Drugs / Aclidinium
Aclidinium
also known as
Aclidinium bromide · AB/FF · Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) · Genuai · LAS34273
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 2 milestones | |||||
| Filed | EU (EMA) | — | chronic obstructive pulmonary disease | 2013-11-04 | “submission of the Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for the fixed combination of aclidinium bromide (LAMA) and formoterol fumarate” almirall.com ↗ “Aclidinium, a new therapeutic option coming from Almirall's respiratory R&D, was filed for registration in the US and Europe in 2011” almirall.com ↗ “Aclidinium bromide monotherapy submitted for approval in EU and US” almirall.com ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | — | “Aclidinium, a new therapeutic option coming from Almirall's respiratory R&D, was filed for registration in the US and Europe in 2011” almirall.com ↗ “Aclidinium bromide monotherapy submitted for approval in EU and US” almirall.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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
| 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 · 5 met primary | ||||||
| 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 | Met primary |
| Phase 2 | NCT01078623 | Feb → Sep 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT01049360 | Dec 2009 → Aug 2010 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 2 | NCT00868231 | Mar → Jul 2009 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 317 trials · 9 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT02796677 | Jul 2016 → Jun 2017 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01908140 | Sep 2013 → Aug 2014 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01462942 | Oct 2011 → Jan 2013 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01045161 | Mar 2009 → Jun 2011 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00500318 | Jul 2007 → Dec 2008 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 47 trials · 1 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT02375724 | Mar → Nov 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Met primary |
| 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 |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT02038829 Comparator | Jan → May 2014 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | Met primary |
| Phase 3 | NCT02165826 Background | May 2014 → Sep 2015 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Mixed |
| 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 | Mixed |
| 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 |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2022-10-25 | Covis Pharma S.à.r.l. | Results Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD covispharma.com ↗
Covis Pharma Group (“Covis”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, today announced positive topline results from the AVANT phase 3 clinical trial for Duaklir ® (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira ® (aclidinium bromide 400µg twice-daily) |
| 2018-08-13 | Niox | Regulatory Circassia Announces Duaklir® New Drug Application (NDA) and Tudorza® Supplemental NDA Accepted for Review by FDA niox.com ↗
The FDA has also accepted for review the Tudorza® supplemental NDA (sNDA) requesting the inclusion of new clinical data demonstrating cardiovascular safety and the reduction of COPD exacerbations in the product’s prescribing information. |
| 2018-06-01 | Niox | Regulatory Circassia Announces Submission of Duaklir® New Drug Application and Tudorza® Supplemental New Drug Application in the United States niox.com ↗
Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Duaklir® Pressair® for the treatment of chronic obstructive pulmonary disease (COPD). |
| 2018-05-22 | Niox | Results Circassia Announces Positive Data Presented at 2018 American Thoracic Society Conference from Tudorza® Phase IV and Duaklir® Phase III Studies niox.com ↗ |
| 2017-12-04 | AstraZeneca | Results Tudorza reduces exacerbations and demonstrates cardiovascular safety in COPD patients astrazeneca.com ↗
When added to background therapy, Tudorza met the primary efficacy endpoint, demonstrating a statistically significant reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo. |
| 2017-12-04 | Almirall, S.A. | Results Phase IV ASCENT trial shows Tudorza reduces COPD exacerbations and demonstrates cardiovascular safety almirall.com ↗
Barcelona, December 4th 2017 Almirall, S.A (ALM) , today announced positive top-line results from the Phase IV, ASCENT trial for Tudorza (aclidinium bromide 400μg, twice-daily), a long-acting muscarinic antagonist (LAMA). |
| 2017-12-04 | Niox | Results Circassia Announces Tudorza® Successfully Met Both Primary Endpoints in ASCENT Phase IV Study in Chronic Obstructive Pulmonary Disease niox.com ↗
The ASCENT study met its primary efficacy endpoint, with Tudorza® demonstrating statistically significant reductions in the rate of moderate or severe COPD exacerbations compared with placebo. |
| 2017-09-07 | AstraZeneca | Results Duaklir significantly improves lung function in COPD patients astrazeneca.com ↗
In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily. |
| 2017-09-07 | Almirall, S.A. | Results Phase III AMPLIFY study shows Duaklir significantly improves lung function in moderate to very severe stable COPD almirall.com ↗
In comparison to tiotropium bromide 18µg once-daily, both Duaklir and aclidinium bromide monotherapy demonstrated significantly higher levels of bronchodilation during the night-time, whilst aclidinium bromide monotherapy showed non-inferior bronchodilation to tiotropium over 24 weeks. |
| 2017-09-07 | Niox | Results Circassia Announces Duaklir® Successfully Met Primary Endpoints in AMPLIFY Phase III Study in Chronic Obstructive Pulmonary Disease niox.com ↗ |
| 2016-08-30 | AstraZeneca | Results AstraZeneca to present new data highlighting its growing respiratory portfolio and pipeline at European Respiratory Society 2016 astrazeneca.com ↗
A Duaklir (aclidinium/formoterol) study showing reduced deterioration in COPD compared to monotherapies and placebo (abstract #PA301) |
| 2016-05-12 | AstraZeneca | Results AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference astrazeneca.com ↗
Improvement in lung function and symptom control with aclidinium bromide versus tiotropium and placebo in symptomatic patients with COPD: post-hoc analysis of a Phase IIIb study |
| 2014-09-25 | Almirall, S.A. | Regulatory Almirall's aclidinium bromide/formoterol fumarate recommended for approval in Europe to treat COPD almirall.com ↗ |
| 2013-11-04 | Almirall, S.A. | Regulatory Aclidinium and formoterol fixed dose combination for COPD submitted for registration in Europe almirall.com ↗ |
| 2013-05-02 | Almirall, S.A. | Results Almirall and Forest Laboratories announce positive results for the second Phase III study for aclidinium and formoterol combination in COPD almirall.com ↗
The 400/6mcg combination demonstrated statistically significant improvements in (FEV1) at 1 hour post-dose versus aclidinium 400mcg (p<0.0001). |
| 2013-04-16 | Almirall, S.A. | Results Almirall and Forest Laboratories announce positive results of a Phase III Study for aclidinium and formoterol combination in COPD almirall.com ↗ |
| 2012-09-20 | Almirall, S.A. | Regulatory Almirall launches Eklira® Genuair® (aclidinium) in Europe almirall.com ↗
Almirall, S.A. (ALM:MC) announced that the Danish Health and Medicines Authority has granted general reimbursement to Eklira ® Genuair ® (aclidinium 322µg twice daily), as a maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adult patients, following the positive recommendation by the Danish Reimbursement Committee and the marketing approval from the European Commission. |
| 2012-09-03 | Almirall, S.A. | Results Eklira® Genuair® provides meaningful and sustained bronchodilation from the first dose. Patients prefer the Genuair® inhaler over HandiHaler® almirall.com ↗
In the study, aclidinium met the primary endpoint (change from baseline in normalized FEV 1 AUC 0-24h at 6- weeks) showing a clinically meaningful and statistically significant improvement (p<0.0001) vs placebo. |
| 2012-07-24 | Almirall, S.A. | Regulatory Eklira®/Bretaris® Genuair® (aclidinium bromide) approved in Europe for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) almirall.com ↗ |
| 2012-07-24 | Almirall, S.A. | Regulatory Almirall and Forest Laboratories announce FDA approval of Tudorza™ Pressair™ for the long-term maintenance treatment of COPD almirall.com ↗ |
| 2012-05-28 | Almirall, S.A. | Regulatory Almirall's aclidinium recommended for approval in Europe to treat COPD almirall.com ↗
Positive CHMP opinion is an important step in making this new respiratory therapy available to treat Chronic Obstructive Pulmonary Disease (COPD) |
| 2012-03-29 | Almirall, S.A. | Regulatory Almirall and Forest Laboratories announce FDA has extended the review period for Aclidinium Bromide almirall.com ↗ |
| 2012-03-22 | Almirall, S.A. | Results Aclidinium clinical data published in the European Respiratory Journal confirms efficacy and safety of this new treatment for COPD patients almirall.com ↗
Significant improvement from baseline was observed with aclidinium 200 µg and 400 µg versus placebo for trough FEV1 (99 and 128 mL; both p<0.0001). |
| 2012-02-24 | Almirall, S.A. | Regulatory Almirall and Forest Announce Positive FDA Advisory Committee’s Recommendation for Approval of Aclidinium Bromide for the Treatment of Chronic Obstructive Pulmonary Disease (COPD) almirall.com ↗ |
| 2011-09-27 | Almirall, S.A. | Results COPD patients experienced benefits from the first dose when treated with aclidinium, as shown in the ATTAIN Phase III study almirall.com ↗
Aclidinium demonstrates improved lung function, symptom control and quality of life for Chronic Obstructive Pulmonary Disease ( COPD) patients |
| 2011-07-27 | Almirall, S.A. | Regulatory Aclidinium bromide submitted for registration in Europe almirall.com ↗ |
| 2011-01-04 | Almirall, S.A. | Results Almirall and Forest announce positive results from the ATTAIN Phase III study of aclidinium bromide and the Phase IIb studies with the fixed dose combination with formoterol in moderate to severe COPD patients almirall.com ↗
ATTAIN results confirm clinically significant bronchodilation and improvement of symptoms in COPD patients treated with aclidinium bromide twice daily (BID) |
| 2010-10-29 | Almirall, S.A. | Results Almirall and Forest report preliminary topline results from the ACCORD COPD II Phase III study of aclidinium bromide in Chronic Obstructive Pulmonary Disease (COPD) almirall.com ↗
Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. (NYSE: FRX) today announced top-line results from ACCORD COPD II, a 12-week Phase III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD. |
| 2010-01-07 | Almirall, S.A. | Results Almirall and Forest announce positive results from the ACCORD COPD I Phase III study of aclidinium bromide in Chronic Obstructive Pulmonary Disease (COPD) almirall.com ↗
Top line results of ACCORD COPD I, the first three-month Phase III pivotal study with aclidinium twice daily (BID) in patients with COPD, met primary endpoint [1] . |
| 2009-10-20 | Almirall, S.A. | Results Update on Eklira® (aclidinium bromide) for chronic obstructive pulmonary disease (COPD): Positive results in a short-term comparative trial and announcement of new Phase III studies almirall.com ↗
The positive outcomes from a short-term Phase II comparative study with Eklira ® BID vs tiotropium and placebo 1 , confirm Almirall and Forest decision to add to the ongoing twice daily development programme |
| 2009-09-09 | Almirall, S.A. | Results Almirall aims to file once daily aclidinium bromide for COPD in Europe in early 2010 almirall.com ↗
In two 12-month Phase III studies aclidinium bromide showed a consistent and sustained improvement in pulmonary function together with improved symptom control and quality of life in patients with chronic obstructive pulmonary disease (COPD) |
| 2008-09-03 | Almirall, S.A. | Results Phase III clinical studies of aclidinium bromide show statistical significance vs. placebo in patients with chronic obstructive pulmonary disease (COPD) almirall.com ↗
In both studies aclidinium therapy demonstrated a significant difference vs placebo in trough FEV1 at 12 week (p-value 0.001) and 28 weeks (p-value 0.001). |
| 2008-05-20 | Almirall, S.A. | Results Almirall and Forest Laboratories Announce Positive Results of Clinical Studies for Aclidinium Bromide, A Novel Long-Acting Anticholinergic for the Treatment for COPD almirall.com ↗ |
| 2007-09-18 | Almirall, S.A. | Results Aclidinium bromide demonstrates rapid and long-acting bronchodilatory effect in COPD almirall.com ↗
In the phase IIa trial, single doses of inhaled aclidinium produced a significant bronchodilatory response in patients with COPD. |
| 2005-06-27 | Almirall, S.A. | Results Almirall reveals promising phase II data with its once-daily, long-acting, low systemic exposure, inhaled anticholinergic LAS34273 almirall.com ↗
Results demonstrate that LAS34273 has a sustained 24-h bronchodilator effect; an effect that was rapidly observed and was maintained over the 4 weeks of the trial, indicating absence of tachiphylaxis. |
All press releases naming this drug 49 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 43 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 | 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/formoterol Fixed-Dose Combination (FDC) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01572792 ↗ |
| 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 | 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 ↗ |
| Action | Inhibit | “a novel, long-acting muscarinic antagonist” PMID 21518460 ↗ Apr 2011 |
| Modality | Other / unclassified | “a novel, long-acting muscarinic antagonist” PMID 21518460 ↗ Apr 2011 |
| Route | Inhaled | “Aclidinium bromide 200 μg once-daily via inhalation” NCT00358436 ↗ |