Ozmosi | Benralizumab Drug Profile

Product Description

Benralizumab is a monoclonal antibody that binds to the human interleukin-5 (IL-5) receptor (IL-5R), thereby preventing IL-5 from binding to its receptor and inhibiting differentiation and maturation of eosinophils in the bone marrow. (Sourced from: https://doi.org/10.1186/s12890-020-01220-9)

Mechanisms of Action: IL5 Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Subcutaneous

FDA Designation: *

Approval Status: Approved

Approved Indications: None

Known Adverse Events: None

Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Benralizumab

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam

Active Clinical Trial Count: 32

Recent & Upcoming Milestones

Clinical Outcomes Reported - AstraZeneca presented P3 Hypereosinophilic Syndrome results on 2025-12-06 for Benralizumab
Clinical Outcomes Reported - AstraZeneca presented P3 Hypereosinophilic Syndrome results on 2025-11-07 for Benralizumab
Clinical Outcomes Reported - AstraZeneca presented P3 Granulomatosis with Polyangiitis results on 2024-02-23 for Benralizumab

Highest Development Phases

Phase 2: Chronic Spontaneous Urticaria|Drug Hypersensitivity|Prurigo|Pruritus

Phase 1: COVID-19

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT06734884	BENRADRESS	P2	Not yet recruiting	Drug Hypersensitivity	2029-01-05	12%	2024-12-18	Primary Endpoints
2021-002818-13	BICPIC	P2	Active, not recruiting	Pruritus\|Prurigo	2026-05-15
2020-000169-17	ARROYO	P2	Active, not recruiting	Chronic Spontaneous Urticaria	2022-11-21	85%	2022-03-13	Treatments
2022-501344-14-00	D3250C00024	P3	Recruiting	Inflammation\|Asthma	2032-09-30		2025-05-02	Treatments
2023-510455-28-00	D3254C00001	P3	Active, not recruiting	Hypereosinophilic Syndrome	2027-03-09	66%	2025-05-02	Treatments
NCT06512883	CLIPS	P3	Recruiting	Granulomatosis with Polyangiitis\|Churg-Strauss Syndrome\|Eosinophilic Granuloma	2026-10-06	61%	2025-12-13
2023-510248-19-00	D3253C00001	P3	Active, not recruiting	Eosinophilic Granuloma\|Granulomatosis with Polyangiitis	2026-03-31		2025-05-02	Treatments
NCT06465485	STEP	P3	Active, not recruiting	Asthma\|Pulmonary Eosinophilia	2025-10-31	62%	2025-10-11
jRCT2031210500	jRCT2031210500	P3	Active, not recruiting	Gastritis\|Gastroenteritis	2025-09-22
NCT04053634	RESOLUTE	P3	Completed	Chronic Obstructive Pulmonary Disease	2025-07-28	76%	2025-08-20
jRCT2071210014	jRCT2071210014	P3	Recruiting	Pemphigoid, Bullous	2024-09-30
NCT04185012	NAPPREB	P3	Completed	Nasal Polyposis	2024-06-28	32%	2025-08-27	Primary Endpoints\|Treatments
jRCT2061200026	jRCT2061200026	P3	Completed	Eosinophilic Esophagitis	2024-04-22
2020-004068-24	MAHALE	P3	Completed	Cystic Fibrosis\|Bronchiectasis	2024-04-16	81%	2025-05-06	Patient Enrollment\|Primary Completion Date\|Study Completion Date\|Treatments\|Trial Status
NCT04157348	MANDARA	P3	Active, not recruiting	Vasculitis\|Churg-Strauss Syndrome\|Eosinophilic Granuloma	2023-08-10	64%	2023-12-09
NCT05692180	DOMINICA	P3	Recruiting	Pulmonary Eosinophilia\|Asthma	2030-05-05	65%	2023-07-20	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
NCT06750289	BRISOTE	P3	Recruiting	Pulmonary Eosinophilia\|Asthma	2027-11-02		2025-05-29	Primary Endpoints
2024-515162-13-00	D3250C00101	P3	Not yet recruiting	Asthma	2027-10-16		2025-05-02	Treatments
CTR20211104	CTR20211104	P3	Completed	Chronic Obstructive Pulmonary Disease	2025-07-28		2025-11-16	Patient Enrollment\|Primary Completion Date\|Study Completion Date\|Treatments\|Trial Status
2022-503050-39-00	D3251C00014	P3	Active, not recruiting	Chronic Obstructive Pulmonary Disease	2025-06-27		2025-05-02	Treatments
NCT04191304	NATRON	P3	Active, not recruiting	Hypereosinophilic Syndrome	2025-05-07	66%	2025-08-07
2023-507987-38-00	D3252C00002	P3	Completed	Asthma	2024-11-12	53%	2025-05-02	Treatments
jRCT2080225231	jRCT2080225231	P3	Recruiting	Hypereosinophilic Syndrome	2024-06-30
2021-000085-14	HUDSON GI	P3	Completed	Gastritis\|Gastroenteritis	2024-02-13	32%	2025-06-30	Treatments
NCT03186209	MIRACLE	P3	Completed	Asthma	2023-01-30	93%	2023-02-09

Recent News Events

Date	Type	Title
12/04/2025	News Article	AstraZeneca advances hematology and cell therapy ambition with largest-ever presence at ASH
11/07/2025	News Article	Statistically significant NATRON Phase III trial results for hypereosinophilic syndrome show FASENRA delayed time to first flare or worsening of disease
11/06/2025	News Article	AstraZeneca's 9M and Q3 2025 Financial Results
10/20/2025	News Article	Asthma Treatment Market Size Worth USD 35.93 Billion by 2034

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Benralizumab

Alternative Names: benralizumab, khk4563, medi-563, Fasenra, medi563, khk-4563, iw8405, BIW-8405, iw-8405, biw8405 Clinical Status: Active Latest Update: 2025-12-12 Latest Update Note: Clinical Trial Update