Treats severe asthma, and with an eosinophilic phenotype. Sold as Fasenra. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Benralizumab (sold as Fasenra), first approved Nov 14, 2017, with 4 new uses approved and 0 published complete response letters.
| Fasenra Pen | Part D | $387M | +67% | 13,688 |
| Fasenra | Part B | $251M | +4% | 10,424 |
| Fasenra | Part D | $96.7M | +27% | 3,756 |
| T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPDAsthma, COPD (Chronic Obstructive Pulmonary Disease) · Shanghai Pulmonary Hospital, Shanghai, China | — | Recruiting | Sep 16, 2026 |
| Benralizumab Effectiveness in EGPAEosinophilic Granulomatosis With Polyangiitis (EGPA) · European EGPA Study Group | — | Recruiting | Sep 11, 2026 |
| Fasenra: An Asthma StudyEosinophilic Asthma, Severe Asthma · Endeavor Health | Phase 4 | Enrolling by invitation | Jun 17, 2026 |
| Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With BiologicsSevere Eosinophilic ACOS (Asthma-COPD Overlap) · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | — | Not yet recruiting | May 22, 2026 |
| Real-World Effectiveness of Benralizumab in Allergic Bronchopulmonary AspergillosisAllergic Bronchopulmonary Aspergillosis, Severe Asthma · Qianfoshan Hospital | — | Recruiting | Apr 15, 2026 |
| Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued TreatmentAsthma, Eosinophilic Granulomatosis With Polyangiitis (EGPA) · AstraZeneca | Phase 3 | Recruiting | Mar 3, 2026 |
| Characterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B)Severe Asthma · AstraZeneca | — | Active, not recruiting | Oct 20, 2025 |
| A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab in ItalySevere Eosinophilic Asthma · AstraZeneca | — | Recruiting | Oct 9, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 14, 2017 | FasenraBLA 761070 · New molecular entity | Astrazeneca AB | 4 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Astrazeneca AB