Vilanterol

also known as GW642444 · GW642444M · GW642444H · vilanterol trifenatate · vilanterol trifenatae

Developed for: chronic obstructive pulmonary disease · asthma · heart failure · respiratory system disorder
Investigated by: GlaxoSmithKline · Parexel · Morten Hostrup, PhD · AstraZeneca · Baylor Research Institute · Bispebjerg Hospital
+12 more
· Dr. Grace Parraga · Luis Puente Maestu · Medical University of Bialystok · National Institute of Respiratory Diseases, Mexico · Novartis Pharmaceuticals · Queen's University · Rigshospitalet, Denmark · Samsung Medical Center · Sandoz · University of Saskatchewan · University of Virginia · Western University, Canada

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed asthma 1 milestone
Filed	EU (EMA)	Relvar Ellipta	asthma	2017-07-21	“today announced a submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI)” gsk.com ↗
Approved Indication not stated 1 milestone
Approved	EU (EMA)	Relvar Ellipta	—	2013-11-13	europa.eu ↗

Trials 114 · started per year

today

EU approved 2013

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Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 123 trials
Phase 1	NCT02837380	Sep → Nov 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01837316	Oct 2013 → Aug 2014	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01894386	Jul → Sep 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01899638	May → Jul 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01691547	Dec 2012 → Mar 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01711463	Dec 2012 → Jun 2013	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01571999	Mar → Jun 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01577680	Mar → Jun 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01521377	Dec 2011 → Jun 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01213849	Oct → Nov 2010	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01165125	Jul → Aug 2010	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01209026	Jun 2010 → Jan 2011	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01286831	May → Jul 2010	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01299558	May → Jul 2010	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00976144	Jul → Sep 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00783003	Nov 2008 → Feb 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00711126	Oct → Dec 2008	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00964249	Sep → Dec 2008	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00671216	May → Jul 2008	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00702910	Apr → Oct 2008	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00625196	Feb → May 2008	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00463697	Apr → Aug 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00469040	Feb → Apr 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded

Phase 215 trials · 5 met primary
Phase 2	NCT03739294	Feb 2019 → Dec 2020	—	Bispebjerg Hospital	Completed	No outcome recorded
Phase 2	NCT03645434	Oct 2018 → Aug 2019	chronic obstructive pulmonary disease	AstraZeneca	Completed	Met primary
Phase 2	NCT03002389	Nov 2017 → Dec 2023 overdue	chronic obstructive pulmonary disease	University of Virginia	Active not recruiting	No outcome recorded
Phase 2	NCT02712047	Apr 2016 → Feb 2017	asthma	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT02570165	Nov 2015 → Jul 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT02164539	Jul 2014 → Jul 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT01453023	Oct 2011 → Jun 2012	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01287065	Oct 2010 → Sep 2011	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01039675	Jan → Apr 2010	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00980200	Sep 2009 → Jan 2010	asthma	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00749411	Nov 2008 → Feb 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00731822	Aug 2008 → Feb 2009	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00519376	Aug → Nov 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00347139	May 2006 → Jan 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00354874	Jan → Jun 2005	asthma	GlaxoSmithKline	Completed	No outcome recorded

Phase 355 trials · 30 met primary · 10 missed
Phase 3	NCT07223294	Apr 2026	respiratory system disorder	Sandoz	Withdrawn	No outcome recorded Stop: Business
Phase 3	NCT04651777	Aug 2022 → Aug 2023 overdue	asthma	Dr. Grace Parraga	Active not recruiting	No outcome recorded
Phase 3	NCT04536675	Apr 2021 → Apr 2026 overdue	chronic obstructive pulmonary disease, non-small cell lung carcinoma	Samsung Medical Center	Active not recruiting	No outcome recorded
Phase 3	NCT03376932	Jan 2019 → Feb 2021	asthma	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 3	NCT03248128	Oct 2017 → Mar 2022	asthma	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT02924688	Oct 2016 → Feb 2019	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02729051	Jun 2016 → May 2017	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT02487498	Jul 2015 → Sep 2016	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Missed primary
Phase 3	NCT02446418	Jul 2015 → Jul 2017	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02301975	Mar 2015 → Nov 2016	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02345161	Jan 2015 → Apr 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT02257385	Oct 2014 → May 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01899742	Sep 2014 → Jul 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02152605	Sep 2014 → Mar 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02164513	Jun 2014 → Jul 2017	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02105974	Apr 2014 → Jul 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02094937	Mar 2014 → Aug 2015	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01879410	Jun 2013 → Jan 2014	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01822899	Apr → Oct 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01817764	Mar → Oct 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01777334	Jan → Sep 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01706198	Nov 2012 → Dec 2016	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01691885	Nov 2012 → Jul 2014	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01706328	Oct 2012 → Jun 2013	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01686633	Sep 2012 → Oct 2013	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01551758	Mar 2012 → Nov 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01498653	Jan 2012 → Feb 2013	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01491802	Jan 2012 → Sep 2014	chronic obstructive pulmonary disease	Queen's University	Completed	Missed primary
Phase 3	NCT01376388	Aug 2011 → Dec 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01395888	Jun 2011 → Aug 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01323634	Mar → Dec 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01323621	Mar 2011 → Jan 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01323660	Mar 2011 → Jul 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01336608	Mar 2011 → Nov 2014	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01313637	Mar 2011 → Mar 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01313650	Mar 2011 → Apr 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01316900	Mar 2011 → Apr 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01328444	Mar 2011 → Jun 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Mixed
Phase 3	NCT01316913	Mar 2011 → Apr 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01342913	Feb → Oct 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01313676	Jan 2011 → Jul 2015	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01316887	Jan 2011 → Jul 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01181895	Sep 2010 → Aug 2011	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01165138	Aug 2010 → Oct 2011	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01192191	Aug 2010 → Jan 2012	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01244984	Jul 2010 → Jan 2012	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01134042	Jun 2010 → Oct 2011	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01147848	Jun 2010 → Jul 2011	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT01086384	Feb 2010 → Sep 2011	asthma	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01072149	Jan → Jul 2010	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01054885	Oct 2009 → Feb 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01018186	Oct 2009 → May 2011	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01053988	Oct 2009 → Feb 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01017952	Sep 2009 → Oct 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01009463	Sep 2009 → Oct 2011	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Mixed

Phase 418 trials · 4 met primary · 2 missed
Phase 4	NCT07192016	Mar 2026 → Sep 2027 expected	chronic obstructive pulmonary disease	Western University, Canada	Not yet recruiting	No outcome recorded
Phase 4	NCT06372496	Apr 2024 → Jul 2025 overdue	asthma	GlaxoSmithKline	Active not recruiting	No outcome recorded
Phase 4	NCT06571942	Nov 2023 → Jan 2025 overdue	chronic obstructive pulmonary disease	National Institute of Respiratory Diseases, Mexico	Recruiting	No outcome recorded
Phase 4	NCT04923347	Jun 2023 → Mar 2024	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT05535972	Oct 2022 → Sep 2023	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT05292053	Jul 2022 → Sep 2024	chronic obstructive pulmonary disease	Baylor Research Institute	Completed	No outcome recorded
Phase 4	NCT04522596	May 2021 → May 2026	chronic obstructive pulmonary disease, heart failure	Luis Puente Maestu	Completed	No outcome recorded
Phase 4	NCT03949842	Jun 2019 → Nov 2022	chronic obstructive pulmonary disease	GlaxoSmithKline	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT03478696	Jun 2018 → Mar 2019	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT03467425	Apr 2018 → Oct 2019	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT03474081	Mar 2018 → Jul 2019	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT03363191	Mar 2018 → May 2019	asthma	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 4	NCT03315000	Oct 2017 → May 2018	asthma	University of Saskatchewan	Completed	No outcome recorded
Phase 4	NCT03034915	Jun 2017 → Jun 2018	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT02799784	Jul 2016 → Apr 2017	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 4	NCT02730351	May 2016 → Feb 2017	asthma	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT02275052	Jan 2015 → Jun 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Missed primary
Phase 4	NCT01957150	Jan 2014 → Mar 2018	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded

Phase not applicable3 trials
—	NCT07541378	Mar 2024 → Feb 2025	chronic obstructive pulmonary disease	Medical University of Bialystok	Suspended	No outcome recorded Stop: Enrollment
—	NCT06077019	Oct 2023 → Jul 2026 overdue	—	Morten Hostrup, PhD	Recruiting	No outcome recorded
—	NCT06066606	Oct 2023 → Jul 2026 overdue	—	Morten Hostrup, PhD	Recruiting	No outcome recorded
Comparator or background therapy26 trials
Phase 1	NCT02666287 Background	Jan → Jun 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT04072887 Background	Sep 2019 → Oct 2021	chronic obstructive pulmonary disease	Novartis Pharmaceuticals	Completed	Missed primary
Phase 2	NCT01573624 Comparator	Apr 2012 → Feb 2013	asthma	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT01573767 Comparator	Apr 2012 → Apr 2014	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01453296 Comparator	Aug 2010 → Apr 2011	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01128569 Comparator	Jan → Oct 2010	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00606684 Comparator	Feb → Oct 2008	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00372112 Comparator	Nov 2006 → May 2007	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT05757102 Background	Apr 2023 → Jan 2027 expected	asthma	GlaxoSmithKline	Recruiting	No outcome recorded
Phase 3	NCT03162055 Comparator	May 2017 → May 2018	chronic obstructive pulmonary disease	AstraZeneca	Completed	Mixed
Phase 3	NCT02753712 Comparator	Jun 2016 → Aug 2017	asthma	Mundipharma Research Limited	Completed	No outcome recorded
Phase 3	NCT02731846 Background	Jun → Nov 2016	chronic obstructive pulmonary disease	GlaxoSmithKline	Withdrawn	No outcome recorded
Phase 3	NCT02467452 Comparator	May 2015 → Jan 2017	chronic obstructive pulmonary disease	Chiesi Farmaceutici S.p.A.	Completed	No outcome recorded
Phase 3	NCT01957163 Background	Oct 2013 → Apr 2014	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT02119286 Background	Oct 2013 → Apr 2014	chronic obstructive pulmonary disease	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01498679 Comparator	Jan 2012 → Jul 2013	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 3	NCT01435902 Comparator	Jan → Aug 2012	asthma	GlaxoSmithKline	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT06552364 Comparator	Apr 2025 → Dec 2026 expected	chronic obstructive pulmonary disease	University of British Columbia	Not yet recruiting	No outcome recorded
Phase 4	NCT07133880 Comparator	Dec 2023 → Dec 2025 overdue	chronic obstructive pulmonary disease	University of Tennessee Graduate School of Medicine	Recruiting	No outcome recorded
Phase 4	NCT04671355 Comparator	Oct → Dec 2021	chronic obstructive pulmonary disease	Chiesi Farmaceutici S.p.A.	Withdrawn	No outcome recorded
Phase 4	NCT03611699 Comparator	Jan 2019 → Apr 2020	chronic obstructive pulmonary disease	Gary L. Pierce	Completed	No outcome recorded
Phase 4	NCT03380429 Background	Jan 2018 → Jan 2019	asthma	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT05342558 Comparator	Sep 2017 → Nov 2020	chronic obstructive pulmonary disease	National Institute of Respiratory Diseases, Mexico	Completed	No outcome recorded
Phase 4	NCT03152149 Comparator	Jun 2017 → Nov 2019	chronic obstructive pulmonary disease	University of Dundee	Completed	No outcome recorded
—	NCT07329946 Background	Sep 2026 → Feb 2027 expected	chronic obstructive pulmonary disease	Pierachille Santus, MD, PhD	Not yet recruiting	No outcome recorded
—	NCT07058259 Background	Nov 2024 → Jun 2025 overdue	chronic obstructive pulmonary disease	Istanbul Medeniyet University	Active not recruiting	No outcome recorded

News releases announcing trial results or a regulatory action · 45

Date	Issuer	Release
2026-01-23	GlaxoSmithKline	Regulatory Trelegy Ellipta approved in China for use in adults with uncontrolled asthma gsk.com ↗ The approval means that FF/UMEC/VI is the first and only single inhaler triple therapy (SITT) approved for the maintenance treatment of both respiratory conditions in the country.
2020-09-09	GlaxoSmithKline	Regulatory FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US gsk.com ↗ The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg.
2020-02-27	GlaxoSmithKline	Regulatory GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma gsk.com ↗ today announced the acceptance of a regulatory submission seeking an additional indication for the use of once-daily, single-inhaler triple therapy, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI)
2018-08-23	AstraZeneca	Results AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease astrazeneca.com ↗ In the trial, Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1) but did not demonstrate superiority on peak FEV1 or non-inferiority on trough FEV1.
2018-05-29	GlaxoSmithKline	Regulatory GSK submits regulatory application in Japan for once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD gsk.com ↗ We are delighted to have filed a new drug application for the first single inhaler triple therapy for the treatment of COPD in Japan where the prevalence of COPD is of public concern.
2018-04-18	GlaxoSmithKline	Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗ A 42.1% reduction in the risk of on-treatment all-cause mortality was observed for Trelegy compared to Anoro (1.20% vs. 1.88%; p=0.011).
2018-03-08	GlaxoSmithKline	Regulatory GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗ We welcome this approval, which signifies an important milestone for Relvar Ellipta.
2018-02-15	Theravance Biopharma	Regulatory Theravance Biopharma Highlights Submission of Landmark IMPACT Data to EMA to Support Expanded Label for Trelegy Ellipta theravance.com ↗ Theravance Biopharma, Inc. (NASDAQ: TBPH) (" Theravance Biopharma ") today highlighted the submission of the landmark IMPACT study data to the European Medicines Agency (EMA) as part of a type II variation to support an expanded label for Trelegy Ellipta in Europe for the maintenance treatment of moderate to severe chronic obstructive pulmonary disease (COPD).
2018-01-26	GlaxoSmithKline	Regulatory GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗ We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients
2017-12-21	GlaxoSmithKline	Regulatory FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗ These labelling updates were approved on December 20th 2017, after a review of safety data from 4 randomized controlled safety trials submitted by three companies, including GSK.
2017-11-01	GlaxoSmithKline	Results GSK study demonstrates superiority of Anoro Ellipta to Stiolto Respimat in improving lung function in chronic obstructive pulmonary disease gsk.com ↗ This endpoint was met and, furthermore, UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight (UMEC/VI 180mL vs. TIO/OLO 128mL; 95% CI: 28, 77; p<0.001).
2017-09-20	GlaxoSmithKline	Results GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗
2017-09-15	GlaxoSmithKline	Regulatory Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD gsk.com ↗
2017-09-11	GlaxoSmithKline	Results Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress gsk.com ↗ GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced positive results from the Salford Lung Study (SLS) in asthma have been simultaneously published in The Lancet journal and presented at the European Respiratory Society (ERS) International Congress in Milan.
2017-07-21	GlaxoSmithKline	Regulatory GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination gsk.com ↗
2017-05-05	GlaxoSmithKline	Results Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care gsk.com ↗ This open-label, randomised study showed that significantly more asthma patients initiated on treatment with Relvar Ellipta 100/25mcg or 200/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved an improvement in their asthma control compared with patients who continued to take their usual care medicines.
2017-02-23	GlaxoSmithKline	Results Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗ In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function.
2016-12-02	GlaxoSmithKline	Regulatory Relvar® Ellipta® 100/25 mcg gains approval in Japan for use in patients with COPD gsk.com ↗ today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Relvar® Ellipta® (fluticasone furoate / vilanterol 100/25 mcg) for the relief of various symptoms with chronic obstructive pulmonary disease (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).
2016-09-06	GlaxoSmithKline	Results GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗ In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41; p<0.001).
2016-09-04	GlaxoSmithKline	Results GSK announce positive results from the COPD Salford Lung Study published in the NEJM and presented at European Respiratory Congress gsk.com ↗ A similar reduction in exacerbations with FF/VI was seen in those patients on an ICS/long-acting beta2-agonist (LABA) at baseline (8.0%; 95% CI 0.11 to 15.4, p=0.047).
2016-06-20	GlaxoSmithKline	Results FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗
2016-05-24	GlaxoSmithKline	Results Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’ gsk.com ↗ The study showed that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versus usual care, in patients with COPD, in an everyday clinical practice setting.
2016-05-18	GlaxoSmithKline	Results GSK presents efficacy data for Anoro® Ellipta® in COPD patients who remained symptomatic on tiotropium gsk.com ↗ These efficacy data demonstrate the improvement in lung function that can be achieved in patients with moderate COPD when changing treatment from monotherapy with tiotropium 18mcg to dual bronchodilation with Anoro Ellipta.
2015-09-24	GlaxoSmithKline	Results Regulatory update: GSK and Theravance announce intention to file Relvar® Ellipta® for COPD in Japan gsk.com ↗ The study which included 1620 patients with COPD, of whom 370 were from Japan, showed that patients who received FF/VI 100/25mcg achieved a statistically significant improvement in lung function (as measured by change from baseline in trough FEV1) compared with VI 25mcg at 12 weeks (p=0.001).
2015-04-30	GlaxoSmithKline	Regulatory FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US gsk.com ↗ Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
2015-03-19	GlaxoSmithKline	Regulatory GSK and Theravance announce outcome of US FDA Advisory Committee on BREO® ELLIPTA® in asthma gsk.com ↗ The FDA Advisory Committee voted that the efficacy and safety data for FF/VI 100/25 mcg and 200/25 mcg once daily in asthma support approval in adults 18 years of age and older (16 for, 4 against).
2014-10-17	GlaxoSmithKline	Results Data published on Anoro® Ellipta® demonstrate improved lung function compared to tiotropium gsk.com ↗
2014-09-08	GlaxoSmithKline	Results GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗
2014-07-04	GlaxoSmithKline	Regulatory Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD gsk.com ↗
2014-06-30	GlaxoSmithKline	Regulatory GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma gsk.com ↗
2014-03-14	GlaxoSmithKline	Results GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗ We are pleased to announce the results from these positive studies, which provide physicians with further data regarding UMEC/VI as a treatment option for appropriate patients with COPD.
2013-12-18	GlaxoSmithKline	Regulatory ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US gsk.com ↗
2013-12-06	GlaxoSmithKline	Results GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma gsk.com ↗ GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced positive results from a phase III efficacy and safety study of fluticasone furoate “FF”/vilanterol “VI” designed to support a potential filing for an asthma indication for adults in the US.
2013-11-18	GlaxoSmithKline	Regulatory RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD gsk.com ↗
2013-09-20	GlaxoSmithKline	Regulatory RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma gsk.com ↗ today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved RELVAR™ ELLIPTA™ for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required).
2013-07-12	GlaxoSmithKline	Regulatory Regulatory update: fluticasone furoate/vilanterol submission in Japan gsk.com ↗ As a result, a decision has been taken to withdraw COPD from the current JNDA at this time.
2013-05-10	GlaxoSmithKline	Regulatory BREO™ ELLIPTA™ gains US approval for the treatment of COPD gsk.com ↗ GlaxoSmithKline plc (LSE/NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO™ ELLIPTA™ as an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
2013-04-22	GlaxoSmithKline	Regulatory GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan gsk.com ↗
2013-04-17	GlaxoSmithKline	Regulatory FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD gsk.com ↗ This positive recommendation is a crucial first step towards making BREO ELLIPTA available for appropriate COPD patients across the US.
2013-02-19	GlaxoSmithKline	Regulatory GSK and Theravance announce FDA acceptance of New Drug Application (NDA) submission in the US for ANORO ELLIPTATM for COPD gsk.com ↗ GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review.
2013-01-09	GlaxoSmithKline	Regulatory GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe gsk.com ↗ A Marketing Authorisation Application (MAA) for UMEC/VI (55/22mcg and 113/22mcg doses), with the proposed proprietary name ANORO™, has been submitted to the European Medicines Agency (EMA) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.
2012-12-18	GlaxoSmithKline	Regulatory GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US gsk.com ↗ GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).
2012-01-09	GlaxoSmithKline	Results GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma gsk.com ↗ A 4-week detailed lung function profile study in 54 patients demonstrated that all doses of FF/VI (50/25mcg, 100/25mcg, and 200/25mcg) statistically significantly increased weighted mean FEV1 versus placebo.
2011-06-02	GlaxoSmithKline	Results GSK and Theravance announce results of two pivotal Phase III studies for Relovair in COPD gsk.com ↗
2010-09-21	GlaxoSmithKline	Results GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗ The most common adverse events (FFVI; placebo) were nasopharyngitis (18%;15%), headache (15%; 5%), dizziness (5%; 5%) and candidiasis (8%;0%).

All press releases naming this drug 49 releases

Date	Issuer	Release
2026-01-23	GlaxoSmithKline	Trelegy Ellipta approved in China for use in adults with uncontrolled asthma gsk.com ↗
2020-09-09	GlaxoSmithKline	FDA approves Trelegy Ellipta as the first once-daily single inhaler triple therapy for the treatment of both asthma and COPD in the US gsk.com ↗
2020-02-27	GlaxoSmithKline	GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma gsk.com ↗
2018-08-23	AstraZeneca	AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease astrazeneca.com ↗
2018-05-29	GlaxoSmithKline	GSK submits regulatory application in Japan for once-daily single inhaler triple therapy FF/UMEC/VI for patients with COPD gsk.com ↗
2018-04-18	GlaxoSmithKline	Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
2018-03-08	GlaxoSmithKline	GSK announces positive EU approval for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗
2018-02-15	Theravance Biopharma	Theravance Biopharma Highlights Submission of Landmark IMPACT Data to EMA to Support Expanded Label for Trelegy Ellipta theravance.com ↗
2018-01-26	GlaxoSmithKline	GSK announces CHMP positive opinion for labelling update to Relvar Ellipta in patients with asthma gsk.com ↗
2017-12-21	GlaxoSmithKline	FDA approves US label update on ICS/LABA combinations in asthma, based on review of safety data gsk.com ↗
2017-11-01	GlaxoSmithKline	GSK study demonstrates superiority of Anoro Ellipta to Stiolto Respimat in improving lung function in chronic obstructive pulmonary disease gsk.com ↗
2017-09-20	GlaxoSmithKline	GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations gsk.com ↗
2017-09-15	GlaxoSmithKline	Trelegy Ellipta once-daily single inhaler triple therapy receives positive opinion from the CHMP in Europe for appropriate patients with COPD gsk.com ↗
2017-09-11	GlaxoSmithKline	Positive results from pioneering Salford Lung Study in asthma published in The Lancet, and presented at European Respiratory Congress gsk.com ↗
2017-07-21	GlaxoSmithKline	GSK submits EU filing for extended use of Relvar Ellipta in patients with controlled asthma on an ICS/LABA combination gsk.com ↗
2017-05-05	GlaxoSmithKline	Relvar Ellipta significantly improved asthma control in Salford Lung Study patients compared with their usual care gsk.com ↗
2017-02-23	GlaxoSmithKline	Positive results for Relvar® Ellipta® lung function study in patients with well-controlled asthma gsk.com ↗
2016-12-02	GlaxoSmithKline	Relvar® Ellipta® 100/25 mcg gains approval in Japan for use in patients with COPD gsk.com ↗
2016-09-06	GlaxoSmithKline	GSK presents positive results from phase III FULFIL study of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in COPD at ERS International Congress gsk.com ↗
2016-09-04	GlaxoSmithKline	GSK announce positive results from the COPD Salford Lung Study published in the NEJM and presented at European Respiratory Congress gsk.com ↗
2016-06-20	GlaxoSmithKline	FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients gsk.com ↗
2016-05-24	GlaxoSmithKline	Salford Lung Study results show COPD patients treated with Relvar® Ellipta® achieve superior reduction in exacerbations compared with ‘usual care’ gsk.com ↗
2016-05-18	GlaxoSmithKline	GSK presents efficacy data for Anoro® Ellipta® in COPD patients who remained symptomatic on tiotropium gsk.com ↗
2015-09-24	GlaxoSmithKline	Regulatory update: GSK and Theravance announce intention to file Relvar® Ellipta® for COPD in Japan gsk.com ↗
2015-04-30	GlaxoSmithKline	FDA approves BREO® ELLIPTA® for the treatment of adults with asthma in the US gsk.com ↗
2015-03-19	GlaxoSmithKline	GSK and Theravance announce outcome of US FDA Advisory Committee on BREO® ELLIPTA® in asthma gsk.com ↗
2014-10-17	GlaxoSmithKline	Data published on Anoro® Ellipta® demonstrate improved lung function compared to tiotropium gsk.com ↗
2014-09-08	GlaxoSmithKline	GSK data presented at ERS demonstrate potential of blood eosinophil levels to help inform COPD treatment decisions gsk.com ↗
2014-07-04	GlaxoSmithKline	Anoro® Ellipta® (umeclidinium/vilanterol) gains approval in Japan for the treatment of COPD gsk.com ↗
2014-06-30	GlaxoSmithKline	GSK and Theravance announce submission to US regulatory authorities for fluticasone furoate/vilanterol in asthma gsk.com ↗
2014-05-08	GlaxoSmithKline	Anoro® (umeclidinium/vilanterol) gains marketing authorisation in Europe for the treatment of COPD gsk.com ↗
2014-04-22	GlaxoSmithKline	GSK and Theravance announce phase III study of fluticasone furoate/vilanterol in COPD commenced to support potential future filing in Japan gsk.com ↗
2014-03-14	GlaxoSmithKline	GSK and Theravance announce positive results from studies comparing ANORO™ ELLIPTA™ with SERETIDE® DISKUS® and ADVAIR® DISKUS® in patients with COPD gsk.com ↗
2014-02-20	GlaxoSmithKline	Anoro® (umeclidinium / vilanterol) receives positive opinion from the CHMP in Europe for the treatment of COPD gsk.com ↗
2013-12-18	GlaxoSmithKline	ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US gsk.com ↗
2013-12-06	GlaxoSmithKline	GSK and Theravance announce positive results from pivotal phase III study for fluticasone furoate/vilanterol in asthma gsk.com ↗
2013-11-18	GlaxoSmithKline	RELVAR® ELLIPTA® receives European marketing authorisation for the treatment of asthma and COPD gsk.com ↗
2013-09-20	GlaxoSmithKline	RELVAR™ ELLIPTA™ gains approval in Japan for the treatment of asthma gsk.com ↗
2013-09-10	GlaxoSmithKline	FDA Advisory Committee recommends approval in US of umeclidinium/vilanterol for the treatment of COPD gsk.com ↗
2013-07-12	GlaxoSmithKline	Regulatory update: fluticasone furoate/vilanterol submission in Japan gsk.com ↗
2013-05-10	GlaxoSmithKline	BREO™ ELLIPTA™ gains US approval for the treatment of COPD gsk.com ↗
2013-04-22	GlaxoSmithKline	GSK and Theravance announce regulatory submission for ANORO™ ELLIPTA™ (UMEC/VI) in Japan gsk.com ↗
2013-04-17	GlaxoSmithKline	FDA Advisory Committee recommends approval of BREO(TM) ELLIPTA(TM) for the treatment of COPD gsk.com ↗
2013-02-19	GlaxoSmithKline	GSK and Theravance announce FDA acceptance of New Drug Application (NDA) submission in the US for ANORO ELLIPTATM for COPD gsk.com ↗
2013-01-09	GlaxoSmithKline	GSK and Theravance announce regulatory submission for ANORO™ (UMEC/VI) in Europe gsk.com ↗
2012-12-18	GlaxoSmithKline	GSK and Theravance announce regulatory submission for UMEC/VI (LAMA/LABA) in the US gsk.com ↗
2012-01-09	GlaxoSmithKline	GSK and Theravance announce initial outcomes from pivotal Phase III studies for once-daily Relovair™* in COPD and asthma gsk.com ↗
2011-06-02	GlaxoSmithKline	GSK and Theravance announce results of two pivotal Phase III studies for Relovair in COPD gsk.com ↗
2010-09-21	GlaxoSmithKline	GSK and Theravance announce combination ICS/LABA Phase II results in the Relovair™ development programme gsk.com ↗

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 141 sources stand behind the page.

Field	Value	Cited text
Known as	vilanterol	“We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a...” PMID 31720293 ↗ Nov 2019 105 “Participants will inhale a ultra Long-Acting Beta-Agonist (LABA; vilanterol (25mcg)) + Long-acting Muscarinic Antagonist (LAMA; umeclidinium (62.5mcg)) combination medication...” NCT06552364 ↗ “Dual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a...” NCT07058259 ↗ “Umeclidinium (UMEC; long-acting muscarinic antagonist [LAMA])/vilanterol (VI; long-acting beta2-agonist [LABA]) and fluticasone propionate/salmeterol (FP/SAL) (inhaled...” PMID 26006754 ↗ May 2015 “A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation...” NCT01706328 ↗ “A 12-week, Prospective, Open Label, Single Cohort Study to Evaluate the Real-world Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler...” NCT05535972 ↗ “Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol...” NCT03376932 ↗ “pharmacokinetics of fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI) in patients with chronic obstructive pulmonary disease (COPD) when administered as a...” PMID 31321713 ↗ Jan 2020 “OBJECTIVE: To evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in...” PMID 24253831 ↗ Nov 2013 “A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic...” NCT03474081 ↗ “All subjects received fluticasone furoate/vilanterol ELLIPTA dry-powder inhalers for maintenance and salbutamol/albuterol metered-dose inhalers for rescue, with a sensor...” PMID 33334936 ↗ Jun 2021 Show 95 more sources
Known as	GW642444	“A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)” NCT01551758 ↗ 42 “fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI)” NCT01395888 ↗ “GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI)” NCT01039675 ↗ “selected doses and dose intervals of GW642444 Administered Via a Novel Dry Powder Inhaler (NDPI)” NCT00980200 ↗ “vilanterol (VI, GW642444) is an inhaled once daily long-acting beta2 agonist (LABA)” NCT01453023 ↗ “Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder” NCT02446418 ↗ “Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder” NCT01706198 ↗ “GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)” NCT01498679 ↗ “GW642444 is a potent and selective long-acting beta-2 agonist.” NCT00976144 ↗ “Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg” NCT01323634 ↗ “Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg” NCT01323621 ↗ Show 32 more sources
Known as	GW642444H	“Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate.” NCT00519376 ↗ 1 “Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate.” NCT00463697 ↗
Known as	GW642444M	“Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate.” NCT00519376 ↗ 3 “Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate.” NCT00463697 ↗ “repeat dose GSK573719/GW642444M (Vilanterol) combination” NCT01521377 ↗ “FF/Vilanterol (VI; GW642444M)” NCT01128569 ↗
Known as	vilanterol trifenatae	“second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate” NCT03034915 ↗
Known as	vilanterol trifenatate	“Fluticasone furoate/umeclidinium bromide/vilanterol trifenatate” NCT06372496 ↗ 1 “GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)” NCT01498679 ↗
Action	Activate	“long acting beta agonist GW642444” NCT00749411 ↗
Modality	Other / unclassified	“The inhaled corticosteroid fluticasone furoate (FF) and the long-acting β₂ agonist vilanterol (VI) are in development as a combined once-daily therapy for asthma and chronic...” PMID 24136330 ↗ Oct 2013
Route	Inhaled	“Three Inhaled Doses (25, 100 and 400 mcg Once Daily) of GW642444” NCT00347139 ↗