Umeclidinium
Other / unclassified targets CHRM3 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 5 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 | Japan (PMDA) | — | chronic obstructive pulmonary disease | 2014-05-23 | “today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for umeclidinium (UMEC)” gsk.com ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | 2013-04-30 | “A New Drug Application (NDA) for UMEC monotherapy (62.5mcg) has been submitted to the US Food and Drug Administration (FDA)” gsk.com ↗ |
| Filed | EU (EMA) | — | chronic obstructive pulmonary disease | 2013-04-26 | “A Marketing Authorisation Application (MAA) for UMEC monotherapy (55 mcg delivered dose) has been submitted to the European Medicines Agency (EMA)” gsk.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | INCRUSE ELLIPTA | — | 2016-02-24 – 2019-06-06 | fda.gov ↗ |
| Approved | EU (EMA) | Incruse Ellipta (previously Incruse) | — | 2014-04-28 | europa.eu ↗ |
| Approved | US (FDA) | ANORO ELLIPTA | — | 2013-12-18 | fda.gov ↗ |
Trials 84 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT02837380 | Sep → Nov 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01934153 | Sep 2013 → Feb 2014 | — | 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 | NCT01725685 | Nov 2012 → Jan 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 | NCT01521390 | Oct → Dec 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01362257 | Apr → Jun 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01128634 | Mar → Apr 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01013974 | Oct → Dec 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00976144 | Jul → Sep 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00803673 | May → Oct 2008 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00475436 | May → Sep 2007 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 214 trials · 8 met primary · 1 missed | ||||||
| Phase 2 | NCT07807007 | Nov 2025 → Aug 2026 | asthma | Shanghai Xin Huanghe Pharmaceutical Co., Ltd. | 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 | NCT03012061 | Jan 2017 → May 2018 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT02673619 | Mar → Dec 2016 | isolated hyperchlorhidrosis | Stiefel, a GSK Company | Completed | Missed primary |
| Phase 2 | NCT02563899 | Nov 2015 → Feb 2016 | isolated hyperchlorhidrosis | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | NCT01641692 | May 2012 → Feb 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01573624 | Apr 2012 → Feb 2013 | asthma | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01372410 | Jul → Oct 2011 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01039675 | Jan → Apr 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01030965 | Dec 2009 → Jul 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT00732472 | Oct 2008 → Aug 2009 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 335 trials · 21 met primary · 2 missed | ||||||
| Phase 3 | NCT05757102 | Apr 2023 → Jan 2027 expected | asthma | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT04651777 | Aug 2022 → Aug 2023 overdue | asthma | Dr. Grace Parraga | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04937387 | Jul 2021 → Aug 2024 | asthma | GlaxoSmithKline | Completed | 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 | 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 | NCT02731846 | Jun → Nov 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 3 | NCT02184611 | May 2016 → Nov 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02487498 | Jul 2015 → Sep 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed 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 | NCT02207829 | Sep 2014 → May 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 | NCT01957163 | Oct 2013 → Apr 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT02119286 | Oct 2013 → Apr 2014 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| 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 | NCT01772147 | Jan → Aug 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01702363 | Aug 2012 → Dec 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01636713 | Jul 2012 → Oct 2013 | chronic obstructive pulmonary disease | 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 | NCT01387230 | Jul 2011 → Feb 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01323660 | Mar 2011 → Jul 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 | NCT01313637 | Mar 2011 → Mar 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 | NCT01313650 | Mar 2011 → Apr 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01316913 | Mar 2011 → Apr 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT01316887 | Jan 2011 → Jul 2012 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 418 trials · 6 met primary · 1 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 | NCT03662711 | Nov 2018 → Oct 2022 | chronic obstructive pulmonary disease | Università degli Studi di Ferrara | Terminated | No outcome recorded |
| Phase 4 | NCT03478683 | Jun 2018 → Mar 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | 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 | Met primary |
| Phase 4 | NCT03474081 | Mar 2018 → Jul 2019 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| 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 | NCT02275052 | Jan 2015 → Jun 2016 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT02257372 | Sep 2014 → Mar 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase 4 | NCT02236611 | Sep 2014 → Jun 2015 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07541378 | Mar 2024 → Feb 2025 | chronic obstructive pulmonary disease | Medical University of Bialystok | Suspended | No outcome recorded Stop: Enrollment |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT01110018 Comparator | Apr → Jun 2010 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT03378648 Comparator | Dec 2017 → Apr 2019 | asthma, chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT04072887 Background | Sep 2019 → Oct 2021 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT00515502 Comparator | Jun → Nov 2007 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03162055 Comparator | May 2017 → May 2018 | chronic obstructive pulmonary disease | AstraZeneca | Completed | Mixed |
| Phase 3 | NCT02729051 Comparator | Jun 2016 → May 2017 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01772134 Comparator | Jan → Jul 2013 | chronic obstructive pulmonary disease | GlaxoSmithKline | Completed | No outcome recorded |
| 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 | NCT03611699 Comparator | Jan 2019 → Apr 2020 | chronic obstructive pulmonary disease | Gary L. Pierce | 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 |
| — | 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 · 24
| 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. |
| 2018-04-25 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Approval of Expanded Indication in the US for Once-Daily Trelegy Ellipta for Treatment of COPD Patients theravance.com ↗
This expanded approval in the US allows Trelegy Ellipta to be used as a treatment for a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms. |
| 2018-04-19 | Theravance Biopharma | Results Theravance Biopharma Highlights Landmark IMPACT Study Published in NEJM Showing Significant Benefits of Trelegy Ellipta for COPD Patients theravance.com ↗ |
| 2018-04-18 | GlaxoSmithKline | Results Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD gsk.com ↗
A statistically significant 34% reduction in COPD hospitalisations (severe exacerbations) for Trelegy compared to Anoro (0.13 vs. 0.19 per year; p<0.001) and a reduction of 13% compared to Relvar/Breo which was not statistically significant (0.13 vs. 0.15; p=0.064). |
| 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). |
| 2017-11-28 | Theravance Biopharma | Regulatory Theravance Biopharma Highlights Submission of Landmark IMPACT Data to FDA to Support Expanded Label for Trelegy Ellipta theravance.com ↗ |
| 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). |
| 2017-09-15 | 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 ↗ |
| 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. |
| 2015-10-20 | GlaxoSmithKline | Results GSK announces positive new data comparing Incruse® Ellipta® to tiotropium and glycopyrronium in patients with COPD gsk.com ↗
Results from the randomised, blinded* study 201316 showed that umeclidinium 62.5mcg once daily achieved a statistically significant improvement in lung function measured by trough forced expiratory volume in one second (FEV1) at 12 weeks (P<0.001), compared to tiotropium 18mcg administered once daily. |
| 2015-03-26 | GlaxoSmithKline | Regulatory GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Encruse® Ellipta® (umeclidinium) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (COPD). |
| 2014-05-23 | GlaxoSmithKline | Regulatory GSK announces regulatory submission for umeclidinium monotherapy for COPD in Japan gsk.com ↗
GlaxoSmithKline plc (LSE: GSK) today announced the submission of a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), administered using the Ellipta™ dry powder inhaler. |
| 2014-05-19 | GlaxoSmithKline | Results GSK presents positive data at ATS 2014 from study evaluating efficacy and safety of Incruse™ Ellipta® added to Advair® Diskus® in patients with COPD gsk.com ↗ |
| 2014-04-30 | GlaxoSmithKline | Regulatory GSK receives approval for Incruse™ Ellipta® (umeclidinium) in the US for the treatment of COPD gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Incruse™ Ellipta® (umeclidinium) as an anticholinergic indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
| 2014-04-28 | GlaxoSmithKline | Regulatory GSK receives EU marketing authorisation for Incruse (umeclidinium) for the treatment of COPD gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the European Commission has granted marketing authorisation for Incruse® (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2014-04-17 | GlaxoSmithKline | Regulatory GSK announces approval in Canada for Incruse Ellipta (umeclidinium) as a treatment for COPD gsk.com ↗
This is the first market authorisation granted for this product anywhere in the world. |
| 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 ↗
UMEC/VI achieved a statistically significant improvement in lung function |
| 2014-02-20 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion for Incruse® (umeclidinium) for the treatment of COPD gsk.com ↗ |
| 2013-12-18 | GlaxoSmithKline | Regulatory ANORO™ ELLIPTA™ approved as first once-daily dual bronchodilator for the treatment of COPD in the US gsk.com ↗ |
| 2013-04-30 | GlaxoSmithKline | Regulatory GSK announces regulatory submission for umeclidinium monotherapy in US gsk.com ↗
A New Drug Application (NDA) for UMEC monotherapy (62.5mcg) has been submitted to the US Food and Drug Administration (FDA), for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. |
All press releases naming this drug 38 releases
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 104 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Umeclidinium | “We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a...” PMID 31720293 ↗ Nov 201959“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 “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 “A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic...” NCT03474081 ↗ “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 ↗ “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 “A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)” NCT02152605 ↗ |
| Known as | Anoro ellipta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Bromure d'umeclidinium | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Bromuro de umeclidinio | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | FF/UMEC/VI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04937387 ↗ |
| Known as | FF/UMEC/VI (100/31.25/25) mcg | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02924688 ↗ |
| Known as | Fluticasone Furoate/Umeclidinium/Vilanterol | “Efficacy and Safety of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Chinese Participants With Inadequately Controlled Asthma” NCT04937387 ↗1“Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy” NCT03478683 ↗ |
| Known as | GSK-573719A | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | GSK573719 | “GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI)” NCT01039675 ↗26“Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colourless solution, free from visible particulates, for topical application.” NCT02673619 ↗ “Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colorless solution, free from visible particulates, for topical application.” NCT02563899 ↗ “A Healthy Volunteer Study With Inhaled GSK573719 and Placebo” NCT00803673 ↗ “umeclidinium (GSK573719) / vilanterol (GW642444)” NCT01491802 ↗ “GSK573719 Inhalation Powder (125mcg and 62.5mcg)” NCT01328444 ↗ |
| Known as | Incruse ellipta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Incruse ellipta (previously incruse) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Rolufta ellipta (previously rolufta) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | UMEC | “We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a...” PMID 31720293 ↗ Nov 201929“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 “A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic...” NCT03474081 ↗ “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 ↗ “Umeclidinium bromide (UMEC) 62.5 μg is a long-acting muscarinic antagonist (LAMA) that is administered once daily via inhalation for chronic obstructive pulmonary disease...” PMID 26782971 ↗ Feb 2016 “Inhaled umeclidinium (UMEC) and the combination of inhaled UMEC with vilanterol (UMEC/VI) are approved maintenance treatments for chronic obstructive pulmonary disease in the US and EU.” PMID 25816315 ↗ Mar 2015 “A 24 Week Efficacy Study of Inhaled Umeclidinium (UMEC) in Patients of Chronic Obstructive Pulmonary Disease (COPD) Using a Novel Dry Powder Inhaler (NDPI)” NCT02184611 ↗ “A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)” NCT02152605 ↗ “Umeclidinium bromide (UMEC) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease (COPD).” PMID 24393134 ↗ Jan 2014 “The long-acting muscarinic antagonists umeclidinium (UMEC) and tiotropium (TIO) are approved once-daily maintenance therapies for COPD.” PMID 27103795 ↗ Apr 2016 “evaluated the effectiveness and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus usual care ICS/LABA in adults” PMID 42474701 ↗ Jul 2026 |
| Known as | Umeclidinium brom | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | umeclidinium bromide | “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 ↗21“Umeclidinium bromide/vilanterol (umeclidinium bromide 62.5 mcg; vilanterol 25mcg inhalation powder; trade name Anoro Ellipta) is a combination long-acting bronchodilator that...” NCT03611699 ↗ “Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide:...” NCT02164539 ↗ “Umeclidinium bromide (UMEC) 62.5 μg is a long-acting muscarinic antagonist (LAMA) that is administered once daily via inhalation for chronic obstructive pulmonary disease...” PMID 26782971 ↗ Feb 2016 “Umeclidinium bromide, long-acting muscarinic antagonist (LAMA). Administered as 55 μg, 1 inhalation once daily via Ellipta inhaler for 28 days in combination with vilanterol.” NCT07541378 ↗ “Umeclidinium bromide (UMEC) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease (COPD).” PMID 24393134 ↗ Jan 2014 “Contains budesonide 195 μg, formoterol fumarate 5.5 μg, and umeclidinium bromide (equivalent to umeclidinium 27.5 μg) per inhalation.” NCT07807007 ↗ “Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Patients With Asthma” NCT03184987 ↗ “Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg.” NCT02119286 ↗ “Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg.” NCT01957163 ↗ “the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate” NCT03034915 ↗ |
| Known as | Umeclidinium bromide component of trelegy ellipta | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Umeclidinium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Umeclidinium ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL1187833 ↗ |
| Known as | Umeclinidium bromide | “GSK573719 (Umeclinidium bromide) 15.6 mcg once-daily” NCT01641692 ↗ |
| Known as | umedlidinium | “The investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol.” NCT04651777 ↗ |
| Action | Inhibit | “GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist” NCT00515502 ↗1“Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1187833 ↗ |
| Modality | Other / unclassified | “long-acting muscarinic antagonist” NCT01491802 ↗ |
| Route | Inhaled | “when administered via inhalation” NCT00475436 ↗ |
| Target | CHRM3 | “Muscarinic acetylcholine receptor M3 antagonist” CHEMBL1187833 ↗ |