Data updated: May 26, 2026
FASENRA (benralizumab)
Interleukin 5 Receptor alpha-directed Antibody Interactions
Trial Activity: Declining 9 active trials
Respiratory
Approved 2017-11-14
FASENRA (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. It is indicated as an add-on maintenance treatment for adult and pediatric patients aged 6 years and older with severe asthma and an eosinophilic phenotype. Additionally, the medication is approved for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). It is not intended for the relief of acute bronchospasm or status asthmaticus.
How FASENRA Works
Benralizumab binds directly to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) located on the surface of eosinophils and basophils. This binding facilitates an interaction with immune effector cells, such as natural killer cells, to trigger antibody-dependent cell-mediated cytotoxicity (ADCC). This process leads to the apoptosis, or programmed cell death, of eosinophils and basophils. By reducing these cell types, the drug addresses a key component of the inflammation associated with asthma and EGPA.
Development Insights
AstraZeneca conducting 37 trials (73%)
41 indications explored (Broad Platform)
→ asthma (26 trials)
→ chronic obstructive pulmonary disease (3 trials)
→ eosinophilic granulomatosis with polyangiitis (egpa) (2 trials)
5
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-11-14
- Patent Cliff
- 2029
- Revenue
- $475M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
FASENRA Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2017 to 2026 · 4 indication expansions
What FASENRA Treats
2 indicationsFASENRA is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Asthma
- Eosinophilic Granulomatosis with Polyangiitis
Source: FDA Label
FASENRA Target & Pathway
ProTarget
FASENRA Competitive Set
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Drugs Similar to FASENRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
NUCALA
MEPOLIZUMAB
GSK
Shared indications:
AsthmaEosinophilic Granulomatosis with Polyangiitis
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Clinical Trial Registry
46 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06465485 STEP | D3250L00046 | Ph 3 | active not recruiting | STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma |
| NCT04157348 MANDARA results posted | D3253C00001 2023-510248-19-00, 2019-001832-77 | Ph 3 | active not recruiting | Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. |
| NCT05692180 DOMINICA | D3250C00024 | Ph 3 | 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) |
| NCT03953300 CHINOOK | D3250C00059 2018-003391-13 | Ph 4 | active not recruiting | Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics |
| NCT06512883 CLIPS | D3255C00004 2023-508533-14-00, EMEA-001214-PIP09-21-M02(EGPA) | Ph 3 | recruiting | A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases |
| NCT04552288 results posted | 20-344 | Ph 2 | active not recruiting | Study of Benralizumab in People With Skin Side Effects Caused by Cancer Therapies |
| NCT07444567 ROSY-F | D3250N00036 | Ph 3 | not yet recruiting | Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment |
| NCT04191304 NATRON | D3254C00001 2023-510455-28-00, 2019-002039-27 | Ph 3 | active not recruiting | A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) |
| NCT04718389 NIMBLE results posted | 206785 | Ph 3 | completed | A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype |
| NCT03563066 results posted | ESR-16-12430 | Ph 2 | completed | Effect of Benralizumab in Atopic Dermatitis |
| NCT04053634 RESOLUTE | D3251C00014 2019-001800-39 | Ph 3 | completed | Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations |
| NCT05006573 MAHALE results posted | D325BC00001 2020-004068-24 | Ph 3 | terminated | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis |
| NCT05251909 HUDSON GI results posted | D3258C00001 2021-000085-14 | Ph 3 | terminated | Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) |
| NCT05384938 FAST results posted | D3250C00093 | Ph 4 | completed | FAsenra Safety Trial in India |
| NCT04612790 FJORD results posted | D325AC00002 2023-505033-27-00, 2020-000287-32 | Ph 3 | terminated | A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. |
| NCT04185012 NAPPREB | NAPPREB | Ph 3 | completed | NAsal Polyps: Inflammatory & Molecular Phenotyping of Responders to Benralizumab |
| NCT05966584 results posted | 22-276 | Ph 2 | terminated | A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer |
| NCT06385236 EPIPHANY | 804913 R01HL161362 | Ph 4 | recruiting | Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping |
| NCT04102800 BenRex | GN17RM684 | Ph 4 | completed | Benralizumab Exacerbation Study |
| NCT03186209 results posted | D3250C00036 2017-000702-38 | Ph 3 | completed | Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) |
| NCT04612725 ARROYO results posted | D3259C00001 2020-000169-17 | Ph 2 | terminated | A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO) |
| NCT04543409 MESSINA results posted | D3255C00001 2019-002871-32 | Ph 3 | terminated | A Study of Benralizumab in Patients With Eosinophilic Esophagitis |
| NCT04605094 results posted | D3256C00001 | Ph 2 | terminated | Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis |
| NCT03557307 PONENTE results posted | D3250C00065 | Ph 3 | completed | Study to Evaluate Efficacy and Safety of Benralizumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma |
| NCT04305405 TATE results posted | D3250C00025 | Ph 3 | completed | PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma |
| NCT03470311 | 17-12992 | Ph 3 | completed | Benralizumab in Patients With Inadequate Response to Anti-IL5 Monoclonal Antibody Therapies |
| NCT03473977 BEGS results posted | 2017-1701 | Ph 2, Ph 3 | completed | Benralizumab for Eosinophilic Gastritis (BEGS) |
| NCT02808819 MELTEMI results posted | D3250C00037 | Ph 3 | completed | A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist |
| NCT03010436 BITE | HS-3010 | Ph 2 | active not recruiting | Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study |
| NCT03450083 results posted | IRB00112910 | Ph 2 | completed | Benralizumab Effect on Severe Chronic Rhinosinusitis With Eosinophilic Polyposis |
| NCT02821416 ARIA results posted | D3250C00040 | Ph 3 | completed | Study to Evaluate the Effect of Benralizumab on Allergen-Induced Inflammation in Mild, Atopic Asthmatics |
| NCT00768079 results posted | MI-CP186 | Ph 2 | completed | A Phase 2 Study to Evaluate the Safety and Efficacy of Intravenously Administered Benralizumab (MEDI-563). |
| NCT02869438 SOLANA results posted | D3250C00038 2016-002094-36, U1111-1185-6625 | Ph 3 | 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 |
| NCT03928262 | D3250C00034 | Ph 1 | completed | Pharmacokinetic Study of Benralizumab in Healthy Chinese Subjects |
| NCT02258542 BORA results posted | D3250C00021 U1111-1162-2422 | Ph 3 | 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 |
| NCT03183024 | SAIRB-17-0036 | Ph 4 | completed | Treatment of Chronic Urticarial Unresponsive to H1-antihistamines With an Anti-IL5Ralpha Monoclonal Antibody |
| NCT02968914 results posted | D3250C00030 | Ph 1 | completed | Pharmacokinetic Comparability of Benralizumab Using Accessorized Pre-Filled Syringe or Autoinjector in Healthy Volunteers |
| NCT02918071 GRECO results posted | D3250C00031 | Ph 3 | completed | Study to Assess Functionality, Reliability, and Performance of a Single-Use Auto-Injector With Benralizumab Administered at Home |
| NCT02814643 ALIZE results posted | D3250C00033 | Ph 3 | 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 |
| NCT02075255 results posted | D3250C00020 | Ph 3 | 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 |
| NCT02417961 results posted | D3250C00029 | Ph 3 | completed | Study to Assess Functionality, Reliability, and Performance of a Pre-filled Syringe With Benralizumab Administered at Home |
| NCT02772419 | 4563-005 | Ph 2 | completed | Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis |
| NCT02322775 results posted | D3250C00032 2014-004427-40 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma |
| NCT01928771 results posted | D3250C00017 | Ph 3 | completed | Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma |
| NCT01914757 results posted | D3250C00018 | Ph 3 | completed | Efficacy and Safety Study of Benralizumab in Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist |
| NCT01947946 results posted | D3250C00016 | Ph 3 | terminated | Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma |
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FASENRA FDA Label Details
Indications & Usage
FDA Label (PDF)FASENRA is indicated for the treatment of Asthma; Eosinophilic Granulomatosis with Polyangiitis.
Pro Intelligence Preview
Deep insights for FASENRA
Revenue Insights
- • Q4-2025: $475M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • Generic/biosimilar risk
Trial Analysis
- • 51 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment