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

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

Condition MeSH

Condition MeSH for benralizumab
Intervention	Trials
Asthma	14
Pulmonary Eosinophilia	8
Churg-Strauss Syndrome	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
New Jersey	7
Florida	7
California	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
Johns Hopkins University	2
Iqvia Pty Ltd	2

Sponsor Type

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

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

Last updated: February 20, 2026

What is the current status of benralizumab clinical trials?

Benralizumab, marketed as Fasenra by AstraZeneca, is a monoclonal antibody targeting the alpha-subunit of the interleukin-5 receptor (IL-5Rα). It is approved for severe eosinophilic asthma and is under investigation for other eosinophil-related diseases.

Approved Indications

• Severe eosinophilic asthma (FDA approval in 2017, EMA approval in 2018)
• Chronic obstructive pulmonary disease (COPD) with eosinophilic phenotype (studies ongoing)

Key Clinical Trials

Trial Name	Phase	Status	Indication	Completion Date	Results Summary
SIROCCO (NCT01928771)	Phase 3	Completed	Severe eosinophilic asthma	2017	Reduced exacerbations, improved lung function
CALIMA (NCT01914757)	Phase 3	Completed	Severe eosinophilic asthma	2016	Similar efficacy as SIROCCO; sustained benefits
ZONDA (NCT02493709)	Phase 3	Completed	Reducing oral corticosteroid use	2018	Significant corticosteroid dose reduction
DESTROY (NCT03474473)	Phase 3	Ongoing	Eosinophilic COPD	2023	Data pending; focused on exacerbation reduction
ORCHID (NCT03488455)	Phase 3	Completed	Severe eosinophilic asthma	2020	Validated previous efficacy findings
Additional trials	Phase 1/2	Ongoing / Completed	Various eosinophil-driven conditions	2023+	Exploring nasal polyposis, eosinophilic esophagitis, and more

Recent Developments

• Nasal polyposis trials (NCT03615758): Phase 2 studies showed reduction in nasal polyp size.
• Eosinophilic esophagitis studies: Preliminary phase 2 data indicates potential benefit.

How has market availability influenced research?

Approval has spurred multiple phase 4 studies and off-label explorations.

• Prescription volumes increased post-approval, especially in North America and Europe.
• AstraZeneca received EUA authorization in Japan for eosinophilic asthma.
• Off-label uses include eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

What is the market analysis for benralizumab?

Market Size and Drivers

• 2022 global asthma therapeutics market: USD 21.5 billion.
• Eosinophilic asthma segment: approx. 25% of the total.
• Benralizumab share: Estimated at 10%, with a revenue of USD 2.15 billion in 2022.
• Projected growth rate: Compound annual growth rate (CAGR) of 12% from 2023-2028.

Competitive Position

Drug	Company	Approved Indication	Market Share (2022)	Notable Features
Mepolizumab (Nucala)	GlaxoSmithKline	Severe eosinophilic asthma	50%	First IL-5 inhibitor approved
Reslizumab (Cinqair)	Teva	Severe eosinophilic asthma	15%	IV administration
Benralizumab	AstraZeneca	Severe eosinophilic asthma	20%	Subcutaneous, single-dose efficacy
Other competitors	Various	Various	15%	Emerging therapies and biosimilars

Market Trends

• Expanding indications: COPD, nasal polyposis, HES.
• Geographic expansion: Regulator approvals in Japan, parts of Asia, and Latin America.
• Pricing: USD 3,000–3,500 per dose; total annual cost USD 25,000–30,000.

Challenges

• Competition from newer biologics with different mechanisms.
• Cost-effectiveness debates.
• Need for broader indication approvals.

What are the future projections?

Sales Forecasts

Year	Expected Revenue (USD billion)	Growth Rate	Notes
2023	2.4	12%	Market penetration continues
2024	2.7	12.5%	Expanded labeling, more off-label use
2025	3.0	11%	Additional regulatory approvals
2026	3.4	13%	Entering broader eosinophil-related conditions markets

Outlook

• Growth driven by new indications, geographical expansion, and increased adoption.
• Emerging evidence may position benralizumab as a first-line biologic for eosinophilic asthma.
• Potential for combination therapies and personalized medicine approaches.

Key Takeaways

• Benralizumab has a robust clinical trial portfolio with multiple Phase 3 successes, primarily for eosinophilic asthma.
• Market presence expanded since 2017; competition remains strong, with sales expected to grow 11-13% annually for the next five years.
• Off-label and new indication studies could further boost its utilization.
• Cost remains a barrier in some markets, but expanding indications and approvals will elevate market size.

FAQs

Q1. What makes benralizumab different from other IL-5 inhibitors?
It induces antibody-dependent cell-mediated cytotoxicity, leading to rapid depletion of eosinophils, which may translate into better efficacy in some patients.

Q2. Which new indications are most promising for benralizumab?
Nasal polyposis and eosinophilic esophagitis show early signs of benefit in Phase 2 trials.

Q3. How does benralizumab’s pricing compare with competitors?
Pricing per dose is similar to mepolizumab but higher than generic options. Annual costs range from USD 25,000 to 30,000.

Q4. Are there any significant safety concerns?
Similar to other biologics targeting eosinophils, adverse events mainly include injection site reactions and mild hypersensitivity.

Q5. What are barriers to wider adoption of benralizumab?
High costs, need for broad regulatory approval for additional indications, and competition from other biologics with different mechanisms.

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References

[1] AstraZeneca. (2022). Fasenra (benralizumab) prescribing information.
[2] Grand View Research. (2023). Eosinophilic Asthma Market Size, Share & Trends.
[3] ClinicalTrials.gov. (2023). List of ongoing and completed benralizumab trials.
[4] EvaluatePharma. (2023). Biologic drug market outlook.