Aclidinium
As of the edition of 20 October 2026, Aclidinium is a small molecule: marketed, first approved in 2012 (EU); acts on CHRM3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Tudorza Pressair
- First approved
- 20 July 2012 (EU)
- Approvals on record
- 8 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 3 holders in all
- Registered trials
- 35, 1 stopped early
- Disease areas
- Lungs and airways; Infections; Immune system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Aclidinium.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CHRM3 | Muscarinic acetylcholine receptor M3 | P20309 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 8 | 7 | 0 | 1 |
| Phase 3 | 18 | 18 | 0 | 0 |
| Phase 4 | 6 | 6 | 0 | 0 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Covis Pharma | Applicant | 2012 to now |
| Actavis | Applicant | 2012 to now |
| Kyorin Pharmaceutical | Applicant | 2015 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |