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Incruse Ellipta (UMECLIDINIUM)
Incruse Ellipta (generic name: UMECLIDINIUM) is a Anticholinergic Small molecule drug developed by Glaxo Grp England. It is currently FDA-approved (first approved 2013) for Asthma, Chronic bronchitis, Chronic obstructive lung disease.
Umeclidinium works by blocking the M4 muscarinic acetylcholine receptor to relax airway smooth muscle and improve breathing.
Incruse Ellipta is a small molecule medication used to treat Chronic Obstructive Pulmonary Disease (COPD) and Asthma. It contains the active ingredient umeclidinium, which is administered via inhalation in a dose of 62.5 mcg.
At a glance
| Generic name | UMECLIDINIUM |
|---|---|
| Sponsor | Glaxo Grp England |
| Drug class | Anticholinergic |
| Target | Muscarinic acetylcholine receptor M4 |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 3100 |
Mechanism of action
Umeclidinium is long-acting muscarinic antagonist, which is often referred to as an anticholinergic. It has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptors at the smooth muscle leading to bronchodilation. The competitive and reversible nature of antagonism was shown with human and animal origin receptors and isolated organ preparations. In preclinical in vitro as well as in vivo studies, prevention of methacholine- and acetylcholine-induced bronchoconstrictive effects was dose-dependent and lasted longer than 24 hours. The clinical relevance of these findings is unknown. The bronchodilation following inhalation of umeclidinium is predominantly site-specific effect.
Approved indications
- Asthma
- Chronic bronchitis
- Chronic obstructive lung disease
- Pulmonary emphysema
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Cough
- Arthralgia
- Myalgia
- Abdominal pain upper
- Toothache
- Contusion
- Tachycardia
- Atrial fibrillation
- Urinary tract infection
- Pneumonia
Key clinical trials
- Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma (PHASE4)
- VENTURI (VENTilation Using Respiratory Imaging) (PHASE2)
- Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study (PHASE4)
- Immuno-inflammatory Response of Erdosteine in COPD (NA)
- To Evaluate Real-World Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol (FF/UMEC/VI) in a Single Inhaler (Trelegy Ellipta) in Participants With Symptomatic COPD (PHASE4)
- Outcomes of Once-Daily ICS/LABA/LAMA + PRN Respiratory Therapy Treatments in Hospitalized Patients With COPD Exacerbations (PHASE4)
- A Study to Compare the Efficacy, Safety and Tolerability of FF/UMEC/VI With FF/VI in 12-17-year-olds With Asthma (PHASE3)
- 129-Xe MRI Study of Single Triple Therapy Inhaler Effects in COPD Patients With Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation (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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Incruse Ellipta CI brief — competitive landscape report
- Incruse Ellipta updates RSS · CI watch RSS
- Glaxo Grp England portfolio CI
Frequently asked questions about Incruse Ellipta
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Related
- Drug class: All Anticholinergic drugs
- Target: All drugs targeting Muscarinic acetylcholine receptor M4
- Manufacturer: Glaxo Grp England — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma
- Indication: Drugs for Chronic bronchitis
- Indication: Drugs for Chronic obstructive lung disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing