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GW642444 25
GW642444 25 is a Long-acting beta-2 agonist (LABA) Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Asthma maintenance therapy (in combination with inhaled corticosteroid), Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: LABA (444).
GW642444 is a long-acting beta-2 adrenergic receptor agonist that stimulates bronchial smooth muscle relaxation to improve airflow in respiratory disease.
GW642444 25 is a component of a medication being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and asthma. It is administered once-daily in combination with GSK573719 at a dose of 125/25 mcg.
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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 | GW642444 25 |
|---|---|
| Also known as | LABA (444) |
| Sponsor | GlaxoSmithKline |
| Drug class | Long-acting beta-2 agonist (LABA) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
As a selective beta-2 agonist, GW642444 binds to beta-2 adrenergic receptors on airway smooth muscle, triggering increased intracellular cAMP and leading to bronchodilation. The extended half-life formulation allows for once- or twice-daily dosing, providing sustained bronchospasm relief. It is typically used in combination with inhaled corticosteroids for maintenance therapy in obstructive airway diseases.
Approved indications
- Asthma maintenance therapy (in combination with inhaled corticosteroid)
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Muscle cramps
- Nervousness
Key clinical trials
- Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma (PHASE3)
- A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
- A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD (PHASE3)
- An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B (PHASE3)
- 24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (PHASE3)
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:
- GW642444 25 CI brief — competitive landscape report
- GW642444 25 updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GW642444 25
What is GW642444 25?
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Is GW642444 25 also known as anything else?
What drug class is GW642444 25 in?
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What are the side effects of GW642444 25?
What does GW642444 25 target?
Related
- Drug class: All Long-acting beta-2 agonist (LABA) drugs
- Target: All drugs targeting Beta-2 adrenergic receptor
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonology
- Indication: Drugs for Asthma maintenance therapy (in combination with inhaled corticosteroid)
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Also known as: LABA (444)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing