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GSK573719/GW642444 Inhalation Powder
GSK573719/GW642444 Inhalation Powder is a LAMA/LABA combination (long-acting muscarinic antagonist/long-acting beta-2 agonist) Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
GSK573719/GW642444 is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) that relaxes airway smooth muscle and reduces mucus secretion to improve airflow in chronic obstructive pulmonary disease.
GSK573719/GW642444 is a combination of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA) that relaxes airway smooth muscle and reduces mucus secretion to improve airflow in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
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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 | GSK573719/GW642444 Inhalation Powder |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | LAMA/LABA combination (long-acting muscarinic antagonist/long-acting beta-2 agonist) |
| Target | M3 muscarinic receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
GSK573719 (umeclidinium) blocks muscarinic M3 receptors on airway smooth muscle, preventing acetylcholine-induced bronchoconstriction. GW642444 (vilanterol) activates beta-2 adrenergic receptors, causing bronchodilation. Together, these complementary mechanisms provide dual bronchodilation for sustained airway opening and improved lung function in COPD patients.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nasopharyngitis
Key clinical trials
- A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD (PHASE3)
- A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD (PHASE3)
- A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD (PHASE3)
- A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects (PHASE1)
- QTc Study GSK573719+GW642444 (PHASE1)
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:
- GSK573719/GW642444 Inhalation Powder CI brief — competitive landscape report
- GSK573719/GW642444 Inhalation Powder updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK573719/GW642444 Inhalation Powder
What is GSK573719/GW642444 Inhalation Powder?
How does GSK573719/GW642444 Inhalation Powder work?
What is GSK573719/GW642444 Inhalation Powder used for?
Who makes GSK573719/GW642444 Inhalation Powder?
What drug class is GSK573719/GW642444 Inhalation Powder in?
What development phase is GSK573719/GW642444 Inhalation Powder in?
What are the side effects of GSK573719/GW642444 Inhalation Powder?
What does GSK573719/GW642444 Inhalation Powder target?
Related
- Drug class: All LAMA/LABA combination (long-acting muscarinic antagonist/long-acting beta-2 agonist) drugs
- Target: All drugs targeting M3 muscarinic receptor; beta-2 adrenergic receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing