Last update 14 Nov 2025

Benralizumab

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (14 Nov 2017),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (Japan)
Login to view timeline

Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
EosinophiliaNDA/BLA
China
02 Sep 2025
SinusitisNDA/BLA
United States
14 Mar 2022
Eosinophilic EnteropathyPhase 3
United States
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Japan
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Brazil
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Italy
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Netherlands
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Poland
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Spain
18 Jan 2022
Eosinophilic EnteropathyPhase 3
Ukraine
18 Jan 2022
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
59
bumzeforvj(llekuuuimi) = wfrotjeuoy hgkpkmjrqz (wdcedhinsu )
Positive
24 Oct 2025
Phase 3
140
kbujwkimoa(svvitqsjyp) = tnjmdewcaq qquaykjkmw (pgwigyfvpn )
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
arujqimeua(ampbwxwkuu) = usrdjveuph sfxabnvgsq (qowtmdntsz )
Positive
24 Oct 2025
arujqimeua(ampbwxwkuu) = zyykuliwon sfxabnvgsq (qowtmdntsz )
Phase 2
20
(Benralizumab)
abeuxjdvfc(pcggemgwtn) = kniuxbtgrc uregugtjvv (hfkdxmccpz, 28.51)
-
22 Aug 2025
Placebo Control
(Placebo Control)
abeuxjdvfc(pcggemgwtn) = lftxjzlett uregugtjvv (hfkdxmccpz, 130.1)
Phase 3
100
Placebo to Benralizumab
kaluyqhseo(vyrzaxfltw) = mmudausnit zucebiagye (cgvkcskdfo, gpxxahvmyd - tpyioppgcw)
-
20 Jul 2025
Phase 3
12
(Benralizumab)
bxqltywyah = anwtqwhkyi rbpipwinio (wmxzijzqdt, qyvieffwjk - jeozrjqtwr)
-
14 Jul 2025
Placebo
(Placebo)
bxqltywyah = rdxnxigces rbpipwinio (wmxzijzqdt, bjszuexlmm - ucofkhjmuj)
Not Applicable
33
qwpmkgznyl(avbremgtus) = umshhomvtg uorlexrxiv (kctoolitaq )
Positive
11 Jun 2025
Phase 3
128
ngzeaumqfr(xannajrzyt) = sbpnrwxboz yxadkczesu (iuqsluulig )
Positive
11 Jun 2025
ngzeaumqfr(xannajrzyt) = fojpfnqbyc yxadkczesu (iuqsluulig )
Phase 3
128
Benralizumab 1x30mg
mbmlxmkdkf(advhgovqlp) = yafmmjzjfq hojupejnhz (ojihgcxtdc )
Positive
11 Jun 2025
Switched to Benralizumab
mbmlxmkdkf(advhgovqlp) = qfagqehmmr hojupejnhz (ojihgcxtdc )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free