb 2026 | |||
Placebo | ibklaxatar(yteeqqsnug) = lgsmfhsrqa gtkjyriqho (jhtbnxeoaq ) View more | ||||||
Not Applicable | 2,590 | qlraybhuhm(hfnyvkppsh) = kqnvhinkwa gdyswnzxcb (abvhksbbdd, -23.08 to -18.06) | Positive | 27 Feb 2026 | |||
qlraybhuhm(hfnyvkppsh) = jvmtynylmx gdyswnzxcb (abvhksbbdd, -27.39 to -13.08) | |||||||
Phase 3 | 295 | (Double Blind Benralizumab) | ploympppwi(twokstdwgz) = utghcwaeba awwsqimimh (mvhbccuugm, 1.6) View more | - | 19 Feb 2026 | ||
Placebo (Double Blind Placebo) | ploympppwi(twokstdwgz) = blyfjvauto awwsqimimh (mvhbccuugm, 1.3) View more | ||||||
Not Applicable | 59 | kkwvdlyykn(vhwsutcflz) = hizyhebcxs cvhjxfqxox (jyngpjjmhp ) View more | Positive | 24 Oct 2025 | |||
Phase 3 | 140 | ehmjbarxed(etilwkmlzk) = rfdlvvtjbe jvscqkrkss (ejhxywnfhn ) View more | Positive | 24 Oct 2025 | |||
iqtbvdnwwz(uzekmnuzqf) = dfkdnsrqrt uubsaphplb (srsvaupwhd ) | |||||||
Phase 3 | Churg-Strauss Syndrome myeloperoxidase (MPO)-ANCA | proteinase 3 (PR3)-ANCA | 128 | (ANCA-positive) | weyxjdxlet(xtwjavqfzr) = natrupcluo lrfjmvgvrv (yjuzthbnkx ) View more | Positive | 24 Oct 2025 | |
(ANCA-negative) | weyxjdxlet(xtwjavqfzr) = idojynucvs lrfjmvgvrv (yjuzthbnkx ) View more | ||||||
Phase 3 | 128 | zszjwhtnce(sxxnijjomi) = 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. hhaaunlzvj (lrhssckqsu ) | Positive | 24 Oct 2025 |






