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 Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
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
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: 31
Recent & Upcoming Milestones
- Clinical Outcomes Reported - AstraZeneca presented P3 Granulomatosis with Polyangiitis results on 2024-02-23 for Benralizumab
Highest Development Phases
Phase 3: Asthma|Bronchiectasis|Chronic Obstructive Pulmonary Disease|Churg-Strauss Syndrome|Cystic Fibrosis|Eosinophilic Esophagitis|Eosinophilic Granuloma|Gastritis|Gastroenteritis|Granulomatosis with Polyangiitis|Hypereosinophilic Syndrome|Inflammation|Nasal Polyposis|Pemphigoid, Bullous|Pulmonary Eosinophilia|Vasculitis
Phase 2: Chronic Spontaneous Urticaria|Drug Hypersensitivity|Prurigo|Pruritus
Phase 1: COVID-19
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| BENRADRESS | P2 |
Not yet recruiting |
Drug Hypersensitivity |
2029-01-05 |
12% |
2024-12-18 |
Primary Endpoints |
| BICPIC | P2 |
Active, not recruiting |
Pruritus|Prurigo |
2026-05-15 |
|||
| ARROYO | P2 |
Active, not recruiting |
Chronic Spontaneous Urticaria |
2022-11-21 |
85% |
2022-03-13 |
Treatments |
| D3250C00024 | P3 |
Recruiting |
Inflammation|Asthma |
2032-09-30 |
2025-05-02 |
Treatments |
|
| CLIPS | P3 |
Recruiting |
Granulomatosis with Polyangiitis|Eosinophilic Granuloma|Churg-Strauss Syndrome |
2026-10-06 |
70% |
2025-04-30 |
|
| D3253C00001 | P3 |
Active, not recruiting |
Granulomatosis with Polyangiitis|Eosinophilic Granuloma |
2026-03-31 |
2025-05-02 |
Treatments |
|
| STEP | P3 |
Active, not recruiting |
Pulmonary Eosinophilia|Asthma |
2025-10-31 |
88% |
2025-10-11 |
|
| jRCT2031210500 | P3 |
Active, not recruiting |
Gastritis|Gastroenteritis |
2025-09-22 |
|||
| RESOLUTE | P3 |
Completed |
Chronic Obstructive Pulmonary Disease |
2025-07-28 |
76% |
2025-08-20 |
|
| NATRON | P3 |
Active, not recruiting |
Hypereosinophilic Syndrome |
2025-05-07 |
65% |
2025-08-07 |
|
| jRCT2071210014 | P3 |
Recruiting |
Pemphigoid, Bullous |
2024-09-30 |
|||
| NAPPREB | P3 |
Completed |
Nasal Polyposis |
2024-06-28 |
32% |
2025-08-27 |
Primary Endpoints|Treatments |
| jRCT2061200026 | P3 |
Completed |
Eosinophilic Esophagitis |
2024-04-22 |
|||
| MAHALE | P3 |
Completed |
Cystic Fibrosis|Bronchiectasis |
2024-04-16 |
81% |
2025-05-06 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
| MANDARA | P3 |
Active, not recruiting |
Vasculitis|Churg-Strauss Syndrome|Eosinophilic Granuloma |
2023-08-10 |
90% |
2023-12-09 |
|
| DOMINICA | P3 |
Recruiting |
Pulmonary Eosinophilia|Asthma |
2030-05-05 |
78% |
2023-07-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| BRISOTE | P3 |
Recruiting |
Asthma|Pulmonary Eosinophilia |
2027-11-02 |
2025-05-29 |
Primary Endpoints |
|
| D3250C00101 | P3 |
Not yet recruiting |
Asthma |
2027-10-16 |
2025-05-02 |
Treatments |
|
| D3254C00001 | P3 |
Active, not recruiting |
Hypereosinophilic Syndrome |
2027-03-09 |
65% |
2025-05-02 |
Treatments |
| D3251C00014 | P3 |
Active, not recruiting |
Chronic Obstructive Pulmonary Disease |
2025-06-27 |
2025-05-02 |
Treatments |
|
| D3252C00002 | P3 |
Completed |
Asthma |
2024-11-12 |
53% |
2025-05-02 |
Treatments |
| jRCT2080225231 | P3 |
Recruiting |
Hypereosinophilic Syndrome |
2024-06-30 |
|||
| HUDSON GI | P3 |
Completed |
Gastroenteritis|Gastritis |
2024-02-13 |
32% |
2025-06-30 |
Treatments |
| MIRACLE | P3 |
Completed |
Asthma |
2023-01-30 |
93% |
2023-02-09 |
|
| CTR20170780 | P3 |
Completed |
Asthma |
2023-01-17 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |