benralizumab
Trade name: fasenra
mAbapproved
Approved
Nov 14, 2017
Benralizumab, sold under the brand name Fasenra, is a monoclonal antibody directed against the alpha chain of the interleukin-5 receptor (CD125). It was developed by MedImmune for the treatment of asthma. It is currently marketed by Astrazeneca. — Wikipedia
Clinical trial activity
73 trials · 54 clinical orgs · 1 marketing orgs
Phase 1
5
Phase 2
55
Phase 3
35
Phase 4
11
Earliest trial started Nov 1, 2006 (NCT00512486)
Timeline
2010s
- Jan 1, 2013
AstraZeneca — Earliest Phase 3 Sponsor(trial)
- Nov 14, 2017
AstraZeneca — Earliest FDA Approval
- Nov 14, 2017
AstraZeneca — Marketing Organization
- Nov 14, 2017
AstraZeneca — NDA Organization
Indications
Approved for
Studied for
- Airway Remodeling · Phase 4
- Anti-Asthmatic Agents · Phase 2
- Aspergillosis · Phase 4
- Aspergillosis, Allergic Bronchopulmonary · Phase 4
- Asthma, Exercise-Induced · Phase 3
- Breast Neoplasms · Phase 2
- Chronic Urticaria · Phase 4
- Churg-Strauss Syndrome · Phase 3
- Cystic Fibrosis · Phase 3
- Dermatitis · Phase 2
- Dermatitis, Atopic · Phase 2
- Drug Hypersensitivity Syndrome · Phase 2
- Eczema · Phase 2
- Eosinophilia · Phase 2
- Eosinophilic Esophagitis · Phase 3
- Eosinophilic Granuloma · Phase 3
- Eosinophils · Phase 2
- Gastritis · Phase 3
- Gastroenteritis · Phase 3
- Genetic Diseases, Inborn · Phase 2
- Healthy Volunteers · Phase 1
- Hematologic Diseases · Phase 2
- Hematologic Neoplasms · Phase 2
- Hypereosinophilic Syndrome · Phase 3
- Hypersensitivity · Phase 2
- Hypersensitivity, Immediate · Phase 2
- Immune System Diseases · Phase 2
- Leukocyte Disorders · Phase 2
- Nasal Polyps · Phase 3
- Neoplasms · Phase 2
- Pemphigoid, Bullous · Phase 3
- Prurigo · Phase 2
- Pulmonary Disease, Chronic Obstructive · Phase 3
- Respiratory System Agents · Phase 2
- Sinusitis · Phase 3
- Skin Diseases · Phase 2
- Skin Diseases, Eczematous · Phase 2
- Skin Diseases, Genetic · Phase 2
Mechanism of action
- Interleukin-5 receptor subunit alphaINHIBITOR
IL5RA inhibitor
Binds to an epitope on IL5RA which is in close proximity to the IL-5 binding site and thus inhibits IL-5 receptor signaling, independent of ligand.
Approval history
- approvedNov 14, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaBenralizumab ↗
- NCATS71492GE1FX ↗
- ChEMBLCHEMBL1742991 ↗
Also known as
- benralizumab
- benralizumab
- benralizumab
- benralizumab
- benralizumab
- biw-8405
- khk4563
- medi-563
- medi-563
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06750289 | Phase 3 | Mar 31, 2025 | AstraZeneca, Clinical Research Trials of Florida, Inc., University of Colorado, Denver |
| NCT06734884 | Phase 2 | Jan 6, 2025 | AstraZeneca, University of Lille |
| NCT06512883 | Phase 3 | Sep 2, 2024 | AstraZeneca |
| NCT06501807 | N/A | Sep 2, 2024 | University of Lille |
| NCT06288516 | Phase 4 | Mar 1, 2024 | Aristotle University of Thessaloniki, University of Crete, University of Patras |
| NCT06465485 | Phase 3 | Feb 28, 2024 | AstraZeneca, Zhejiang University |
| NCT06385236 | Phase 4 | Feb 19, 2024 | Harvard University, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), University of Arizona, University of California, San Diego, Yale University |
| NCT05966584 | Phase 2 | Jul 6, 2023 | AstraZeneca, Memorial Sloan-Kettering Cancer Center, Novartis |
| NCT05692180 | Phase 3 | Apr 5, 2023 | AstraZeneca, Parexel |
| NCT05528913 | Phase 2 | Jan 1, 2023 | Charité University, Berlin, Germany, Humboldt University |
| NCT05273359 | Phase 2 | Oct 31, 2022 | AstraZeneca, Temple University |
| NCT05552508 | Phase 4 | Oct 11, 2022 | AstraZeneca |
| NCT05251909 | Phase 3 | Jan 18, 2022 | AstraZeneca, University of Cincinnati |
| NCT05384938 | Phase 4 | Nov 19, 2021 | AstraZeneca |
| NCT05006573 | Phase 3 | Jul 21, 2021 | AstraZeneca, University of Dublin |
| NCT04617171 | Phase 2 | Jun 2, 2021 | Singapore General Hospital |
| NCT04718389 | Phase 3 | Jan 26, 2021 | GlaxoSmithKline, IQVIA |
| NCT04565483 | Phase 4 | Dec 31, 2020 | AstraZeneca, Government of France, University of Nantes |
| NCT04605094 | Phase 2 | Nov 12, 2020 | AstraZeneca, IQVIA, Mount Sinai Hospital, Canada |
| NCT04612790 | Phase 3 | Nov 3, 2020 | AstraZeneca, University of Iowa |
Showing 20 of 73 trials
Page 1 / 4
Organizations
Research & Development (54)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 53 | 39 | 5 | 2010 |
| MedImmune | For profit | 8 | 6 | 3 | 2006 |
| IQVIA | For profit | 4 | 0 | 2 | 2019 |
| University of Colorado, Denver | Academic/Hospital | 4 | 1 | 2 | 2016 |
| Parexel | For profit | 3 | 0 | 2 | 2017 |
| Pulmonary Research Institute of Southeast Michigan | Academic/Hospital | 3 | 0 | 1 | 2015 |
| Temple University | Academic/Hospital | 3 | 1 | 2 | 2014 |
| University of Cincinnati | Academic/Hospital | 3 | 1 | 2 | 2018 |
| University of Western Ontario | Academic/Hospital | 3 | 1 | 2 | 2014 |
| Allergy, Pulmonary, and Critical Care Medicine, Madison, WI | Academic/Hospital | 2 | 0 | 1 | 2013 |
| Harvard University | Academic/Hospital | 2 | 0 | 2 | 2014 |
| Humboldt University | Academic/Hospital | 2 | 1 | 1 | 2020 |
| Johns Hopkins University | Academic/Hospital | 2 | 1 | 2 | 2016 |
| Kyowa Hakko Kirin | For profit | 2 | 2 | 1 | 2011 |
| McMaster University | Academic/Hospital | 2 | 2 | 2 | 2018 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 2 | 2 | 1 | 2020 |
| University of Lille | Academic/Hospital | 2 | 2 | 2 | 2024 |
| Aristotle University of Thessaloniki | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Bernstein Clinical Research Center | Academic/Hospital | 1 | 1 | 1 | 2017 |
54 organizations
Page 1 / 3
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | Nov 14, 2017 |
| AstraZeneca | For profit | NDA | Nov 14, 2017 |