Vilanterol
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Vilanterol: From Combination COPD/Asthma Inhaler Component to Obstructive Lung Disease
One-Sentence Summary
Vilanterol is a long-acting beta2-adrenergic agonist (LABA) that, according to this Evidence Pack, has no standalone marketing authorization or documented original indication as a single ingredient — it is used exclusively as a component of fixed-dose combination inhalers. The TxGNN model predicts high relevance for Obstructive Lung Disease (i.e., COPD/asthma), a signal that is already strongly corroborated in the real world, with over 50 registered clinical trials and 20 supporting publications, including several completed Phase 3 randomized controlled trials such as IMPACT and FULFIL.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not on file for vilanterol as a single agent; known real-world use is exclusively as the LABA component in fixed-dose combination inhalers for asthma and COPD |
| Predicted New Indication | Obstructive Lung Disease |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L1 |
| EU Market Status | Not Marketed (as standalone active substance) |
| Number of Authorizations | 0 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data for vilanterol is not available (Data Gap DG002). Based on known information, vilanterol is a long-acting beta2-adrenergic agonist (LABA) that is formulated into several fixed-dose combination inhalers — with an inhaled corticosteroid (fluticasone furoate) and/or a long-acting muscarinic antagonist (umeclidinium) — and its efficacy in obstructive airway disease has been extensively demonstrated in pivotal Phase 3 programs.
The predicted new indication, “obstructive lung disease,” overlaps substantially with vilanterol’s already-established real-world use in COPD and asthma. This is therefore best understood as a confirmatory signal rather than a genuinely novel repurposing candidate: the TxGNN model is essentially re-identifying a therapeutic area in which vilanterol-containing combinations (marketed as Relvar/Breo Ellipta, Anoro Ellipta, and Trelegy Ellipta) are already guideline-recommended maintenance therapies.
Mechanistically, beta2-receptor stimulation in bronchial smooth muscle produces sustained bronchodilation, which is directly applicable across the spectrum of obstructive lung diseases (COPD, asthma, and overlap phenotypes). The large volume of completed Phase 3 evidence for vilanterol-containing combinations supports the plausibility and clinical relevance of this prediction, even though this Evidence Pack does not capture vilanterol as an independently licensed monotherapy.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT05062304 | N/A | Completed | 17,281 | Real-world replication of the IMPACT trial comparing once-daily single-inhaler triple vs. dual therapy in COPD |
| NCT02345161 | Phase 3 | Completed | 1,811 | FF/UMEC/VI once daily vs. budesonide/formoterol twice daily — improved lung function and health status in COPD |
| NCT02729051 | Phase 3 | Completed | 1,055 | ‘Closed’ triple therapy (FF/UMEC/VI) vs. ‘open’ triple therapy (FF/VI + UMEC) in COPD |
| NCT02301975 | Phase 3 | Completed | 1,526 | FF/VI once daily vs. FP/salmeterol twice daily in persistent asthma control |
| NCT02105974 | Phase 3 | Completed | 1,621 | FF/VI 100/25 mcg vs. VI alone — assessed FF’s contribution to lung function in COPD |
| NCT02257385 | Phase 3 | Completed | 967 | UMEC/VI fixed-dose combination vs. indacaterol plus tiotropium in moderate-to-very-severe COPD |
| NCT01777334 | Phase 3 | Completed | 905 | UMEC/VI once daily vs. tiotropium once daily over 24 weeks in COPD |
| NCT01316900 | Phase 3 | Completed | 846 | UMEC/VI vs. VI alone and vs. tiotropium over 24 weeks in COPD |
| NCT03474081 | Phase 4 | Completed | 800 | FF/UMEC/VI vs. tiotropium monotherapy — lung function and symptom outcomes in COPD |
| NCT01376245 | Phase 3 | Completed | 646 | FF/VI vs. placebo over 24 weeks in COPD patients of Asian ancestry |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29668352 | 2018 | RCT | N Engl J Med | IMPACT trial: single-inhaler triple therapy (FF/UMEC/VI) vs. dual therapy in COPD |
| 28375647 | 2017 | RCT | Am J Respir Crit Care Med | FULFIL trial: once-daily triple therapy demonstrates superior outcomes vs. dual ICS/LABA in COPD |
| 32918892 | 2021 | RCT (Phase 3A) | Lancet Respir Med | CAPTAIN trial: FF/UMEC/VI vs. FF/VI in inadequately controlled asthma |
| 32162970 | 2020 | RCT (secondary analysis) | Am J Respir Crit Care Med | FF/UMEC/VI significantly reduces all-cause mortality vs. UMEC/VI in COPD (IMPACT trial) |
| 31281061 | 2019 | RCT subgroup analysis | Lancet Respir Med | Blood eosinophil counts modify treatment response to triple vs. dual therapy (IMPACT trial) |
| 32299860 | 2020 | RCT subgroup analysis | Eur Respir J | Effect of exacerbation history on treatment response in the IMPACT trial |
| 39696097 | 2024 | Systematic Review/Meta-analysis | BMC Pulm Med | UMEC/VI shows clinically meaningful lung function and quality-of-life improvement vs. other bronchodilators in COPD |
| 35849317 | 2022 | Network Meta-analysis | Adv Ther | FF/UMEC/VI triple therapy compared with other combination regimens in COPD |
| 39797646 | 2024 | Cohort Study | BMJ | Comparative real-world effectiveness/safety of single-inhaler triple therapies in COPD |
| 25074268 | 2014 | Review | Drugs | Review of fluticasone furoate/vilanterol use and pharmacology in COPD |
EU Market Information
Vilanterol has no independent EU marketing authorization as a single active substance; it is only available within fixed-dose combination products (e.g., Relvar/Breo Ellipta [FF/VI], Anoro Ellipta [UMEC/VI], and Trelegy Ellipta [FF/UMEC/VI]), which fall outside the scope of this single-ingredient dataset. No standalone authorization records are available to list.
Safety Considerations
Please refer to the SmPC for safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The evidence base for vilanterol’s role in obstructive lung disease is exceptionally strong (L1), supported by dozens of completed Phase 3 RCTs including the pivotal IMPACT and FULFIL trials. However, a Blocking-severity data gap (DG001: missing regulatory label warnings/contraindications) prevents completion of the S1 safety assessment for this candidate, and no standalone EU authorization data exists for vilanterol itself.
To proceed, the following is needed:
- Obtain official product label (SmPC) warnings and contraindications for vilanterol-containing combination products to close DG001 before advancing past S1
- Obtain detailed mechanism-of-action documentation (DG002) to support formal mechanistic-linkage scoring
- Clarify regulatory scope: confirm whether repurposing evaluation should target vilanterol as a single molecule or its currently marketed combination products (FF/VI, UMEC/VI, FF/UMEC/VI)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.