aclidinium
Trade name: tudorza pressair
Approved
Jul 23, 2012
Aclidinium is a long-acting, competitive, and reversible anticholinergic drug that is specific for the acetylcholine muscarinic receptors. It binds to all 5 muscarinic receptor subtypes to a similar affinity. It has a much higher propensity to bind to muscarinic receptors than nicotinic receptors. FDA approved on July 24, 2012. Aclidinium's effects on the airways are mediated through the M3 receptor at the smooth muscle to cause bronchodilation. Prevention of acetylcholine-induced bronchoconstriction effects was dose-dependent and lasted longer than 24 hours. — NCATS
Clinical trial activity
41 trials · 17 clinical orgs · 6 marketing orgs
Earliest trial started Jul 1, 2006 (NCT00363896)
Timeline
2000s
- Sep 30, 2003
Forest Laboratories — IND Organization
- Sep 30, 2003
Forest Laboratories — IND Organization
- Jan 1, 2006
AstraZeneca — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2008
AstraZeneca — Earliest Phase 2 Sponsor(trial)
2010s
- Jul 23, 2012
Forest Laboratories — Earliest FDA Approval
- Jul 23, 2012
AstraZeneca — NDA Secondary Org
- Jul 23, 2012
Covis — NDA Secondary Org
- Jul 23, 2012
Forest Laboratories — NDA Organization
- Jul 23, 2012
Circassia Limited — NDA Secondary Org
- Jul 23, 2012
Azurity — NDA Secondary Org
- Jan 1, 2018
AstraZeneca — Earliest Phase 1 Sponsor(trial)
- Mar 29, 2019
Advanz Pharma — NDA Secondary Org
Indications
Mechanism of action
- Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Indicated for COPD, M3 likely responsible
Combination products
duaklir pressair
with formoterol
Approval history
- approvedJul 23, 2012
Chemistry & pharmacology
SMILES
O=C(O[C@H]1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1- Mol. weight
- 484.66 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL1194325 ↗
- WikipediaAclidinium bromide ↗
- NCATSK17VY42F6C ↗
- ChEMBLCHEMBL551466 ↗
Also known as
- 14115700
- (3r)-3-((hydroxy(di-2-thienyl)acetyl)oxy)-1-(3-phenoxypropyl)-1-azoniabicyclo(2.2.2)octane bromide
- aclidininum bromide
- aclidinium
- aclidinium
- aclidinium
- aclidinium
- aclidinium
- aclidinium
- aclidinium
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide
- aclidinium bromide / formoterol fumarate dihydrate
- aclidinium bromide, micronised
- aclidinium / formoterol fumarate dihydrate
- eklira
- eklira
- las 34273
- las-34273
- las-34273
- las-34273 micronized
- las-34273 micronized
- las w-330
- las w-330
- las w-330
- tudorza pressair
- tudorza pressair
- tudorza pressair
- tudorza pressair
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03276052 | Phase 1 | Nov 16, 2018 | AstraZeneca, Jilin University |
| NCT03662711 | Phase 4 | Sep 30, 2018 | University of Ferrara |
| NCT03276078 | Phase 2 | Nov 23, 2017 | AstraZeneca, Jilin University |
| NCT03181880 | Phase 4 | Aug 25, 2017 | AstraZeneca, IQVIA |
| NCT03275116 | Phase 4 | Jul 7, 2017 | AstraZeneca, Maastricht University |
| NCT03104634 | Phase 3 | Apr 6, 2017 | McGill University |
| NCT03022097 | Phase 3 | Jan 24, 2017 | AstraZeneca, Parexel |
| NCT02972476 | Phase 4 | Dec 1, 2016 | AstraZeneca, University of Dundee |
| NCT02796677 | Phase 3 | Jul 5, 2016 | AstraZeneca |
| NCT02429765 | Phase 4 | Oct 1, 2015 | AstraZeneca, Queen's University, Belfast |
| NCT02424344 | Phase 4 | Apr 1, 2015 | AstraZeneca, Menarini Group |
| NCT02375724 | Phase 4 | Mar 1, 2015 | AstraZeneca, Menarini Group |
| NCT02181023 | Phase 4 | Jun 1, 2014 | University of Milan, University of Pavia |
| NCT02153489 | Phase 4 | Apr 1, 2014 | AstraZeneca |
| NCT02039050 | Phase 4 | Feb 1, 2014 | Almirall, University of Dundee |
| NCT02038829 | Phase 2 | Jan 1, 2014 | Sunovion |
| NCT01966107 | Phase 4 | Oct 16, 2013 | AstraZeneca, GlaxoSmithKline, Johns Hopkins University |
| NCT01908140 | Phase 3 | Sep 1, 2013 | AstraZeneca |
| NCT01636401 | Phase 3 | Aug 1, 2012 | Daewoong Pharmaceutical Co. LTD. |
| NCT01572792 | Phase 3 | Apr 1, 2012 | AstraZeneca |
Organizations
Research & Development (17)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 35 | 32 | 4 | 2006 |
| Jilin University | Academic/Hospital | 2 | 0 | 2 | 2017 |
| Menarini Group | For profit | 2 | 0 | 1 | 2015 |
| University of Dundee | Academic/Hospital | 2 | 2 | 1 | 2014 |
| Almirall | For profit | 1 | 0 | 1 | 2014 |
| Daewoong Pharmaceutical Co. LTD. | For profit | 1 | 1 | 1 | 2012 |
| GlaxoSmithKline | For profit | 1 | 0 | 1 | 2013 |
| IQVIA | For profit | 1 | 0 | 1 | 2017 |
| Johns Hopkins University | Academic/Hospital | 1 | 0 | 1 | 2013 |
| Maastricht University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| McGill University | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Parexel | For profit | 1 | 0 | 1 | 2017 |
| Queen's University, Belfast | Academic/Hospital | 1 | 1 | 1 | 2015 |
| Sunovion | For profit | 1 | 1 | 1 | 2014 |
| University of Ferrara | Academic/Hospital | 1 | 1 | 1 | 2018 |
| University of Milan | Academic/Hospital | 1 | 1 | 1 | 2014 |
| University of Pavia | Academic/Hospital | 1 | 0 | 1 | 2014 |
Marketing (8)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Advanz Pharma | For profit | NDA2 | Mar 29, 2019 |
| AstraZeneca | For profit | NDA2 | Jul 23, 2012 |
| AstraZeneca | For profit | SYN | Jul 23, 2012 |
| Azurity | For profit | NDA2 | Jul 23, 2012 |
| Circassia Limited | For profit | NDA2 | Jul 23, 2012 |
| Covis | For profit | NDA2 | Jul 23, 2012 |
| Forest Laboratories | For profit | NDA | Jul 23, 2012 |
| Forest Laboratories | For profit | IND | Sep 30, 2003 |