Drugs / Fluticasone Furoate

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed asthma 2 milestones
Filed EU (EMA) Relvar Ellipta asthma 2017-07-21

“submission to the European Medicines Agency (EMA) for the extended use of once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI)” gsk.com ↗

Filed US (FDA) — asthma 2013-10-23

“today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF)” gsk.com ↗

Filed chronic obstructive pulmonary disease 3 milestones
Filed EU (EMA) — chronic obstructive pulmonary disease 2016-12-02

“filing by GSK of a regulatory submission with the European Medicines Agency for once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol” gsk.com ↗

Filed US (FDA) — chronic obstructive pulmonary disease 2016-11-21

“filing by GSK of a regulatory submission with the US Food and Drug Administration for the once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol” gsk.com ↗

Filed US (FDA) — chronic obstructive pulmonary disease 2012-09-26

“for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the US Food and Drug Administration (FDA)” gsk.com ↗

Approved Indication not stated 4 milestones
Label expansions (2) US (FDA) ARNUITY ELLIPTA — 2018-05-17 – 2023-03-01 fda.gov ↗
Label expansions (2) US (FDA) FLONASE SENSIMIST ALLERGY RELIEF — 2012-08-21 – 2016-08-02 fda.gov ↗
Approved EU (EMA) Avamys — 2008-01-11 europa.eu ↗
Approved US (FDA) FLONASE SENSIMIST ALLERGY RELIEF — 2007-04-27 fda.gov ↗

Trials 126 · started per year

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US approved 2007
EU approved 2008
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20032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 121 trials
Phase 1 NCT02837380 Sep → Nov 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02666287 Jan → Jun 2016 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT02064504 Feb → May 2014 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01837316 Oct 2013 → Aug 2014 asthma GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01962467 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01894386 Jul → Sep 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 NCT01725685 Nov 2012 → Jan 2013 asthma GlaxoSmithKline Completed No outcome recorded
Phase 1 NCT01669070 Aug → Nov 2012 asthma GlaxoSmithKline Completed No outcome recorded
Phase 215 trials · 9 met primary
Phase 2 NCT03739294 Feb 2019 → Dec 2020 — Bispebjerg Hospital Completed No outcome recorded
Phase 2 NCT02991859 Feb 2017 → Dec 2018 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT02712047 Apr 2016 → Feb 2017 asthma GlaxoSmithKline Completed Met primary
Phase 2 NCT02573870 Dec 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 Met primary
Phase 2 NCT01957202 Oct 2013 → Feb 2014 allergic rhinitis GlaxoSmithKline Completed Met primary
Phase 2 NCT01808339 Mar 2013 → Mar 2014 asthma GlaxoSmithKline Completed Met primary
Phase 2 NCT01287065 Oct 2010 → Sep 2011 asthma GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01018030 Jan → Jul 2010 sinusitis GlaxoSmithKline Completed Met primary
Phase 2 NCT00766090 Oct 2008 → Mar 2009 asthma GlaxoSmithKline Completed Met primary
Phase 360 trials · 25 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 NCT03376932 Jan 2019 → Feb 2021 asthma GlaxoSmithKline Withdrawn No outcome recorded
Phase 3 NCT03248128 Oct 2017 → Mar 2022 asthma GlaxoSmithKline Completed Mixed
Phase 3 NCT03184987 Jun 2017 → Jun 2019 asthma GlaxoSmithKline Completed No outcome recorded
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 NCT02483975 Oct 2015 → Jun 2016 asthma GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT02502734 Sep → Dec 2015 asthma GlaxoSmithKline Completed Met primary
Phase 3 NCT02446418 Jul 2015 → Jul 2017 asthma GlaxoSmithKline Completed Met primary
Phase 426 trials · 8 met primary · 3 missed
Phase 4 NCT07192016 Mar 2026 → Sep 2027 expected chronic obstructive pulmonary disease Western University, Canada Not yet recruiting No outcome recorded
Phase 4 NCT06552364 Apr 2025 → Dec 2026 expected chronic obstructive pulmonary disease University of British Columbia Not yet recruiting No outcome recorded
Phase 4 NCT06372496 Apr 2024 → Jul 2025 overdue asthma GlaxoSmithKline Active not recruiting No outcome recorded
Phase 4 NCT04923347 Jun 2023 → Mar 2024 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT05651750 Nov 2022 → May 2023 — Assaf-Harofeh Medical Center Unknown 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 NCT03949842 Jun 2019 → Nov 2022 chronic obstructive pulmonary disease GlaxoSmithKline Withdrawn No outcome recorded Stop: Enrollment
Phase 4 NCT03898466 Oct 2018 → Apr 2019 asthma University of Saskatchewan Completed No outcome recorded
Phase 4 NCT03478696 Jun 2018 → Mar 2019 chronic obstructive pulmonary disease GlaxoSmithKline Completed No outcome recorded
Phase not applicable4 trials
— NCT06066606 Oct 2023 → Jul 2026 overdue — Morten Hostrup, PhD Recruiting No outcome recorded
— NCT06077019 Oct 2023 → Jul 2026 overdue — Morten Hostrup, PhD Recruiting No outcome recorded
— NCT01562093 Jan 2012 → Jun 2016 asthma St. Olavs Hospital Terminated No outcome recorded
— NCT01318681 Jan 2011 → Mar 2012 seasonal allergic rhinitis Maastricht University Medical Center Completed No outcome recorded
Comparator or background therapy39 trials
Phase 0 NCT05381207 Comparator Oct 2022 → Oct 2024 allergic rhinitis Assiut University Unknown No outcome recorded
Phase 1 NCT02218723 Comparator Oct → Dec 2014 asthma GlaxoSmithKline Completed No outcome recorded
Phase 1/2 NCT05143502 Background Jan 2022 → Jan 2024 chronic rhinosinusitis Assiut University Unknown No outcome recorded
Phase 2 NCT04072887 Background Sep 2019 → Oct 2021 chronic obstructive pulmonary disease Novartis Pharmaceuticals Completed Missed primary
Phase 2 NCT03622112 Comparator Jan → Sep 2019 asthma AstraZeneca Completed Missed primary

News releases announcing trial results or a regulatory action · 38

DateIssuerRelease
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)
2018-05-29 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.
2018-05-21 GlaxoSmithKline Regulatory GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma gsk.com ↗
The approval is for the use of Arnuity Ellipta as maintenance treatment of asthma as prophylactic therapy in children aged 5 to 11 years, delivered as a 50mcg once-daily dose using the Ellipta inhaler.
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 ↗
The FDA also approved updates to the Warnings and Precautions section of labelling for the ICS/LABA class.
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 ↗

All press releases naming this drug 39 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 167 sources stand behind the page.

FieldValueCited text
Known as fluticasone furoate “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
139

“An Open Label, Part-randomised, Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate (FF)...” NCT01669070 ↗

“The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and...” NCT01018030 ↗

“The study aim was to investigate the pharmacokinetics of single high doses and repeated therapeutic doses of fluticasone furoate (FF) and batefenterol (BAT; a bifunctional...” PMID 30070770 ↗ Aug 2018

“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 ↗

“Participants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+...” NCT06552364 ↗

“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

“Subjects in group A (study) will be treated with Fluticasone Furoate nasal: (50 micrograms/spray) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast...” NCT05381207 ↗

“A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic...” NCT03474081 ↗

Show 129 more sources

Known as ALLERMIST “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗
Known as Avamys “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗
2

“AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis” NCT01270958 ↗

“Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD” NCT04621513 ↗

Known as AVAMYS (TM) “AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis” NCT01270958 ↗
Known as FFNS “The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and...” NCT01018030 ↗
5

“Fluticasone furoate nasal spray (FFNS) is a novel, enhanced-affinity intranasal corticosteroid administered for the management of allergic rhinitis (AR).” PMID 21888757 ↗ Aug 2011

“The effect of fluticasone furoate nasal spray (FFNS) on growth in prepubescent children has not been evaluated.” PMID 25017530 ↗ May 2014

“Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg” NCT02424539 ↗

“fluticasone furoate nasal spray \[FFNS\]” NCT00609674 ↗

NCT00519636 ↗

Known as Fluticasone furoate nasal spray “an intranasal corticosteroid (fluticasone furoate nasal spray” NCT00609674 ↗
2

“fluticasone furoate nasal spray 110ug, once daily” NCT01231464 ↗

“fluticasone furoate nasal spray” NCT00539006 ↗

Known as GW685698 “A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)” NCT01551758 ↗
5

“fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI)” NCT01395888 ↗

“Fluticasone furoate (FF, GW685698) is a novel once daily inhaled corticosteroid (ICS)” 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 ↗

Known as GW685698X “GW685698X (fluticasone furoate) 100mcg Morning” NCT01499446 ↗
23

NCT00522678 ↗

NCT00398645 ↗

NCT00116883 ↗

NCT00108914 ↗

NCT00116818 ↗

NCT00103454 ↗

NCT00197262 ↗

NCT00109486 ↗

NCT00117325 ↗

NCT00419237 ↗

Show 13 more sources

Known as VERAMYST “FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™).” NCT01000597 ↗
2

“Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray” NCT01279057 ↗

“Fluticasone Furoate Nasal Spray (Veramyst)” NCT01076439 ↗

Action Activate “GW685698X is a novel glucocorticoid receptor agonist” NCT00522678 ↗
Modality Other / unclassified “intranasal steroid inhibits the nasal ocular reflex” PMID 23406601 ↗ Jan 2013
Route Intranasal “Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg” NCT00103454 ↗