benralizumab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. benralizumab appears in the FDA drug-label database. Marketed as FASENRA.
- Drug class
- Interleukin-5 Receptor alpha-directed Cytolytic Antibody (FDA established pharmacologic class)
- Mechanism of action
- Interleukin 5 Receptor alpha-directed Antibody Interactions (as stated on the FDA label)
FDA-approved use
FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. ( 1.1 ) • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). ( 1.2 ) • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. ( 1.3 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. (1.1) 1.1 Asthma FASENRA is indicated for the add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. Limitations of Use: • FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Eosinophilic Granulomatosis with Polyangiitis FASENRA is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). 1.3 Hypereosinophilic Syndrome FASENRA is indicated for the treatment of adult and pediatric patients aged 12 years and older with…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility: — ASTRAZENECA PHARMACEUTICALS | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2025-10-08 |
Phase breakdown
Conditions being studied
Recruiting trials involving benralizumab
- A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in Italy
- Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
- 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
- Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment
- This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab
Common questions
Is benralizumab FDA-approved?
Yes, marketed as FASENRA.
How many recruiting trials involve benralizumab?
5 recruiting trials across 8 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.