Umeclidinium
As of the edition of 20 October 2026, Umeclidinium is a small molecule: marketed, first approved in 2013 (US); acts on CHRM3; US protection ends in 2027.
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
- Anoro Ellipta
- First approved
- 18 December 2013 (US)
- Approvals on record
- 22 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- Withdrawn from market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
- 53, 2 stopped early
- Disease areas
- Lungs and airways; Immune system; Infections; Skin and connective tissue; Cancer; Heart and blood vessels
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by GSK.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRM3 | Muscarinic acetylcholine receptor M3 | P20309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 9 | 9 | 0 | 0 |
| Phase 2 | 10 | 9 | 1 | 0 |
| Phase 3 | 24 | 22 | 1 | 1 |
| Phase 4 | 7 | 3 | 2 | 1 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 2007 to now |