Benralizumab clinical trials
Benralizumab is named as an intervention in 13 current clinical trials in our France, USA, Italy, UK, Canada, Israel, Poland, Belgium, India, Netherlands, South Korea, Germany, Japan, China, Spain, Denmark, Austria, Taiwan, Turkey, Sweden, Brazil and Mexico registers. 7 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (7). The most-studied condition is Asthma. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Benralizumab is approved
All regulators →Of the three regulators tracked here, the first to approve Benralizumab was the US, on 14 Nov 2017. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Benralizumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Benralizumab works
All drug targets →- Interleukin-5 receptor subunit alpha inhibitor InhibitorTarget: IL5RA interleukin 5 receptor subunit alpha✓ In ChEMBL and the Guide to Pharmacology
- DysphagiaPhase 3
- Nasal polyposisPhase 3
- BronchiectasisPhase 3
- Bullous pemphigoidPhase 3
- Chronic obstructive pulmonary diseasePhase 3
- Chronic rhinosinusitis with nasal polypsPhase 3
- Eosinophilic esophagitisPhase 3
- Eosinophilic gastroenteritisPhase 3
- Eosinophilic granulomatosis with polyangiitisPhase 3
- Hypereosinophilic syndromePhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1742991, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7674, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Benralizumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Benralizumab. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Benralizumab for treating relapsing or refractory eosinophilic granulomatosis with polyangiitis NICE TA1096 | Optimised | 3 Sep 2025 | Current |
| Benralizumab for treating severe eosinophilic asthma NICE TA565 | Optimised | 6 Mar 2019 Updated 3 Sep 2019 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Benralizumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: FasenraEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Benralizumab
- ATC code
- R03DX10
- ChEMBL
- CHEMBL1742991
- DrugBank
- DB12023
- CAS number
- 1044511-01-4
- FDA UNII
- 71492GE1FX
- Wikidata
- Q3638304
- Wikipedia
- Benralizumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Benralizumab
13 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Benralizumab in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Benralizumab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
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
2025-523307-29-00 · Respiratory Tract Diseases
|
Phase 3 | Ongoing | AstraZeneca AB | Denmark, Belgium, France + 4 more |
|
Phase III, Open-label Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, Efficacy, and Immunogenicity of Benralizumab in Children with Eosinophilic Disease (CLIPS)
2023-508533-14-00 · Immune System Diseases
|
Phase 3 | Ongoing | AstraZeneca AB | Poland, Netherlands, France |
|
BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)
2025-524741-28-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 4 | Authorised | Amsterdam UMC Stichting | Netherlands |
Benralizumab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Benralizumab on the HPRA medicines list.
- Fasenra 30 mg solution for injectionAstraZeneca AB · EU/1/17/1252/001-002
Supply shortages
No entry for Benralizumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Benralizumab
13 conditionsAll 13 conditions
| Condition (as registered) | Trials |
|---|---|
| Asthma | 4 |
| Eosinophilic Granulomatosis With Polyangiitis (EGPA) | 3 |
| Severe Asthma | 2 |
| Asthma; Eosinophilic | 2 |
| Eosinophilic Granulomatous Vasculitis | 1 |
| Hypereosinophilic Syndrome | 1 |
| Hypereosinophilic Syndrome (HES) | 1 |
| Hypereosinophilia Syndrome (HES) | 1 |
| Allergic Bronchopulmonary Aspergillosis | 1 |
| ABPA | 1 |
| DRESS Syndrome | 1 |
| Severe Eosinophilic Asthma | 1 |
| Pulmonary Disease | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| AstraZeneca | 7 |
| Qianfoshan Hospital | 1 |
| Nantes University Hospital | 1 |
| University Hospital, Lille | 1 |
| European EGPA Study Group | 1 |
| Dr. Grace Parraga | 1 |
| Taichung Veterans General Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Benralizumab trials
How many clinical trials are testing Benralizumab?
13 current trials in our France, USA, Italy, UK, Canada, Israel, Poland, Belgium, India, Netherlands, South Korea, Germany, Japan, China, Spain, Denmark, Austria, Taiwan, Turkey, Sweden, Brazil and Mexico registers name Benralizumab as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Benralizumab trials recruiting patients?
Yes. 7 of the 13 trials are recruiting: 3 with sites in France, 2 with sites in USA, 3 with sites in Italy, 1 with sites in UK, 2 with sites in Canada, 2 with sites in Israel, 2 with sites in Poland, 1 with sites in Belgium, 2 with sites in India, 2 with sites in Netherlands, 1 with sites in South Korea, 1 with sites in China, 1 with sites in Austria, 1 with sites in Taiwan, 2 with sites in Turkey, 1 with sites in Brazil and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Benralizumab clinical trials?
AstraZeneca (7), Qianfoshan Hospital (1), Nantes University Hospital (1) and University Hospital, Lille (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Benralizumab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Benralizumab, for example Fasenra 30 mg solution for injection (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Benralizumab shortage?
Not in the lists we track: Benralizumab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Benralizumab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Benralizumab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Benralizumab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.