Drugs / Vilanterol

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Relvar Ellipta 2013-11-13 europa.eu

Trials 114 · started per year

today
EU approved 2013
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20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
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 215 trials
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 No outcome recorded
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 No outcome recorded
Phase 2 NCT02570165 Nov 2015 → Jul 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT02164539 Jul 2014 → Jul 2015 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
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 No outcome recorded
Phase 355 trials
Phase 3 NCT07223294 Apr 2026 respiratory system disorder Sandoz Withdrawn No outcome recorded
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 No outcome recorded
Phase 3 NCT02924688 Oct 2016 → Feb 2019 asthma GlaxoSmithKline Completed No outcome recorded
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 No outcome recorded
Phase 3 NCT02446418 Jul 2015 → Jul 2017 asthma GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT02301975 Mar 2015 → Nov 2016 asthma GlaxoSmithKline Completed No outcome recorded
Phase 418 trials
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 → Dec 2024 chronic obstructive pulmonary disease, heart failure Luis Puente Maestu Unknown No outcome recorded
Phase 4 NCT03949842 Jun 2019 → Nov 2022 chronic obstructive pulmonary disease GlaxoSmithKline Withdrawn No outcome recorded
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 No outcome recorded
Phase not applicable3 trials
NCT07541378 Mar 2024 → Feb 2025 chronic obstructive pulmonary disease Medical University of Bialystok Suspended No outcome recorded
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
Also used as a comparator or background therapy in 26 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02666287 Background Jan → Jun 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 27 trials
Phase 2 NCT04072887 Background Sep 2019 → Oct 2021 chronic obstructive pulmonary disease Novartis Pharmaceuticals Completed No outcome recorded
Phase 2 NCT01573624 Comparator Apr 2012 → Feb 2013 asthma GlaxoSmithKline Completed No outcome recorded
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 39 trials
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 No outcome recorded
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 47 trials
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 not applicable2 trials
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

Evidence & citations 9 cited values

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

FieldValueCited 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

“A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary...” NCT02275052

“Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI.” NCT01957163

“Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI.” NCT02119286

“A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)” NCT01551758

“Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.” PMID 25816315 Mar 2015

“Comparative Efficacy of Once-Daily Umeclidinium/Vilanterol and Tiotropium/Olodaterol Therapy in Symptomatic Chronic Obstructive Pulmonary Disease: A Randomized Study.” PMID 29094315 Nov 2017

Vilanterol, long-acting beta2-agonist (LABA). Administered as 22 μg, 1 inhalation once daily via Ellipta inhaler for 28 days in combination with umeclidinium.” NCT07541378

“Fixed Combination Of Fluticasone Furoate Plus Vilanterol Administered Via Dry Powder Inhaler (DPI) (Relvar®) Plus Tiotropium Bromide (Spiriva®)” NCT02467452

“A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)” NCT02152605

“Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma” NCT03248128

“The investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol.” NCT04651777

“long-acting muscarinic antagonist/β2-agonist combination umeclidinium/vilanterol (UMEC/VI) compared with UMEC and VI monotherapies” PMID 23830094 Jul 2013

“Fluticasone Furoate (FF)/ Umeclidinium (UMEC)/ Vilanterol (VI) on lung function compared with FF/VI after 24 weeks of treatment.” NCT05757102

“second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate” NCT03034915

“inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days” NCT03002389

“TRELEGY ELLIPTA (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder)” NCT05292053

“two 1-year randomised, controlled trials of fluticasone furoate (FF)/vilanterol (VI) versus VI alone” PMID 27251682 Jun 2016

“fixed-dose combination bronchodilator (umeclidinium/vilanterol (UMEC/VI); 62.5 µg/25 µg)” PMID 34503985 Apr 2022

“Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study.” PMID 24385182 May 2014

“Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy” NCT03478696

“Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg])” NCT02837380

“combination fluticasone furoate (FF)/vilanterol (VI) in Asian asthma patients.” PMID 25524507 Oct 2014

Vilanterol is available as vilanterol inhalation powder (25 mcg per blister)” NCT02164539

“second strip contains Vilanterol (unit dose strengths 25 mcg per blister)” NCT02257385

“Combination of fluticasone furoate, vilanterol and umeclidinium bromide” NCT04072887

“Fluticasone Furoate (FF)/ Vilanterol (VI) 100/25 mcg Combination” NCT01837316

“once daily in case of umeclidinium bromide/vilanterol 55/22 mcg” NCT07329946

“Fluticasone Furoate (FF)/Umeclidinium(UMEC)/Vilanterol (VI)” NCT04923347

Vilanterol is a long-acting beta2 agonist (LABA).” NCT01691547

“the long-acting β2-agonist (LABA) vilanterol (VI)” PMID 33598874 Feb 2021

“umeclidinium (GSK573719) / vilanterol (GW642444)” NCT01491802

“or vilanterol 25 mcg (a long-acting β-agonist)” PMID 25452139 Oct 2014

“umeclidinium (UMEC) plus vilanterol (VI)” PMID 24835833 May 2014

Vilanterol (VI)” NCT01894386

NCT03315000

NCT03152149

NCT05342558

NCT01336608

NCT01777334

NCT06571942

NCT02753712

NCT04522596

NCT01577680

NCT01342913

NCT02164513

NCT01498679

NCT01957150

NCT02570165

NCT02105974

NCT01323634

NCT01323621

NCT01686633

NCT02446418

NCT02712047

NCT01691885

NCT04536675

NCT01822899

NCT01706198

NCT06077019

NCT01313676

NCT00625196

NCT02666287

NCT07133880

NCT02345161

NCT01711463

NCT02301975

NCT06066606

NCT03162055

NCT01181895

NCT02094937

NCT01571999

NCT02731846

NCT03739294

NCT06372496

NCT01287065

NCT01453023

NCT01899742

NCT01165138

NCT01128569

NCT01213849

NCT01817764

NCT01521377

NCT01134042

NCT01395888

NCT01573767

NCT04671355

NCT07223294

NCT03611699

NCT02730351

NCT03363191

NCT03949842

NCT01435902

NCT02487498

NCT01147848

NCT07192016

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

“umeclidinium (GSK573719) / vilanterol (GW642444)” NCT01491802

NCT01299558

NCT01376388

NCT00519376

NCT01192191

NCT01328444

NCT00783003

NCT01244984

NCT00372112

NCT01323660

NCT01018186

NCT01053988

NCT01054885

NCT00671216

NCT01316913

NCT01009463

NCT01316887

NCT00711126

NCT00463697

NCT00964249

NCT00749411

NCT01165125

NCT01072149

NCT00606684

NCT01453296

NCT00469040

NCT00354874

NCT00731822

NCT01209026

NCT00702910

NCT01286831

NCT00347139

Known as GW642444H “Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate.” NCT00463697
1

“Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate.” NCT00519376

Known as GW642444M “Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate.” NCT00463697
3

“Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate.” NCT00519376

“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 “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