Vilanterol
As of the edition of 20 October 2026, Vilanterol is a small molecule: marketed, first approved in 2013 (US); acts on ADRB2; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Breo Ellipta
- First approved
- 10 May 2013 (US)
- Approvals on record
- 25 in 5 regions
- Holder of the most recent approval
- GSK; 4 holders in all
- Withdrawn from market
- 14 June 2022 (in some regions)
- Registered trials
- 89, 4 stopped early
- Disease areas
- Lungs and airways; Immune system; Heart and blood vessels; Infections; Cancer; Pregnancy and women's health
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADRB2 | Beta-2 adrenergic receptor | P07550 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 3 | 2 | 0 |
| Phase 1 | 18 | 18 | 0 | 0 |
| Phase 2 | 10 | 10 | 0 | 0 |
| Phase 3 | 45 | 42 | 1 | 2 |
| Phase 4 | 10 | 5 | 2 | 2 |
| All trials | 89 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 2005 to now |