Benralizumab
As of the edition of 20 October 2026, Benralizumab is an antibody: marketed, first approved in 2017 (US); acts on IL5RA; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Fasenra
- First approved
- 14 November 2017 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 74, 11 stopped early
- Disease areas
- Immune system; Lungs and airways; Blood and lymph; Skin and connective tissue; Heart and blood vessels; Digestive system
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). The application that gives this date is held by AstraZeneca.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Target
| Gene | Protein | UniProt |
|---|---|---|
| IL5RA | Interleukin-5 receptor subunit alpha | Q01344 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 4 | 5 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 15 | 7 | 2 | 4 |
| Phase 3 | 33 | 22 | 5 | 6 |
| Phase 4 | 11 | 5 | 3 | 1 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2008 to now |