Benralizumab

Summary

Benralizumab (CHEMBL1742991) is an approved antibody (ATC R03DX10) targeting IL5RA; indicated across 14 conditions including obstructive lung disease and asthma.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: R03DX10
• Targets: 1 (IL5RA)
• Indications: 14 conditions
• Clinical trials: 71

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1742991
Name	Benralizumab
Type	Antibody
Max phase	4
ATC	R03DX10

Also known as: Benralizumab, BIW-8405, Fasenra, MEDI-563, BENRALIZUMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
IL5RA	Interleukin 5 receptor, α subunit	Binding	8.67	0%	Q01344

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

Aggregated over 1 target gene(s): IL5RA.

Top Reactome pathways

3 total, by targets touching each:

Pathway	Targets	Genes
Interleukin-3, Interleukin-5 and GM-CSF signaling	1	IL5RA
RAF/MAP kinase cascade	1	IL5RA
Interleukin receptor SHC signaling	1	IL5RA

Dominant GO biological processes

GO term	Targets
inflammatory response to antigenic stimulus	1
signal transduction	1
positive regulation of cell population proliferation	1
cytokine-mediated signaling pathway	1
regulation of interleukin-5 production	1
interleukin-5-mediated signaling pathway	1
positive regulation of leukocyte proliferation	1
cell surface receptor signaling pathway	1
eosinophil differentiation	1

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
obstructive lung disease	4	MONDO:0002267	HP:0006536
asthma	4	MONDO:0004979	MONDO:0004979

11 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
chronic obstructive pulmonary disease	3	MONDO:0005002	EFO:0000341
hypereosinophilic syndrome	3	MONDO:0015691	EFO:1001467
nasal cavity polyp	3	MONDO:0006314	EFO:1000391
eosinophilic esophagitis	3	MONDO:0005361	EFO:0004232
bullous pemphigoid	3	MONDO:0019082	EFO:0007187
eosinophilic granulomatosis with polyangiitis	3	MONDO:0015943	EFO:0007208
sinusitis	2	MONDO:0005961	EFO:0007486
hematologic disorder	2	MONDO:0005570	HP:0001871
atopic eczema	2	MONDO:0004980	EFO:0000274
prurigo	2	MONDO:0021739	MONDO:0021739
breast neoplasm	2	MONDO:0021100	MONDO:0007254

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 71.

Phase distribution

Phase	Trials
PHASE3	33
PHASE2	16
PHASE4	8
Not specified	8
PHASE1	4
PHASE2/PHASE3	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03953300	PHASE4	ACTIVE_NOT_RECRUITING	Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
NCT06288516	PHASE4	RECRUITING	BenRalizumab Effect on Airway Remodeling in Severe asTHma
NCT06385236	PHASE4	RECRUITING	Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
NCT03183024	PHASE4	COMPLETED	Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody
NCT03652376	PHASE4	UNKNOWN	Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
NCT04102800	PHASE4	COMPLETED	Benralizumab Exacerbation Study
NCT05384938	PHASE4	COMPLETED	FAsenra Safety Trial in India
NCT05552508	PHASE4	COMPLETED	BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
NCT04157348	PHASE3	ACTIVE_NOT_RECRUITING	Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
NCT04191304	PHASE3	ACTIVE_NOT_RECRUITING	A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)
NCT05692180	PHASE3	RECRUITING	A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)
NCT06465485	PHASE3	ACTIVE_NOT_RECRUITING	STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
NCT06512883	PHASE3	RECRUITING	A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
NCT06750289	PHASE3	RECRUITING	Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment
NCT07444567	PHASE3	NOT_YET_RECRUITING	Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
NCT01914757	PHASE3	COMPLETED	Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist
NCT01928771	PHASE3	COMPLETED	Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT01947946	PHASE3	TERMINATED	Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
NCT02075255	PHASE3	COMPLETED	Efficacy and Safety Study of Benralizumab to Reduce OCS Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus LABA and Chronic OCS Therapy
NCT02130882	PHASE2/PHASE3	UNKNOWN	Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome
NCT02258542	PHASE3	COMPLETED	A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
NCT02322775	PHASE3	COMPLETED	Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
NCT02417961	PHASE3	COMPLETED	Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home
NCT02808819	PHASE3	COMPLETED	A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
NCT02814643	PHASE3	COMPLETED	Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
NCT02821416	PHASE3	COMPLETED	Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics
NCT02869438	PHASE3	COMPLETED	A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
NCT02918071	PHASE3	COMPLETED	Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home
NCT03170271	PHASE3	COMPLETED	A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.
NCT03186209	PHASE3	COMPLETED	Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
NCT03327701	PHASE3	UNKNOWN	The Effect of Benralizumab on Exercise-induced Bronchoconstriction
NCT03470311	PHASE3	COMPLETED	Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies
NCT03473977	PHASE2/PHASE3	COMPLETED	Benralizumab for Eosinophilic Gastritis (BEGS)
NCT03557307	PHASE3	COMPLETED	Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
NCT04053634	PHASE3	COMPLETED	Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
NCT04157335	PHASE3	TERMINATED	Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
NCT04185012	PHASE3	COMPLETED	NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab
NCT04305405	PHASE3	COMPLETED	PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
NCT04543409	PHASE3	TERMINATED	A Study of Benralizumab in Patients With Eosinophilic Esophagitis
NCT04612790	PHASE3	TERMINATED	A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
NCT04718389	PHASE3	COMPLETED	A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
NCT05006573	PHASE3	TERMINATED	Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis
NCT05251909	PHASE3	TERMINATED	Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study)
NCT03010436	PHASE2	ACTIVE_NOT_RECRUITING	Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study
NCT04552288	PHASE2	ACTIVE_NOT_RECRUITING	Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies
NCT06734884	PHASE2	NOT_YET_RECRUITING	Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
NCT00768079	PHASE2	COMPLETED	A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563).
NCT00783289	PHASE2	COMPLETED	A Phase 2a Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Adults With Asthma
NCT01227278	PHASE2	COMPLETED	A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01238861	PHASE2	COMPLETED	Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
NCT02772419	PHASE2	COMPLETED	Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
NCT03450083	PHASE2	COMPLETED	Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis
NCT03563066	PHASE2	COMPLETED	Effect of Benralizumab in Atopic Dermatitis
NCT04098718	PHASE2	UNKNOWN	Acute Exacerbations Treated With BenRAlizumab (The ABRA Study)
NCT04605094	PHASE2	TERMINATED	Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis
NCT04612725	PHASE2	TERMINATED	A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)
NCT04617171	PHASE2	UNKNOWN	Benralizumab Initiated During Severe Asthma Attack
NCT05273359	PHASE2	UNKNOWN	Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)
NCT05966584	PHASE2	TERMINATED	A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
NCT00512486	PHASE1	COMPLETED	A Sequential Dose-Escalation Study in Subjects With Mild Asthma
NCT00659659	PHASE1	COMPLETED	A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
NCT02968914	PHASE1	COMPLETED	Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers
NCT03928262	PHASE1	COMPLETED	Pharmacokinetic Study of Benralizumab in Healthy Chinese Subjects
NCT03733535	Not specified	ACTIVE_NOT_RECRUITING	Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI
NCT06862206	Not specified	RECRUITING	This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
NCT07214753	Not specified	RECRUITING	A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
NCT07530770	Not specified	RECRUITING	Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary Aspergillosis
NCT04665141	Not specified	UNKNOWN	Similarities and Differences of Biological Therapies for Severe Asthma.
NCT04742504	Not specified	COMPLETED	Interaction Between Benralizumab and Basophils in Eosinophilic Asthma
NCT05847452	Not specified	UNKNOWN	Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)
NCT05932849	Not specified	COMPLETED	Benralizumab Patient Access Programme Study: Retrospective Study in UK Severe Asthma Centres

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).