Last reviewed · How we verify
Tudorza Pressair (ACLIDINIUM BROMIDE)
Tudorza Pressair (generic name: ACLIDINIUM BROMIDE) is a Anticholinergic Small molecule drug developed by Covis. It is currently FDA-approved (first approved 2012) for Maintenance treatment of COPD.
DUAKLIR PRESSAIR combines aclidinium, an anticholinergic, and formoterol, a beta 2 -adrenergic agonist, to provide bronchodilation in COPD.
Tudorza Pressair is a medication used to treat Chronic Obstructive Pulmonary Disease (COPD), specifically acting as a muscarinic acetylcholine receptor M3 antagonist. It contains the active ingredient Aclidinium Bromide, a small molecule that works by blocking the M3 receptor.
At a glance
| Generic name | ACLIDINIUM BROMIDE |
|---|---|
| Sponsor | Covis |
| Drug class | Anticholinergic |
| Target | M3 receptors, beta 2 -adrenergic receptors |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2012 |
Mechanism of action
DUAKLIR PRESSAIR contains two active ingredients: aclidinium, which blocks muscarinic receptors to prevent bronchoconstriction, and formoterol, which activates beta 2 -adrenergic receptors to relax bronchial smooth muscle. Both work together to improve breathing in COPD patients.
Approved indications
- Maintenance treatment of COPD
Common side effects
- Upper respiratory tract infection
- Headache
- Back pain
Drug interactions
- Adrenergic drugs
- Xanthine derivatives, steroids, diuretics or non-potassium sparing diuretics
- Non-potassium sparing diuretics
- Monoamine oxidase inhibitors and tricyclic antidepressants
- Beta-blockers
- Anticholinergics
Key clinical trials
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists
- Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients (PHASE3)
- A Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants (PHASE1)
- Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
- Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
- A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment
- Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial (PHASE4)
- The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours. (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tudorza Pressair CI brief — competitive landscape report
- Tudorza Pressair updates RSS · CI watch RSS
- Covis portfolio CI
Frequently asked questions about Tudorza Pressair
What is Tudorza Pressair?
How does Tudorza Pressair work?
What is Tudorza Pressair used for?
Who makes Tudorza Pressair?
What is the generic name of Tudorza Pressair?
What drug class is Tudorza Pressair in?
When was Tudorza Pressair approved?
What development phase is Tudorza Pressair in?
What are the side effects of Tudorza Pressair?
What does Tudorza Pressair target?
Related
- Drug class: All Anticholinergic drugs
- Target: All drugs targeting M3 receptors, beta 2 -adrenergic receptors
- Manufacturer: Covis — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Maintenance treatment of COPD
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing