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: None *
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, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 34
Highest Development Phases
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| MAHALE | P3 |
Completed |
Cystic Fibrosis|Bronchiectasis |
2024-04-16 |
81% |
| HUDSON GI | P3 |
Completed |
Gastroenteritis|Gastritis |
2024-02-13 |
32% |
| BICPIC | P2 |
Active, not recruiting |
Prurigo|Pruritus |
2026-05-15 |
|
| D3250C00024 | P3 |
Recruiting |
Asthma|Inflammation |
2032-09-30 |
|
| D3251C00014 | P3 |
Active, not recruiting |
Chronic Obstructive Pulmonary Disease |
2025-06-27 |
|
| D3252C00002 | P3 |
Completed |
Asthma |
2024-11-12 |
|
| D3253C00001 | P3 |
Active, not recruiting |
Granulomatosis with Polyangiitis|Eosinophilic Granuloma |
2026-03-31 |
|
| D3254C00001 | P3 |
Active, not recruiting |
Hypereosinophilic Syndrome |
2027-03-09 |
63% |
| D3250C00101 | P3 |
Not yet recruiting |
Asthma |
2027-10-16 |
|
| jRCT2031210500 | P3 |
Active, not recruiting |
Gastritis|Gastroenteritis |
2025-09-22 |
|
| jRCT2061200026 | P3 |
Completed |
Eosinophilic Esophagitis |
2024-04-22 |
|
| jRCT2071210014 | P3 |
Recruiting |
Pemphigoid, Bullous |
2024-09-30 |
|
| jRCT2080225231 | P3 |
Recruiting |
Hypereosinophilic Syndrome |
2024-06-30 |
|
| MIRACLE | P3 |
Completed |
Asthma |
2023-01-30 |
93% |
| RESOLUTE | P3 |
Active, not recruiting |
Chronic Obstructive Pulmonary Disease |
2025-08-08 |
81% |
| ORCHID | P3 |
Active, not recruiting |
Nasal Polyposis |
2024-08-19 |
53% |
| MANDARA | P3 |
Active, not recruiting |
Churg-Strauss Syndrome|Vasculitis|Eosinophilic Granuloma |
2023-08-10 |
90% |
| NAPPREB | P3 |
Completed |
Nasal Polyposis |
2024-06-28 |
32% |
| NATRON | P3 |
Active, not recruiting |
Hypereosinophilic Syndrome |
2025-05-02 |
63% |
| HUDSON GI | P3 |
Completed |
Gastritis|Eosinophilia|Gastroenteritis|Eosinophilic Esophagitis |
2024-02-13 |
32% |
| DOMINICA | P3 |
Recruiting |
Pulmonary Eosinophilia|Asthma |
2030-05-05 |
91% |
| STEP | P3 |
Active, not recruiting |
Asthma|Pulmonary Eosinophilia |
2025-10-31 |
88% |
| CLIPS | P3 |
Recruiting |
Eosinophilic Granuloma|Granulomatosis with Polyangiitis|Churg-Strauss Syndrome |
2026-10-06 |
80% |
| BENRADRESS | P2 |
Not yet recruiting |
Drug Hypersensitivity |
2029-01-05 |
12% |
| BRISOTE | P3 |
Recruiting |
Asthma|Pulmonary Eosinophilia |
2027-11-03 |