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Triple FF/UMEC/VI
Triple FF/UMEC/VI is a ICS/LAMA/LABA combination Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) maintenance treatment.
Triple FF/UMEC/VI is a combination inhaler containing a long-acting beta-2 agonist (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta-2 agonist (vilanterol) that work together to relax airway smooth muscle and reduce inflammation in chronic obstructive pulmonary disease.
Triple FF/UMEC/VI is a small molecule medication used to treat conditions such as chronic obstructive pulmonary disease and asthma. It is a combination of fluticasone furoate, umeclidinium bromide, and vilanterol.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Triple FF/UMEC/VI |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | ICS/LAMA/LABA combination |
| Target | Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone furoate is an inhaled corticosteroid that reduces airway inflammation. Umeclidinium is a long-acting muscarinic antagonist (LAMA) that blocks acetylcholine receptors to relax bronchial smooth muscle. Vilanterol is a long-acting beta-2 agonist (LABA) that further relaxes airway smooth muscle. The triple combination provides complementary mechanisms to improve airflow and reduce COPD exacerbations.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nasopharyngitis
Key clinical trials
- VENTURI (VENTilation Using Respiratory Imaging) (PHASE2)
- 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)
- Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI) in Participants With Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
- A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
- A Phase III Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination (FDC) of Fluticasone Furoate+Umeclidinium Bromide+Vilanterol (FF/UMEC/VI) With the FDC of FF/VI in Subjects With Inadequately Controlled Asthma (PHASE3)
- A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
- A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Triple FF/UMEC/VI CI brief — competitive landscape report
- Triple FF/UMEC/VI updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Triple FF/UMEC/VI
What is Triple FF/UMEC/VI?
How does Triple FF/UMEC/VI work?
What is Triple FF/UMEC/VI used for?
Who makes Triple FF/UMEC/VI?
What drug class is Triple FF/UMEC/VI in?
What development phase is Triple FF/UMEC/VI in?
What are the side effects of Triple FF/UMEC/VI?
What does Triple FF/UMEC/VI target?
Related
- Drug class: All ICS/LAMA/LABA combination drugs
- Target: All drugs targeting Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing