Drugs / Aclidinium
Aclidinium
also known as
Aclidinium Bromide · 14115700 · AB/FF · Aclidinium bromide component of duaklir pressair · Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) · Aclidinium cation · Aclidinium ion · Bretaris genuair · +10 more
Small molecule targets CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TUDORZA PRESSAIR | — | 2019-03-29 | fda.gov ↗ |
| Approved | US (FDA) | TUDORZA PRESSAIR | — | 2012-07-23 | fda.gov ↗ |
| Approved | EU (EMA) | Eklira Genuair | — | 2012-07-20 | europa.eu ↗ |
Trials 33 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03276052 | Oct → Nov 2021 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT03276078 | Nov 2017 → Jun 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01551888 | Jan → Mar 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01120093 | May → Aug 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01078623 | Feb → Sep 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01049360 | Dec 2009 → Aug 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00868231 | Mar → Jul 2009 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT00706914 | Jun → Nov 2008 | chronic obstructive pulmonary disease | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT00626522 | Feb → Nov 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT03104634 | May 2017 → Dec 2018 | — | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 3 | NCT03022097 | Feb 2017 → Apr 2022 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02796677 | Jul 2016 → Jun 2017 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01908140 | Sep 2013 → Aug 2014 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01462929 | Nov 2011 → Mar 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01471171 | Nov 2011 → Jun 2012 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01462942 | Oct 2011 → Jan 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01437540 | Sep 2011 → Mar 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01044459 | Nov 2009 → Apr 2011 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01001494 | Oct 2009 → Nov 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00970268 | Aug 2009 → Oct 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00891462 | Apr → Nov 2009 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01045161 | Mar 2009 → Jun 2011 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00500318 | Jul 2007 → Dec 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00435760 | Feb → Aug 2007 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00358436 | Aug 2006 → Jun 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00363896 | Jul 2006 → May 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT03662711 | Nov 2018 → Oct 2022 | chronic obstructive pulmonary disease | Università degli Studi di Ferrara | Terminated | No outcome recorded |
| Phase 4 | NCT02424344 | Apr 2015 → Jul 2016 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02375724 | Mar → Nov 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02181023 | Jun → Sep 2014 | chronic obstructive pulmonary disease | University of Milan | Completed | No outcome recorded |
| Phase 4 | NCT02153489 | Apr 2014 → Jun 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT02039050 | Feb 2014 → Jul 2015 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT01966107 | Oct 2013 → Sep 2017 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02038829 Comparator | Jan → May 2014 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02165826 Background | May 2014 → Sep 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01636401 Comparator | Aug 2012 → May 2013 | chronic obstructive pulmonary disease | Daewoong Pharmaceutical Co. LTD. | Completed | No outcome recorded |
| Phase 3 | NCT01572792 Comparator | Apr 2012 → Jun 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01437397 Comparator | Sep 2011 → Feb 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06282861 Comparator | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded |
| Phase 4 | NCT02972476 Comparator | Dec 2016 → Jul 2019 | chronic obstructive pulmonary disease | University of Dundee | Completed | No outcome recorded |
| Phase 4 | NCT02429765 Comparator | Oct 2015 → Aug 2018 | chronic obstructive pulmonary disease | Queen's University | Completed | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 45 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aclidinium | “Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics:...” NCT02165826 ↗25“formoterol [a long-acting beta2-agonist (LABA)] and aclidinium bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]” NCT02429765 ↗ “BACKGROUND AND OBJECTIVE: Aclidinium bromide ('aclidinium') is a novel, inhaled long-acting muscarinic antagonist.” PMID 26370136 ↗ Sep 2015 “patients were randomised to inhaled aclidinium 200 μg or placebo once-daily.” PMID 21518460 ↗ Apr 2011 “Aclidinium” NCT03662711 ↗ |
| Known as | 14115700 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | AB/FF | “Aclidinium bromide/formoterol fumarate (AB/FF) 400/12 μg efficacy and safety was demonstrated in two 6-month Phase III studies (AUGMENT and ACLIFORM) and a 12-month study in...” PMID 28340861 ↗ Feb 2017 |
| Known as | Aclidinium Bromide | “Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry” NCT02039050 ↗21“formoterol [a long-acting beta2-agonist (LABA)] and aclidinium bromide [a long-acting muscarinic antagonist (LAMA) or anticholinergic]” NCT02429765 ↗ “Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days” NCT01120093 ↗ “Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler” NCT02424344 ↗ “Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira)” NCT02181023 ↗ “Inhaled Aclidinium bromide 400 μg, twice per day” NCT01572792 ↗ |
| Known as | Aclidinium bromide component of duaklir pressair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01572792 ↗ |
| Known as | Aclidinium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Aclidinium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Bretaris genuair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Bromure d'aclidinium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Bromuro de aclidinio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Eklira | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06282861 ↗ |
| Known as | Eklira genuair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | Genuai | “METHODS: A total of 263 Korean patients with moderate-to-severe COPD were randomized to receive aclidinium (400 μg, bd) (Genuai) or placebo via a dry-powder inhaler.” PMID 26370136 ↗ Sep 2015 |
| Known as | Genuair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | LAS 34273 MICRONIZED | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | LAS W-330 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Known as | LAS34273 | “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance...” NCT00500318 ↗ |
| Known as | Tudorza pressair | ChEMBL registry synonym — accepted as the source's own label CHEMBL1194325 ↗ |
| Action | Inhibit | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1194325 ↗1“a novel, long-acting muscarinic antagonist” PMID 21518460 ↗ Apr 2011 |
| Modality | Other / unclassified | “a novel, long-acting muscarinic antagonist” PMID 21518460 ↗ Apr 2011 |
| Modality | Small molecule | — CHEMBL1194325 ↗ |
| Route | Inhaled | “Aclidinium bromide 200 μg once-daily via inhalation” NCT00358436 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1194325 ↗ |