DUAKLIR PRESSAIR (aclidinium bromide)
Duaklir Pressair is a fixed-dose combination of aclidinium bromide, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA). It is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is intended for twice-daily administration to maintain bronchodilation and is not indicated for the relief of acute bronchospasm or the treatment of asthma.
How DUAKLIR PRESSAIR Works
Duaklir Pressair combines two bronchodilators with different mechanisms of action. **Aclidinium bromide** is a long-acting antimuscarinic agent (anticholinergic) that inhibits M3 receptors at the smooth muscle, preventing acetylcholine-induced bronchoconstriction. **Formoterol fumarate** is a long-acting selective beta2-adrenergic agonist (LABA) that stimulates intracellular adenyl cyclase, increasing cyclic AMP levels and leading to relaxation of bronchial smooth muscle. Together, these agents provide additive bronchodilatory effects by targeting both the cholinergic and adrenergic pathways.
Details
- Status
- Prescription
- First Approved
- 2019-03-29
- Patent Cliff
- 2029
- Routes
- INHALATION
- Dosage Forms
- POWDER, METERED
DUAKLIR PRESSAIR Approval History
What DUAKLIR PRESSAIR Treats
1 indicationsDUAKLIR PRESSAIR is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
DUAKLIR PRESSAIR Competitive Set
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Direct competitors
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MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DUAKLIR PRESSAIR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03022097 AVANT results posted | D6570C00002 M-AS464-30 | Ph 3 | completed | Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients |
| NCT01966107 ASCENT COPD results posted | D6560C00002 LAS-MD-45 | Ph 4 | completed | Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients. |
| NCT02375724 M-34273-46 results posted | D6560C00001 2014-004715-37, M-34273-46 | Ph 4 | completed | BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH |
| NCT01572792 results posted | LAC-MD-36 | Ph 3 | completed | 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) |
| NCT01437397 results posted | LAC-MD-31 | Ph 3 | completed | Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| NCT01462942 results posted | M/40464/30 | Ph 3 | completed | Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination |
| NCT01045161 LAS-MD-38 results posted | LAS-MD-38 | Ph 3 | completed | Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38) |
| NCT00891462 results posted | LAS-MD-33 ACCORD COPD I | Ph 3 | completed | Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33) |
| NCT00970268 results posted | LAS-MD-36 | Ph 3 | completed | Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36) |
| NCT01462929 results posted | M/34273/39 | Ph 3 | completed | Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| NCT01471171 results posted | M/34273/40 | Ph 3 | completed | Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) |
| NCT02153489 results posted | M/34273/47 2013-003373-10 | Ph 4 | completed | A Double-blind, Placebo-controlled, 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) |
| NCT02181023 | 960CEC | Ph 4 | completed | Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DUAKLIR PRESSAIR FDA Label Details
Indications & Usage
FDA Label (PDF)DUAKLIR PRESSAIR is indicated for the treatment of Chronic Obstructive Pulmonary Disease.
DUAKLIR PRESSAIR Patents & Exclusivity
Patents (2 active)
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.