Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GW685698
GW685698/GW642444 · 4 trials · 3 indications
Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.
Co-Primary Endpoint. Weighted mean was derived by calculating the average area under the curve (AUC), and then dividing by the relevant time interval. Baseline is the most recent result taken on or before pre-dose Day 1. Heart rate was recorded at 60 minutes (min) prior to dosing and at 15 min, 45 min, 90 min, 120 min, and 240 min post-dose on Day 28. Change from Baseline was calculated as the Day 28 value minus the Baseline value. Analysis was performed using a restricted maximum likelihood (REML)-based repeated measures mixed model approach (MMRM) with covariates of Baseline heart rate, sex, age, smoking status, treatment, and day and day by treatment and day by Baseline interactions. par.=participants.
Co-Primary Endpoint. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect. See the SAE/AE module of this results summary for a list of specific SAEs/AEs occurring in the study.
| Arm | Type | Description |
|---|---|---|
| FF/VI 200/25mcg once daily | EXPERIMENTAL | ICS/LABA |
| Fluticasone propionate 500mcg twice daily | ACTIVE_COMPARATOR | ICS |
| fluticasone furoate/vilanterol trifenatate | ACTIVE_COMPARATOR | Inhaled corticosteroid (ICS)/Long-acting beta2-agonist (LABA) combination |
| Placebo | PLACEBO_COMPARATOR | placebo comparator |
| Name | Type | Description |
|---|---|---|
| GW685698/GW642444 | DRUG | ICS/LABA |
| CCI18781 | DRUG | ICS |
| GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate) | DRUG | ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI) |
| Placebo | DRUG | Placebo administered once daily in the evening via a NDPI |
| GW685698 | DRUG | - |
Inclusion Criteria: 1. Informed Consent: All subjects must be able and willing to give written informed consent to take part in the study 2. Type of Subject: Outpatients, of Asian ancestry, 12 years of age or older at Visit 1 (or ≥18 years of age or older if local regulations or the regulatory stat...
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 |
GW685698/GW642444 is an investigational small molecule combination developed by GSK plc for respiratory conditions. It has been studied in asthma, chronic obstructive pulmonary disease, and allergic rhinitis. The combination pairs fluticasone furoate with vilanterol trifenatate. Development has reached Phase 3, and the completed trials enrolled a total of 624 participants across the studied indications.
GW685698/GW642444 has been studied for asthma, chronic obstructive pulmonary disease, and allergic rhinitis. The Phase 3 asthma trials enrolled adolescents and adults of Asian ancestry in China, the Philippines, and South Korea. A Phase 2 trial evaluated a single dosage strength in COPD, and a Phase 3 study assessed perennial allergic rhinitis. It remains investigational.
GSK plc, which trades under the ticker GSK, is the developer of GW685698/GW642444. The company sponsored the clinical trials evaluating the fluticasone furoate and vilanterol trifenatate combination across asthma, chronic obstructive pulmonary disease, and allergic rhinitis. GSK is the sole developer named for this asset.
GW685698/GW642444 has reached Phase 3 development. Two Phase 3 asthma trials, NCT01498679 and NCT01498653, have completed, along with a Phase 3 perennial allergic rhinitis study and a Phase 2 COPD trial. The drug is investigational and is not described as approved. No trials are currently listed as active.
Completed trials include NCT01498679 and NCT01498653, Phase 3 asthma studies in adolescents and adults of Asian ancestry that enrolled 311 and 313 participants. NCT00731822 was a Phase 2 COPD study with 60 participants in Norway and Sweden. NCT00358475 was a Phase 3 perennial allergic rhinitis study with 65 participants. All were randomized, double-blind, and placebo-controlled.