Drugs / Benralizumab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | FASENRA | — | 2019-10-03 – 2026-05-13 | fda.gov ↗ |
| Approved | EU (EMA) | Fasenra | — | 2018-01-08 | europa.eu ↗ |
| Approved | US (FDA) | FASENRA | — | 2017-11-14 | fda.gov ↗ |
Trials 65 · started per year
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US approved 2017
EU approved 2018
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03928262 | Apr → Aug 2019 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02968914 | Jan → Jul 2017 | asthma, chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00659659 | Jan 2008 → Jan 2011 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| Phase 2 | NCT06734884 | Jan 2027 → Jan 2029 expected | drug rash with eosinophilia and systemic symptoms | University Hospital, Lille | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05528913 | Oct 2023 | prurigo | Charite University, Berlin, Germany | Withdrawn | No outcome recorded |
| Phase 2 | NCT05966584 | Jul 2023 → Aug 2024 | breast cancer | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04617171 | Jun 2021 → Aug 2023 | acute asthma | Singapore General Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04098718 | Mar 2021 → Feb 2024 | asthma, chronic obstructive pulmonary disease | University of Oxford | Unknown | No outcome recorded |
| Phase 2 | NCT04605094 | Nov 2020 → Apr 2022 | atopic eczema | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT04612725 | Oct 2020 → Oct 2022 | chronic urticaria | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT04552288 | Sep 2020 → Jul 2024 | carcinoma, hematopoietic and lymphoid cell neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03563066 | Sep 2018 → Sep 2021 | atopic eczema | McMaster University | Completed | No outcome recorded |
| Phase 2 | NCT03010436 | Apr 2017 → Jul 2019 overdue | asthma | National Jewish Health | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02772419 | Jun 2016 → Mar 2017 | chronic rhinosinusitis | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01238861 | Dec 2010 → Mar 2013 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT01227278 | Nov 2010 → Jan 2013 | chronic obstructive pulmonary disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00768079 | Feb 2009 → Dec 2010 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00783289 | Nov 2008 → Nov 2009 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03473977 | Apr 2018 → Jun 2020 | eosinophilic gastrointestinal disease | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 333 trials | ||||||
| Phase 3 | NCT07444567 | May 2026 → Dec 2029 expected | asthma, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome | AstraZeneca | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06512883 | Apr 2025 → Feb 2028 expected | eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06750289 | Mar 2025 → Nov 2028 expected | T2-high asthma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06465485 | Feb 2024 → May 2026 overdue | chronic asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05692180 | Apr 2023 → May 2030 expected | asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05251909 | Jan 2022 → Feb 2024 | eosinophilic gastritis | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT05006573 | Jul 2021 → Apr 2024 | bronchiectasis | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04612790 | Mar 2021 → Oct 2023 | bullous pemphigoid | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04543409 | Sep 2020 → Sep 2022 | eosinophilic esophagitis | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04191304 | Jul 2020 → May 2025 overdue | hypereosinophilic syndrome | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04185012 | Feb 2020 → Jun 2024 | nasal cavity polyp | Humanitas Clinical and Research Center | Completed | No outcome recorded |
| Phase 3 | NCT04157335 | Nov 2019 → Aug 2024 | chronic rhinosinusitis, nasal cavity polyp | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04305405 | Nov 2019 → Sep 2022 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT04157348 | Oct 2019 → Aug 2023 overdue | eosinophilic granulomatosis with polyangiitis | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04053634 | Aug 2019 → Jul 2025 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03557307 | Aug 2018 → Apr 2021 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03401229 | Jan 2018 → Jul 2020 | nasal cavity polyp | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03186209 | Sep 2017 → Jan 2023 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03170271 | Jul 2017 → Sep 2019 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02918071 | Nov 2016 → Aug 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02869438 | Nov 2016 → Aug 2018 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02821416 | Oct 2016 → Oct 2019 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02814643 | Jul 2016 → Jan 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02808819 | Jun 2016 → Jun 2020 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02417961 | Apr 2015 → Mar 2016 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02322775 | Feb → Oct 2015 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02258542 | Nov 2014 → Oct 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02155660 | Jun 2014 → Apr 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02138916 | Jun 2014 → Apr 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02075255 | Apr 2014 → Aug 2016 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01947946 | Nov 2013 → Jul 2014 | asthma | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT01928771 | Sep 2013 → Apr 2016 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01914757 | Aug 2013 → Mar 2016 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07654842 | Jul 2026 → Sep 2027 expected | asthma | Endeavor Health | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06288516 | Mar 2024 → Dec 2025 | asthma | Aristotle University Of Thessaloniki | Unknown | No outcome recorded |
| Phase 4 | NCT05552508 | Oct 2022 → Jul 2024 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT05384938 | Nov 2021 → Jul 2023 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT04565483 | Oct 2021 → Oct 2026 expected | asthma | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04108962 | Dec 2019 → Sep 2021 | allergic bronchopulmonary aspergillosis, asthma | Baylor Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT03953300 | Oct 2019 → Oct 2026 expected | asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04102800 | Sep 2019 → Feb 2024 | asthma | NHS Greater Glasgow and Clyde | Completed | No outcome recorded |
| Phase 4 | NCT03652376 | Sep 2018 → May 2019 | T2-high asthma | University of Rostock | Unknown | No outcome recorded |
| Phase 4 | NCT03183024 | Sep 2017 → Nov 2018 | chronic idiopathic urticaria | Jonathan A. Bernstein, MD | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06501807 | Jul 2024 → Sep 2034 expected | chronic rhinosinusitis, nasal cavity polyp | University Hospital, Lille | Recruiting | No outcome recorded |
| — | NCT03733535 | Mar 2022 overdue | asthma | Dr. Grace Parraga | Active not recruiting | No outcome recorded |
| — | NCT03976310 | Jun 2019 → Jun 2023 | asthma | University Hospital, Montpellier | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00512486 Comparator | Nov 2006 → Sep 2008 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05273359 Comparator | Apr 2023 → Jun 2024 | chronic obstructive pulmonary disease | Temple University | Unknown | No outcome recorded |
| Phase 2 | NCT03450083 Comparator | Jul 2017 → Jan 2020 | chronic rhinosinusitis, eosinophil disorder, nasal cavity polyp | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02130882 Comparator | May 2014 → Jun 2020 | hypereosinophilic syndrome, respiratory system disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT04718389 Comparator | Jan 2021 → Sep 2025 | asthma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03470311 Comparator | Apr 2018 → Jun 2022 | asthma | McMaster University | Completed | No outcome recorded |
| Phase 3 | NCT03327701 Comparator | Dec 2017 → Dec 2019 | exercise-induced bronchoconstriction | Louis-Philippe Boulet | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06385236 Comparator | Feb 2024 → Jun 2027 expected | asthma | University of California, San Diego | Recruiting | No outcome recorded |
| Phase 4 | NCT04159519 Background | Jul 2020 → Jan 2023 | asthma | AstraZeneca | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-17 | AstraZeneca | Update on the RESOLUTE Phase III trial for Fasenra in chronic obstructive pulmonary disease astrazeneca.com ↗ |
| 2024-10-28 | AstraZeneca | Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗ |
| 2024-09-23 | AstraZeneca | Fasenra recommended for approval in the EU by CHMP for the treatment of eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗ |
| 2024-09-18 | AstraZeneca | Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗ |
| 2024-08-20 | AstraZeneca | Fasenra approved in China for the treatment of severe eosinophilic asthma astrazeneca.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Benralizumab | “Benralizumab (Anti-IL5Rα)” NCT05528913 ↗69 |
| Known as | BENRA | “Benralizumab (BENRA), an afucosylated monoclonal antibody that binds interleukin 5 receptor α expressed on eosinophils, reduced blood and tissue eosinophils in a 48-week, phase...” PMID 40120806 ↗ Mar 2025 |
| Known as | BIW-8405 | “The primary objective of this study is to investigate the safety of administration of BIW-8405/MEDI-563 in increasing doses to male and female adult subjects with mild asthma.” NCT00512486 ↗ |
| Known as | Fasenra | “Benralizumab 30 MG/ML [Fasenra]” NCT06734884 ↗ |
| Known as | KHK4563 | “Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis” NCT02772419 ↗ |
| Known as | MEDI-563 | “A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled...” NCT01947946 ↗10“A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled...” NCT01928771 ↗ “To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute...” NCT01227278 ↗ “A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)” NCT02808819 ↗ “Benralizumab (MEDI-563) injection 25 milligram (mg) subcutaneously on Day 0, 28, and 56.” NCT00783289 ↗ “benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use” NCT02075255 ↗ “Subcutaneous Benralizumab (MEDI-563)” NCT02130882 ↗ “benralizumab (MEDI-563)” NCT02258542 ↗ “Benralizumab (Medi-563)” NCT03170271 ↗ |
| Action | Inhibit | “benralizumab, an investigational antiinterleukin 5 receptor α monoclonal antibody” PMID 25445859 ↗ Oct 2014 |
| Modality | Monoclonal antibody | “A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody” NCT00659659 ↗ |
| Route | Intravenous | “0.03 mg/kg intravenous injection” NCT00512486 ↗ |
| Target | IL5RA | “Anti-Interleukin-5 Receptor Alpha” NCT00659659 ↗ |