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Drug

Aclidinium bromide

Approved · EMA

Late-stage development

Also known as Duaklir, Tudorza.

2

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Clinical trial2025-03-26Results posted · ClinicalTrials.gov

A Phase I, Open-Label, Single and Multiple Dose (Twice-Daily), Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation in Healthy Chinese Participants

Clinical trial2023-12-11Results posted · ClinicalTrials.gov

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

Clinical trial2018-12-06Results posted · ClinicalTrials.gov

A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Clinical trial2018-11-09Results posted · ClinicalTrials.gov

A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

Clinical trial2017-04-21Results posted · ClinicalTrials.gov

A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD

Clinical trial2017-04-21Results posted · ClinicalTrials.gov

A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

Clinical trial2017-04-20Results posted · ClinicalTrials.gov

A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD).

Clinical trial2017-03-23Results posted · ClinicalTrials.gov

Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

Clinical trial2017-02-15Results posted · ClinicalTrials.gov

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

Clinical trial2017-01-23Results posted · ClinicalTrials.gov

Approval: Bretaris Genuair (EMA)

Regulatory2012-07-20EMA

Approval: Eklira Genuair (EMA)

Regulatory2012-07-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Aclidinium bromide

Aliases & brands

DuaklirTudorza

RxNorm CUI

1303097

Regulatory jurisdictions

ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2012-07-20

Latest approval

2012-07-20

Authorities

EMA

Total events

2

emaEuropean Medicines Agency· 2 events

2012-07-20Approval

Approval: Eklira Genuair (EMA)

Indication: Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

2012-07-20Approval

Approval: Bretaris Genuair (EMA)

Indication: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

21 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

21

registered trials across all phases

LATEST COMPLETION 2022

20

Late-stage (III+)

21

Completed

PHASE DISTRIBUTIONn = 21

Phase 11Phase 316Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

CompletedPH IVKey trialAstraZenecan=3,6352017

A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD

CompletedPH IVAstraZenecan=3002015

A Pilot, Double-blind, Placebo-controlled, 2-period Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

CompletedPH IVAstraZenecan=302015

Acute Effect of Aclidinium on Hyperinflation and Lung Volume Distribution in Severe COPD Patients

CompletedPH IVUniversity of Milann=372014

A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

CompletedPH IIIKey trialAstraZenecan=1,6252022

Recent completions

Trials that read out recently, adding to the completed evidence base.

A 24-week Treatment, Randomised, Parallel-group, Double Blinded, Double-Dummy, Multicenter Study to Assess the Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Compared With Individual Components and Placebo and Aclidinium Bromide Compared With Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

CompletedPH IIIKey trialAstraZenecan=1,6252022

A Phase I, Open-Label, Single and Multiple Dose (Twice-Daily), Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide 400 μg Administered by Inhalation in Healthy Chinese Participants

CompletedPH IAstraZenecan=202021

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

CompletedPH IVKey trialAstraZenecan=3,6352017

A 24 Week Treatment, Multicenter, Randomized, Double Blinded, Double Dummy, Parallel-group, Clinical Trial Evaluating the Efficacy and Safety of Aclidinium Bromide 400 μg/Formoterol Fumarate 12 μg Fixed-dose Combination BID Compared With Each Monotherapy (Aclidinium Bromide 400 μg BID and Formoterol Fumarate 12 μg BID) and Tiotropium 18 μg QD When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

CompletedPH IIIKey trialAstraZenecan=1,5952017

A RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL STUDY TO ASSESS THE BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH WHEN ADMINISTERED TO PATIENTS WITH COPD

CompletedPH IVAstraZenecan=3002015

A Pilot, Double-blind, Placebo-controlled, 2-period Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

CompletedPH IVAstraZenecan=302015

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.