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Drug

Benralizumab

Approved medicine
ClassInterleukin-5 receptor subunit alpha inhibitorResearchOngoing clinical research

Also known as Fasenra.

RxNorm1989100ChEMBLCHEMBL1742991ATCR03DX10UNII71492GE1FX
10
Active clinical trials
IL5RA
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics

Clinical trial2026-08-25Results expected Q4 2026 · ClinicalTrials.gov

STEP: A Prospective, Interventional, Multicenter, Single-Arm Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Clinical trial2026-08-13Status changed to Completed · ClinicalTrials.gov

A Randomised, Double-blind, Active-controlled 52-week Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy (MANDARA Study)

Clinical trial2026-08-12Results posted · ClinicalTrials.gov

A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-Week Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

Clinical trial2026-07-10Results posted · ClinicalTrials.gov

Fasenra Demonstrates Durability Over the Full 8-week Treatment Period

Clinical trial2026-07-07Results expected Q3 2027 · ClinicalTrials.gov

Phase 3, Open-label Trial to Evaluate Safety, Pharmacokinetics, and Efficacy of Benralizumab in Children With Eosinophilic Diseases (CLIPS)

Clinical trial2026-06-30Results expected Q1 2028 · ClinicalTrials.gov

Efficacy and Safety of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma (DOMINICA)

Clinical trial2026-06-01Results expected Q2 2030 · ClinicalTrials.gov

Phase II Study of IL-5-receptor-alpha-chain (IL-5Rα) Inhibition With Benralizumab for Eosinophil-Related Cutaneous Adverse Events in Cancer Patients

Clinical trial2026-06-01Results posted · ClinicalTrials.gov

A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

Clinical trial2026-05-18Results posted · ClinicalTrials.gov

ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment

Clinical trial2026-04-08Results expected Q4 2029 · ClinicalTrials.gov

Benralizumab Regulates Atopic Dermatitis Through Effects on Eosinophils, Basophils and Innate Lymphoid Type 2 Cells.

Clinical trial2025-08-22Results posted · ClinicalTrials.gov

Approval: Fasenra (EMA)

Regulatory2018-01-08EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Benralizumab
Aliases & brands
Fasenra
RxNorm CUI
1989100
ChEMBL ID
CHEMBL1742991
ATC codes
R03DX10
UNII
71492GE1FX
Primary mechanism
Interleukin-5 receptor subunit alpha inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-5 receptor subunit alpha
IL5RA · Q01344
INHIBITORInterleukin-5 receptor subunit alpha inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2018-01-08
Latest approval
2018-01-08
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-01-08Approval
Approval: Fasenra (EMA)
Indication: AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids… Show full indication

AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists (see section 5.1).Eosinophilic granulomatosis with polyangiitis (EGPA)Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (see section 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

58 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
58
registered trials across all phases
LATEST COMPLETION 2026
10
Active studies
5
Recruiting
42
Late-stage (III+)
34
Completed
14
Discontinued
PHASE DISTRIBUTIONn = 58
Phase 12Phase 214Phase 2 / 32Phase 332Phase 47Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

RecruitingPH IVUniversity of California, San Diegon=1202028

Fasenra Demonstrates Durability Over the Full 8-week Treatment Period

Not yet recruitingPH IVEndeavor Healthn=402028

A Phase 4, Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Benralizumab on Structural and Lung Function Changes in Severe Eosinophilic Asthmatics

Active, not recruitingPH IVAstraZenecan=752026

Asthma Exacerbation Profile in Patients on Open Label Treatment With Benralizumab for Severe Eosinophilic Asthma - an Exploratory Cohort Study

CompletedPH IVNHS Greater Glasgow and Clyden=1572024

A Postmarketing, Phase 4, Multicentre, Prospective, Single-arm Study to Assess the Safety of Fasenra® (Benralizumab) in Adult Patients of Severe Asthma With Eosinophilic Phenotype in India.

CompletedPH IVAstraZenecan=1392023

Recent completions

Trials that read out recently, adding to the completed evidence base.

STEP: A Prospective, Interventional, Multicenter, Single-Arm Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

CompletedPH IIIAstraZenecan=5042026

Phase II Study of IL-5-receptor-alpha-chain (IL-5Rα) Inhibition With Benralizumab for Eosinophil-Related Cutaneous Adverse Events in Cancer Patients

CompletedPH IIMemorial Sloan Kettering Cancer Centern=512026

A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

CompletedPH IIIKey trialGlaxoSmithKlinen=1,7172025

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

CompletedPH IIIAstraZenecan=6892025

NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab

CompletedPH IIIHumanitas Clinical and Research Centern=142024

Asthma Exacerbation Profile in Patients on Open Label Treatment With Benralizumab for Severe Eosinophilic Asthma - an Exploratory Cohort Study

CompletedPH IVNHS Greater Glasgow and Clyden=1572024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.