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Benralizumab (Medi-563)
Benralizumab is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils and basophils, leading to their depletion and reduction of eosinophilic inflammation.
Benralizumab is a monoclonal antibody that binds to the IL-5 receptor alpha on eosinophils and basophils, leading to their depletion and reduction of eosinophilic inflammation. Used for Moderate-to-severe eosinophilic asthma, Severe eosinophilic granulomatosis with polyangiitis (EGPA).
At a glance
| Generic name | Benralizumab (Medi-563) |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | IL-5 receptor antagonist monoclonal antibody |
| Target | IL-5 receptor alpha (CD125) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Respiratory |
| Phase | Phase 3 |
Mechanism of action
Benralizumab targets the IL-5 receptor alpha (CD125) expressed on eosinophils and basophils, blocking IL-5 signaling and triggering antibody-dependent cell-mediated cytotoxicity (ADCC) to eliminate these cells. This mechanism reduces eosinophilic inflammation in the airways and tissues, making it effective for eosinophil-driven inflammatory diseases. By directly targeting the IL-5 receptor rather than IL-5 itself, benralizumab achieves rapid and sustained eosinophil depletion.
Approved indications
- Moderate-to-severe eosinophilic asthma
- Severe eosinophilic granulomatosis with polyangiitis (EGPA)
Common side effects
- Headache
- Nasopharyngitis
- Upper respiratory tract infection
- Injection site reactions
- Worsening asthma
Key clinical trials
- A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases (PHASE3)
- This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
- 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 (PHASE3)
- Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics (PHASE4)
- Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
- A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
- 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) (PHASE3)
- Fasenra Pediatric Japan Post-Marketing Study(PMS)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Benralizumab (Medi-563) CI brief — competitive landscape report
- Benralizumab (Medi-563) updates RSS · CI watch RSS
- AstraZeneca portfolio CI