CLINICAL TRIALS PROFILE FOR BENRALIZUMAB

All Clinical Trials for benralizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02130882 ↗	Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome	Active, not recruiting	AstraZeneca	Phase 2/Phase 3	2014-05-19	Background: - Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES. Objective: - To test if benralizumab can safely decrease eosinophils in people with HES. Eligibility: - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels. Design: - Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests. - Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells. - Phase 1: Participants will randomly receive either the study drug or placebo as an injection. - They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects. - They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection. - Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug. - At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy. - After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months.
NCT02130882 ↗	Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome	Active, not recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2/Phase 3	2014-05-19	Background: - Eosinophils are white blood cells that help fight infections. High eosinophil levels can damage people s organs, causing hypereosinophilic syndrome (HES). Researchers want to study if the drug benralizumab can help people with HES. Objective: - To test if benralizumab can safely decrease eosinophils in people with HES. Eligibility: - Adults age 18-65 who have been on stable HES therapy for at least 1 month but still have symptoms and high eosinophil levels. Design: - Participants will be screened with medical history, physical exam, and urine and blood tests. They will take simple heart and lung tests. - Participants will also have a bone marrow biopsy. A numbing medicine is injected into the outer covering of the bone. Then a needle is inserted into the bone. A fast suction movement takes bone marrow cells. - Phase 1: Participants will randomly receive either the study drug or placebo as an injection. - They will have daily visits for the next 3 days, then 4 weekly visits, and then 4 biweekly visits. Each time, they will have medical history, physical exam, blood tests, and a check of side effects. - They will receive another dose of the study drug or placebo at 1 month and 2 months after the first injection. - Phase 2 repeats the Phase 1 schedule. All participants will receive the study drug. - At 1 visit, participants will also receive a vaccine. At 4 visits, they will repeat the heart and lung tests. They will also have one other bone marrow biopsy. - After week 24, participants will receive the study drug either 6 times over 6 months or twice over 6 months.
NCT02138916 ↗	Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History	Completed	MedImmune LLC	Phase 3	2014-06-13	The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies
NCT02138916 ↗	Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History	Completed	AstraZeneca	Phase 3	2014-06-13	The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies
NCT02155660 ↗	Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History	Completed	MedImmune LLC	Phase 3	2014-06-25	The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

Clinical Trial Conditions for benralizumab

Condition Name

Condition Name for benralizumab
Intervention	Trials
Asthma	11
Asthma; Eosinophilic	3
Moderate to Very Severe Chronic Obstructive Pulmonary Disease	2
Nasal Polyps	2

Condition MeSH

Condition MeSH for benralizumab
Intervention	Trials
Asthma	14
Pulmonary Eosinophilia	8
Pulmonary Disease, Chronic Obstructive	3
Lung Diseases, Obstructive	3

Clinical Trial Locations for benralizumab

Trials by Country

Trials by Country for benralizumab
Location	Trials
United States	190
Canada	21
Japan	12
Germany	9
France	8

Trials by US State

Trials by US State for benralizumab
Location	Trials
Colorado	9
Texas	8
California	7
Alabama	7
Maryland	7

Clinical Trial Progress for benralizumab

Clinical Trial Phase

Clinical Trial Phase for benralizumab
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for benralizumab
Clinical Trial Phase	Trials
Recruiting	15
Completed	8
Not yet recruiting	3

Clinical Trial Sponsors for benralizumab

Sponsor Name

Sponsor Name for benralizumab
Sponsor	Trials
AstraZeneca	21
Iqvia Pty Ltd	2
Parexel	2

Sponsor Type

Sponsor Type for benralizumab
Sponsor	Trials
Industry	36
Other	27
UNKNOWN	4

Benralizumab: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Benralizumab, marketed under the brand name Fasenra, is a monoclonal antibody developed by AstraZeneca targeting the interleukin-5 receptor alpha (IL-5Rα). This biologic therapy addresses severe eosinophilic asthma, a subset of asthma characterized by elevated eosinophil levels contributing to airway inflammation. With an increasing emphasis on personalized medicine, benralizumab has gained prominence within the biologic asthma treatment landscape. This analysis covers recent clinical trial updates, current market dynamics, and future growth projections for benralizumab.

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Clinical Trials Update

Recent Trial Outcomes

Benralizumab's therapeutic efficacy and safety profile have been extensively validated through pivotal clinical trials, notably the SIROCCO, CALIMA, and ZONDA studies.

• SIROCCO (NCT01928771) and CALIMA (NCT01914757) Trials: These Phase III trials demonstrated significant reductions in exacerbation rates in patients with severe eosinophilic asthma. Patients receiving benralizumab experienced approximately a 51-55% decrease in exacerbations versus placebo (P < 0.001). Lung function, measured via FEV₁, improved substantially, with increases ranging from 0.15 to 0.3 liters.

• ZONDA (NCT02075215): This Phase III trial focused on oral corticosteroid reduction. Results showed a mean corticosteroid dose decrease of 75% in benralizumab recipients compared to 25% in placebo, with 69% of patients achieving at least a 50% reduction versus 25% in the placebo group (P < 0.001). The safety profile remained consistent, with adverse events comparable to placebo.

Ongoing and New Trials

Recent efforts aim to expand benralizumab's indications:

• PLEA (NCT04322793): Evaluating efficacy in adolescents aged 12-17 with eosinophilic asthma.
• BORA (NCT03615091): Investigating long-term safety and efficacy.
• Expansion to Chronic Rhinosinusitis: Preliminary Phase II trials are exploring potential benefits in eosinophilic chronic rhinosinusitis, leveraging benralizumab’s eosinophil-depleting capacity.

Emerging Data and Future Trials

Preliminary data supports benralizumab's potential in other eosinophil-driven diseases, including eosinophilic pneumonia, hypereosinophilic syndrome, and certain atopic conditions. These promising avenues are currently under investigation in early-phase trials.

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Market Analysis

Current Market Landscape

Benralizumab entered the global biologics market for severe asthma in 2017. The biologic segment targeting eosinophilic asthma has become increasingly competitive, with key players like mepolizumab (Nucala) and reslizumab (Cinquair). As of 2022, Fasenra's global sales reached approximately $860 million, reflecting steady growth driven by expanding indications and patient access.

Market Drivers

• Rising Prevalence of Severe Eosinophilic Asthma: Globally, severe asthma affects approximately 5-10% of the total asthma population, coinciding with increased adoption of targeted biologics.
• Advancements in Personalized Medicine: Precision targeting of eosinophils aligns with healthcare shifts towards biomarker-driven treatment.
• Regulatory Approvals: The FDA approved benralizumab for add-on maintenance therapy in severe eosinophilic asthma, bolstering market confidence.
• Patient and Provider Preferences: Parenteral biologics offering corticosteroid sparing benefits translate into improved quality of life, promoting adoption.

Competitive Positioning

Benralizumab’s unique mechanism—inducing antibody-dependent cell-mediated cytotoxicity (ADCC)—facilitates near-complete eosinophil depletion, providing a potential edge over competing therapies that primarily neutralize IL-5. However, market share remains prominent among peers due to similar efficacy and established safety profiles.

Market Challenges

• Pricing and Reimbursement: High costs of biologics remain a barrier, with payers scrutinizing cost-effectiveness.
• Administration Route: Intravenous or subcutaneous injections require clinical visits, impacting patient convenience.
• Competition: Mepolizumab and reslizumab are well entrenched, necessitating clear differentiation for benralizumab.

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Future Market Projections

Growth Outlook (2023-2030)

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% for benralizumab through 2030, outpacing the overall asthma biologics segment. This growth stems from:

• Expanded Indications: Success in clinical trials for eosinophilic conditions beyond asthma.
• Geographical Expansion: Increased approvals in emerging markets like China, India, and Latin America.
• Long-term Safety Profile: Demonstrated safety facilitates broader adoption among clinicians.

Market Penetration Strategies

• Broadened Indication Approvals: Securing regulatory approval for conditions like hypereosinophilic syndrome could substantially increase sales.
• Patient Stratification: Refining biomarker-based algorithms to identify suitable candidates enhances treatment efficacy and market uptake.
• Combination Therapies: Investigating additive effects with other biologics or small molecule therapies may expand the patient pool.
• Manufacturing and Cost Optimization: Improving production efficiencies can support competitive pricing and wider access.

Impact of Competitive Dynamics

While current competitors present a consolidated market, benralizumab’s distinctive ADCC mechanism and consistent clinical data position it favorably for capturing incremental market share. Strategic collaborations and accelerated clinical development could further solidify its position.

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Regulatory and Reimbursement Outlook

The regulatory landscape remains favorable, with approvals in major markets such as the U.S., EU, and Japan. Enhanced real-world evidence supporting corticosteroid-sparing and disease-modifying effects will strengthen reimbursement negotiations. The push for more value-based care models underscores the importance of demonstrating long-term cost savings through biologic therapies.

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Key Takeaways

• Clinical Validation: Recent trials reaffirm benralizumab's efficacy in reducing exacerbations, improving lung function, and enabling corticosteroid reduction in severe eosinophilic asthma.
• Market Position: Benralizumab maintains a competitive edge with its unique mechanism, although market share growth hinges on expanding indications and geographic reach.
• Growth Drivers: Increasing prevalence of eosinophil-driven diseases, advancement in personalized medicine, and favorable regulatory support propel future growth.
• Challenges: Pricing, administration, and competition necessitate strategic differentiation and cost management.
• Future Potential: Broadening indications, more global approvals, and real-world evidence will underpin sustained revenue expansion.

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FAQs

1. What distinguishes benralizumab from other eosinophil-targeting biologics?
Benralizumab uniquely induces eosinophil apoptosis via antibody-dependent cell-mediated cytotoxicity, leading to near-complete depletion. This mechanism distinguishes it from peers like mepolizumab, which neutralizes IL-5 without directly inducing cell death.

2. Are there ongoing trials evaluating benralizumab for diseases beyond asthma?
Yes. Early-phase trials are exploring its potential in eosinophilic chronic rhinosinusitis, hypereosinophilic syndrome, and eosinophilic pneumonia, among other conditions.

3. How significant is the market opportunity for benralizumab in emerging markets?
Emerging markets represent substantial growth potential due to increasing asthma prevalence, expanding healthcare infrastructure, and regulatory approvals, likely fueling double-digit CAGR in these regions.

4. What are the main barriers to broader adoption of benralizumab?
High treatment costs, need for clinical administration, and competition from existing biologics are primary barriers. Demonstrating superior efficacy and cost-effectiveness is crucial for overcoming these.

5. How might future clinical data influence benralizumab’s market trajectory?
Positive long-term safety data, evidence of disease-modifying effects, and approval for additional indications will enhance clinician confidence and payer support, accelerating market penetration.

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Sources

1. Bleecker ER, et al. Efficacy and safety of benralizumab for severe eosinophilic asthma. N Engl J Med. 2016;375(20):1980-1991.
2. Bel EH, et al. Oral glucocorticoid down-titration in severe asthma with benralizumab: The ZONDA study. Lancet Respir Med. 2019;7(9):747-761.
3. AstraZeneca. Fasenra (benralizumab) prescribing information. 2022.
4. GlobalData Healthcare. Biologic Therapeutics Market Report. 2023.
5. IQVIA. The Future of Biologics in Respiratory Diseases. 2022.

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This comprehensive review equips industry stakeholders with critical insights to inform investment, development, and strategic planning surrounding benralizumab's evolving commercial landscape.