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Also known as vilanterol (VI)
Vilanterol · 1 trial · 1 indication
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline FEV1, region, sex, age, and treatment.
| Arm | Type | Description |
|---|---|---|
| Vilanterol | EXPERIMENTAL | Vilanterol inhalation powder once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
| Salmeterol | ACTIVE_COMPARATOR | Placebo inhalation powder via NDPI once daily + Salmeterol inhalation powder twice daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo inhalation powder via NDPI once daily + Placebo inhalation powder via Diskus twice daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Vilanterol | DRUG | Vilanterol inhalation powder inhaled orally once daily for 12 weeks |
| Salmeterol Inhalation Powder | DRUG | Salmeterol inhalation powder inhaled orally twice daily for 12 weeks |
| Placebo Inhalation Powder NDPI | DRUG | Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler |
| Placebo Inhalation Powder Diskus | DRUG | Placebo inhalation powder inhaled orally twice daily for 12 weeks |
Inclusion Criteria: * Outpatient at least 12 years of age * Both genders; females of childbearing potential must be willing to use birth control method * Clinical diagnosis of asthma for ≥12 weeks * Best pre-bronchodilator FEV1 of 40%-90% predicted * Reversibility of FEV1 of at least 12% and 200mls...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Vilanterol is an investigational inhaled therapy being studied for the treatment of persistent asthma in adults and adolescents. It is delivered as an inhalation powder and is in Phase 3 clinical development. It is not yet approved for asthma, and its safety and efficacy are still being evaluated in clinical trials.
Vilanterol is a small molecule agonist of ADRB2, the beta-2 adrenergic receptor. By activating this receptor, it acts as a bronchodilator, helping to relax airway smooth muscle and improve airflow. This mechanism is intended to relieve the bronchoconstriction associated with persistent asthma.
Vilanterol is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating vilanterol inhalation powder in asthma.
Vilanterol is in Phase 3 clinical development for persistent asthma. The Phase 3 trial has been completed, but the drug remains investigational and has not been approved for marketing. No active trials are currently listed for this asset.
Vilanterol has been evaluated in one completed Phase 3 trial, NCT01181895, titled "Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma." The trial enrolled 348 participants across the United States, Germany, Peru, Poland, and Ukraine.