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FF/GW642444 Inhalation Powder
FF/GW642444 is a dual bronchodilator combining a long-acting beta-2 agonist (formoterol fumarate) and a long-acting muscarinic antagonist (GW642444) to relax airway smooth muscle and improve airflow.
FF/GW642444 is a dual bronchodilator combining a long-acting beta-2 agonist (formoterol fumarate) and a long-acting muscarinic antagonist (GW642444) to relax airway smooth muscle and improve airflow. Used for Chronic obstructive pulmonary disease (COPD), Asthma (in combination with inhaled corticosteroid).
At a glance
| Generic name | FF/GW642444 Inhalation Powder |
|---|---|
| Also known as | FF Inhalation Powder, Placebo, GW642444 Inhalation Powder |
| Sponsor | GlaxoSmithKline |
| Drug class | Long-acting beta-2 agonist / Long-acting muscarinic antagonist (LABA/LAMA combination) |
| Target | Beta-2 adrenergic receptor; M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formoterol component activates beta-2 adrenergic receptors to increase cAMP and cause bronchial smooth muscle relaxation. GW642444 blocks M3 muscarinic receptors to prevent acetylcholine-induced bronchoconstriction. Together, these complementary mechanisms provide sustained bronchodilation through dual pathways.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
- Asthma (in combination with inhaled corticosteroid)
Common side effects
- Tremor
- Headache
- Palpitations
- Muscle cramps
- Dry mouth
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)
- An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma (PHASE3)
- A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent 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 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder 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)
- Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components 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:
- FF/GW642444 Inhalation Powder CI brief — competitive landscape report
- FF/GW642444 Inhalation Powder updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI