Drugs / Benralizumab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 3 milestones | |||||
| Filed | EU (EMA) | — | asthma | 2017-05-10 | “benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan” astrazeneca.com ↗ |
| Filed | US (FDA) | — | asthma | 2017-05-10 | “benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan” astrazeneca.com ↗ |
| Filed | Japan (PMDA) | — | asthma | 2017-05-10 | “benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan” astrazeneca.com ↗ |
| Rejected bronchiectasis and nasal polyposis 1 milestone | |||||
| Rejected (CRL) | US (FDA) | Fasenra | bronchiectasis and nasal polyposis | 2022-03-14 | “The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab)” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 ↗ |
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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 · 1 met primary · 5 missed | ||||||
| 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| Phase 2 | NCT05528913 | Oct 2023 | prurigo | Charite University, Berlin, Germany | Withdrawn | No outcome recorded Stop: Business |
| 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 | Missed primary |
| Phase 2 | NCT04098718 | Mar 2021 → Feb 2024 | asthma, chronic obstructive pulmonary disease | University of Oxford | Unknown | Met primary |
| Phase 2 | NCT04605094 | Nov 2020 → Apr 2022 | atopic eczema | AstraZeneca | Terminated | Missed primary |
| Phase 2 | NCT04612725 | Oct 2020 → Oct 2022 | chronic urticaria | AstraZeneca | Terminated | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT00768079 | Feb 2009 → Dec 2010 | asthma | MedImmune LLC | Completed | Missed primary |
| Phase 2 | NCT00783289 | Nov 2008 → Nov 2009 | asthma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03473977 | Apr 2018 → Jun 2020 | eosinophilic gastrointestinal disease | Children's Hospital Medical Center, Cincinnati | Completed | Met primary |
| Phase 333 trials · 8 met primary · 7 missed | ||||||
| Phase 3 | NCT07444567 | Jul 2026 → Dec 2029 expected | asthma, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome | AstraZeneca | 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 | chronic asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT05692180 | Apr 2023 → Dec 2026 expected | asthma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05251909 | Jan 2022 → Feb 2024 | eosinophilic gastritis | AstraZeneca | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT05006573 | Jul 2021 → Apr 2024 | bronchiectasis | AstraZeneca | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT04612790 | Mar 2021 → Oct 2023 | bullous pemphigoid | AstraZeneca | Terminated | Missed primary |
| Phase 3 | NCT04543409 | Sep 2020 → Sep 2022 | eosinophilic esophagitis | AstraZeneca | Terminated | Mixed |
| Phase 3 | NCT04191304 | Jul 2020 → May 2025 overdue | hypereosinophilic syndrome | AstraZeneca | Active not recruiting | Met primary |
| 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 | Missed primary |
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT03186209 | Sep 2017 → Jan 2023 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT03170271 | Jul 2017 → Sep 2019 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02918071 | Nov 2016 → Aug 2017 | asthma | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02869438 | Nov 2016 → Aug 2018 | asthma | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02821416 | Oct 2016 → Oct 2019 | asthma | AstraZeneca | Completed | Mixed |
| 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 | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT02138916 | Jun 2014 → Apr 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT02075255 | Apr 2014 → Aug 2016 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01947946 | Nov 2013 → Jul 2014 | asthma | AstraZeneca | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01928771 | Sep 2013 → Apr 2016 | asthma | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01914757 | Aug 2013 → Mar 2016 | asthma | AstraZeneca | Completed | Met primary |
| Phase 410 trials | ||||||
| Phase 4 | NCT07654842 | Jul 2026 → Sep 2027 expected | asthma | Endeavor Health | Enrolling by invitation | 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 |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT00512486 Comparator | Nov 2006 → Sep 2008 | asthma | MedImmune LLC | Completed | No outcome recorded |
| 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 2/3 | NCT02130882 Comparator | May 2014 → Jun 2020 | hypereosinophilic syndrome, respiratory system disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Unknown | No outcome recorded |
| Phase 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 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 |
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2025-09-17 | AstraZeneca | Results Update on the RESOLUTE Phase III trial for Fasenra in chronic obstructive pulmonary disease astrazeneca.com ↗
The RESOLUTE Phase III trial of AstraZeneca’s Fasenra (benralizumab), despite showing numerical improvement, did not achieve statistical significance in the primary endpoint in patients with chronic obstructive pulmonary disease (COPD). |
| 2024-10-28 | AstraZeneca | Regulatory Fasenra approved in the EU for eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗
AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). |
| 2024-09-23 | AstraZeneca | Regulatory Fasenra recommended for approval in the EU by CHMP for the treatment of eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗
AstraZeneca’s Fasenra (benralizumab) has been recommended for approval in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). |
| 2024-09-18 | AstraZeneca | Regulatory Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis astrazeneca.com ↗
AstraZeneca’s Fasenra (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). |
| 2024-08-20 | AstraZeneca | Regulatory Fasenra approved in China for the treatment of severe eosinophilic asthma astrazeneca.com ↗ |
| 2024-05-01 | AstraZeneca | Results AstraZeneca unveils latest research across key respiratory and immune-mediated diseases at ATS 2024 showcasing strength of its broad pipeline and portfolio astrazeneca.com ↗
A highlight of the MANDARA data is the impact of Fasenra (benralizumab) to reduce or completely eliminate oral glucocorticoid use in these patients. |
| 2023-09-11 | AstraZeneca | Results Fasenra met the primary endpoint in the MANDARA Phase III trial in eosinophilic granulomatosis with polyangiitis (EGPA) astrazeneca.com ↗ |
| 2023-08-29 | AstraZeneca | Results AstraZeneca data at ERS 2023 demonstrate leadership in transforming care across a broad respiratory portfolio of inhaled and biologic medicines astrazeneca.com ↗
High-level results from the trial demonstrated a clinically and statistically significant reduction in asthma exacerbation rate. |
| 2022-10-25 | AstraZeneca | Results Update on the MESSINA Phase III trial for Fasenra in eosinophilic esophagitis astrazeneca.com ↗
High-level results from the MESSINA Phase III trial showed that AstraZeneca's Fasenra (benralizumab) did not meet one of the two dual-primary endpoints. |
| 2022-03-14 | AstraZeneca | Regulatory Update on US regulatory review of Fasenra in chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Fasenra (benralizumab) for patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). |
| 2020-10-29 | AstraZeneca | Results Fasenra eliminated oral corticosteroid use in a majority of OCS-dependent patients with asthma in PONENTE Phase IIIb trial astrazeneca.com ↗
High-level results from the PONENTE Phase IIIb open-label trial showed Fasenra (benralizumab) eliminated the use of maintenance oral corticosteroids (OCS) in OCS-dependent asthma patients with a broad range of blood eosinophil counts. |
| 2020-09-10 | AstraZeneca | Results Fasenra met both co-primary endpoints of reduced nasal polyp size and blockage in the OSTRO Phase III trial for patients with chronic rhinosinusitis with nasal polyps astrazeneca.com ↗
High-level results from the OSTRO Phase III trial showed AstraZeneca’s Fasenra (benralizumab) compared with placebo demonstrated a statistically significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). |
| 2019-10-04 | AstraZeneca | Regulatory Fasenra approved in the US for self-administration in a new pre-filled auto-injector, the Fasenra Pen astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen ). |
| 2019-09-25 | AstraZeneca | Results AstraZeneca to present next wave of science in respiratory disease at ERS International Congress astrazeneca.com ↗
In biologics, highlights will include a new analysis of the Phase III GALATHEA and TERRANOVA trials for Fasenra (benralizumab), a potential treatment in COPD, which identifies the clinical characteristics of COPD patients who may benefit from Fasenra. |
| 2019-08-28 | AstraZeneca | Regulatory Fasenra granted US Orphan Drug Designation for eosinophilic oesophagitis astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE). |
| 2019-07-01 | AstraZeneca | Regulatory Fasenra receives positive EU CHMP opinion for self-administration and the new Fasenra pen, a pre-filled, single-use auto-injector astrazeneca.com ↗
The CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation. |
| 2019-04-04 | AstraZeneca | Results Positive results from Fasenra Phase II trial in hypereosinophilic syndrome published in New England Journal of Medicine astrazeneca.com ↗
A Phase II trial has demonstrated that Fasenra (benralizumab) can achieve near-complete depletion of eosinophils and improve clinical outcomes in hypereosinophilic syndrome (HES). |
| 2019-02-06 | AstraZeneca | Regulatory US FDA grants Fasenra Orphan Drug Designation for hypereosinophilic syndrome astrazeneca.com ↗
The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome (HES). |
| 2018-11-26 | AstraZeneca | Regulatory US FDA grants Fasenra Orphan Drug Designation for Eosinophilic Granulomatosis with Polyangiitis astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA). |
| 2018-11-19 | PharmaLundensis AB | Results Problem för konkurrenters nya KOL-behandlingar pharmalundensis.se ↗
AstraZenecas nya KOL-substans Fasenra (benralizumab) misslyckades helt att påvisa någon som helst statisk förbättring . |
| 2018-09-18 | AstraZeneca | Results Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma astrazeneca.com ↗
In the BORA trial, Fasenra given for an additional 56 weeks showed a safety and tolerability profile similar to that observed in the placebo-controlled SIROCCO and CALIMA trials, with no increase in the frequencies of overall or serious adverse events. |
| 2018-05-30 | AstraZeneca | Results Update on TERRANOVA Phase III trial for Fasenra in chronic obstructive pulmonary disease astrazeneca.com ↗
The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations. |
| 2018-05-11 | AstraZeneca | Results AstraZeneca provides update on GALATHEA Phase III trial for Fasenra in chronic obstructive pulmonary disease astrazeneca.com ↗
The trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with COPD. |
| 2018-01-19 | AstraZeneca | Regulatory Fasenra receives approval in Japan astrazeneca.com ↗
Fasenra is the first approved respiratory biologic with an 8-week maintenance dosing schedule |
| 2018-01-10 | AstraZeneca | Regulatory AstraZeneca receives EU approval of Fasenra for severe eosinophilic asthma astrazeneca.com ↗
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists. |
| 2017-11-14 | AstraZeneca | Regulatory Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma astrazeneca.com ↗ |
| 2017-11-10 | AstraZeneca | Regulatory Benralizumab receives positive EU CHMP opinion for severe, uncontrolled eosinophilic asthma astrazeneca.com ↗ |
| 2017-09-11 | AstraZeneca | Results AstraZeneca presents new results identifying severe asthma patients who would benefit most from benralizumab astrazeneca.com ↗
AstraZeneca today announced results from a subgroup analysis of the SIROCCO and CALIMA Phase III trials. |
| 2017-05-22 | AstraZeneca | Results Phase III ZONDA trial for benralizumab shows ability to reduce oral steroid use in severe asthma patients astrazeneca.com ↗
The trial achieved its primary efficacy endpoint, demonstrating statistically-significant and clinically relevant reduction in daily maintenance OCS use with two benralizumab dosing regimens compared with placebo. |
| 2017-05-18 | AstraZeneca | Results AstraZeneca to present scientific advancements from growing respiratory portfolio at the American Thoracic Society conference 2017 astrazeneca.com ↗
Phase III ZONDA trial shows the potential of benralizumab to reduce or discontinue the use of oral corticosteroids |
| 2016-09-05 | AstraZeneca | Results Benralizumab phase III trials show positive results in severe asthma astrazeneca.com ↗
The outcomes were demonstrated for the 8-week dosing regimen, with no additional benefit observed with 4-week dosing, which may support less-frequent dosing. |
| 2016-05-17 | Kyowa Kirin, Inc. | Results Top-Line Results from the Benralizumab Phase III Programme in Severe Asthma kyowakirin.com ↗
We are delighted with the positive results from these pivotal Phase III studies of benralizumab in patients with uncontrolled asthma. |
| 2016-05-17 | AstraZeneca | Results AstraZeneca announces positive results from benralizumab phase III programme in severe asthma astrazeneca.com ↗
AstraZeneca today announced that benralizumab, a potential new medicine and anti-eosinophil monoclonal antibody, was well tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo. |
| 2016-05-12 | AstraZeneca | Results AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference astrazeneca.com ↗
High blood eosinophil concentrations and serum biomarkers of low IL-13 pathway activation at baseline predict exacerbation rate reduction by benralizumab for patients with moderate to severe asthma |
| 2014-10-09 | AstraZeneca | Results Positive results from Phase IIb benralizumab study in severe asthma published in The Lancet Respiratory Medicine astrazeneca.com ↗
The study met the primary endpoint, with patients taking benralizumab experiencing a statistically significant reduction in their asthma exacerbation rate versus subjects taking placebo over a period of one year. |
| 2014-09-08 | AstraZeneca | Results Benralizumab Phase II COPD study published in The Lancet Respiratory Medicine astrazeneca.com ↗
The primary endpoint in the study was not met, as benralizumab did not reduce the acute exacerbation rate compared with placebo in the overall patient population. |
| 2014-05-15 | AstraZeneca | Results Continuing progress in accelerating late stage pipeline reinforces confidence in AstraZeneca’s strategy as an independent company astrazeneca.com ↗
Both showed improvement in key measures of asthma control for patients with specific, severe forms of asthma. |
| 2014-05-12 | AstraZeneca | Results AstraZeneca to present respiratory data at ATS 2014 International Conference astrazeneca.com ↗
In the Phase IIb data being presented, both benralizumab and tralokinumab show promising safety and efficacy outcomes, suggesting they may offer important new therapeutic options for patients with specific forms of severe, uncontrolled asthma. |
All press releases naming this drug 47 releases
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 ↗ |
| 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 ↗ “Benralizumab (Medi563) Administered subcutaneously” NCT03170271 ↗ “Subcutaneous Benralizumab (MEDI-563)” NCT02130882 ↗ “benralizumab (MEDI-563)” NCT02258542 ↗ |
| 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 ↗ |