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Breo Ellipta (VILANTEROL)
Breo Ellipta works by stimulating the beta-2 adrenergic receptor to relax airway muscles and improve breathing.
Breo Ellipta (VILANTEROL) is a small molecule beta2-adrenergic agonist developed by Glaxo Group Ltd, targeting the beta-2 adrenergic receptor to treat asthma, chronic bronchitis, chronic obstructive lung disease, and pulmonary emphysema. It was FDA-approved in 2013 and remains under the ownership of Glaxo Group Ltd. Breo Ellipta works by stimulating the beta-2 adrenergic receptor, leading to bronchodilation and improved lung function. The commercial status of Breo Ellipta is patented, and its half-life is approximately 2.4 hours. Key safety considerations include potential cardiovascular effects and exacerbation of asthma symptoms.
At a glance
| Generic name | VILANTEROL |
|---|---|
| Sponsor | Glaxo Grp Ltd |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 3100 |
Mechanism of action
Fluticasone Furoate/Vilanterol ELLIPTASince Fluticasone Furoate/Vilanterol ELLIPTA contains both fluticasone furoate and vilanterol, the mechanisms of action described below for the individual components apply to Fluticasone Furoate/Vilanterol ELLIPTA. These drugs represent different classes of medications (a synthetic corticosteroid and LABA) that have different effects on clinical and physiological indices.Fluticasone FuroateFluticasone furoate is synthetic trifluorinated corticosteroid with anti-inflammatory activity. Fluticasone furoate has been shown in vitro to exhibit binding affinity for the human glucocorticoid receptor that is approximately 29.9 times that of dexamethasone and 1.7 times that of fluticasone propionate. The clinical relevance of these findings is unknown. The precise mechanism through which fluticasone furoate affects COPD and asthma symptoms is not known. Inflammation is an important component in the pathogenesis of COPD and asthma. Co
Approved indications
- Asthma
- Chronic bronchitis
- Chronic obstructive lung disease
- Pulmonary emphysema
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Oropharyngeal candidiasis
- Back pain
- Pneumonia
- Bronchitis
- Sinusitis
- Cough
- Oropharyngeal pain
- Arthralgia
- Hypertension
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)
- Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma (PHASE3)
- 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)
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:
- Breo Ellipta CI brief — competitive landscape report
- Breo Ellipta updates RSS · CI watch RSS
- Glaxo Grp Ltd portfolio CI