Drugs / Glycopyrronium
Glycopyrronium
also known as
glycopyrronium bromide · NVA237 · GPB · Qbrexza · GLY · glycopyrrolate · glycopyrronium tosylate · PT001 · +5 more
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic obstructive pulmonary disease 3 milestones | |||||
| Filed | Japan (PMDA) | — | chronic obstructive pulmonary disease | 2011-11-25 | “Novartis files NDA for NVA237 as a treatment for chronic obstructive pulmonary disease (COPD) in Japan” nxera.life ↗ |
| Filed | EU (EMA) | Seebri Breezhaler | chronic obstructive pulmonary disease | 2011-09-27 | “NVA237 has been filed for marketing authorisation by Novartis with the European Medicines Agency (EMA) under the brand-name Seebri® Breezhaler®” nxera.life ↗ |
| Filed | US (FDA) | — | chronic obstructive pulmonary disease | — | “NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, as used in the GEM trials, has been submitted for US registration.” novartis.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | QBREXZA | — | 2018-06-28 | fda.gov ↗ |
| Approved | EU (EMA) | Enurev Breezhaler | — | 2012-09-28 | europa.eu ↗ |
Trials 97 · started per year
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EU approved 2012
US approved 2018
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News releases announcing trial results or a regulatory action · 73
| Date | Issuer | Release |
|---|---|---|
| 2026-09-23 | AstraZeneca | Regulatory Trixeo approved in the EU for the maintenance treatment of asthma astrazeneca.com ↗
Trixeo is the first and only triple-combination therapy approved in the EU for patients 12 years and older, independent of exacerbation history |
| 2026-09-03 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi advances its Carbon Minimal Inhaler journey as European submissions for its Single Inhaler Triple Therapy (SITT) and ICS/LABA combination next-generation propellant pMDIs are validated chiesi.com ↗
Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe. |
| 2026-08-04 | Proveca Pharma Limited | Regulatory Proveca Receives Positive CHMP Opinion for Sialanar® (Glycopyrronium) Orodispersible Tablets (ODT), Expanding Choice in the Management of Severe Sialorrhoea proveca.com ↗
Proveca has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Sialanar® orodispersible tablets (ODT) for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders. |
| 2026-07-31 | Chiesi Farmaceutici S.p.A. | Regulatory Chiesi receives European Marketing Authorisation for its Single Inhaler Triple Therapy delivered via NEXThaler® for the maintenance treatment of Asthma chiesi.com ↗
The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May 2026. |
| 2026-02-13 | AstraZeneca | Results Positive and clinically meaningful results from the Phase III KALOS and LOGOS trials for Breztri in patients with uncontrolled asthma published in The Lancet Respiratory Medicine astrazeneca.com ↗
In the pooled analysis of KALOS and LOGOS, Breztri also demonstrated clinically meaningful reductions in the annualised rate of severe asthma exacerbations versus ICS/LABA medicines in patients with or without a recent asthma exacerbation. |
| 2025-05-12 | AstraZeneca | Regulatory Trixeo Aerosphere approved in the UK as first inhaled respiratory medicine using next-generation propellant with near-zero Global Warming Potential astrazeneca.com ↗ |
| 2025-05-02 | AstraZeneca | Results Breztri met primary endpoints in KALOS and LOGOS Phase III trials in asthma astrazeneca.com ↗
Positive high-level results from the Phase III KALOS and LOGOS trials in patients with uncontrolled asthma showed that AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) met all primary endpoints |
| 2023-02-01 | Dr. August Wolff GmbH & Co. KG Arzneimittel | Results Langzeit-Studiendaten mit einer 1% igen GPB-Creme gegen starkes Schwitzen unter den Achseln im JEADV veröffentlicht drwolffgroup.com ↗
Alle Endpunkte, wie die Reduktion der Schweißmenge nach 12 Wochen oder die Verbesserung der Lebensqualität wurden erreicht, trotzt einer Reduktion der Anwendungshäufigkeit. |
| 2022-02-11 | Journey Medical Corporation | Regulatory QBREXZA® (Rapifort® Wipes 2.5%) Receives Manufacturing and Marketing Approval in Japan Triggering $2.5 Million Milestone Payment to Journey Medical Corporation journeymedicalcorp.com ↗
Japan's Ministry of Health, Labor and Welfare (“MHLW”) approved Rapifort® Wipes 2.5% (glycopyrronium tosylate hydrate) for the treatment of primary axillary hyperhidrosis. |
| 2021-09-03 | Novartis Pharmaceuticals | Results Novartis presents new findings at ERS reinforcing the efficacy of Enerzair® Breezhaler®, highlighting its digital companion, as well as showcasing commitment to low carbon footprint asthma solutions novartis.com ↗ |
| 2021-03-22 | Dr. August Wolff GmbH & Co. KG Arzneimittel | Regulatory Dr. August Wolff hat EU-Zulassung eines Medikaments gegen krankhaftes Schwitzen in der Achselhöhle beantragt drwolffgroup.com ↗
Die Einreichung der Zulassungsdossiers erfolgte am 26. Februar 2021 im dezentralen Verfahren (DCP) für Deutschland, Schweden und weitere 9 EU-Länder. |
| 2020-12-14 | AstraZeneca | Regulatory Trixeo Aerosphere approved in the EU for maintenance treatment of COPD astrazeneca.com ↗ |
| 2020-10-19 | AstraZeneca | Regulatory Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD astrazeneca.com ↗ |
| 2020-09-07 | Novartis Pharmaceuticals | Results Novartis post hoc analysis shows high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings novartis.com ↗
High-dose, once-daily Enerzair ® Breezhaler ® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks |
| 2020-07-24 | AstraZeneca | Regulatory Breztri Aerosphere approved in the US for the maintenance treatment of COPD astrazeneca.com ↗
AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) has been approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). |
| 2020-07-07 | Novartis Pharmaceuticals | Regulatory Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU novartis.com ↗
European Commission approves once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS |
| 2020-06-29 | Novartis Pharmaceuticals | Regulatory Novartis receives simultaneous approval for five new products from Japanese Ministry of Health, Labour and Welfare, offering Japanese patients a broad range of novel treatment options novartis.com ↗ |
| 2020-06-24 | AstraZeneca | Results Breztri Aerosphere significantly reduced rate of moderate or severe COPD exacerbations in Phase III ETHOS trial astrazeneca.com ↗
Compared with Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Breztri Aerosphere achieved a 24% reduction (p<0.001) in exacerbations. |
| 2020-06-05 | Novartis Pharmaceuticals | Results Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma novartis.com ↗
Once-daily Enerzair ® Breezhaler ® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving quality of life in people with uncontrolled asthma 1 . |
| 2020-05-01 | Novartis Pharmaceuticals | Regulatory Novartis receives CHMP positive opinion for Enerzair® Breezhaler® (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma novartis.com ↗ |
| 2019-09-30 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III IRIDIUM study of inhaled combination QVM149 in patients with uncontrolled asthma novartis.com ↗
Once-daily QVM149 demonstrated statistically significant improvement in lung function versus QMF149, meeting primary endpoint[1],[2] |
| 2019-06-19 | AstraZeneca | Regulatory Breztri Aerosphere (PT010) approved in Japan for patients with chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that Breztri Aerosphere (budesonide/glycopyrronium/ formoterol fumarate), formerly PT010, has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD). |
| 2019-06-19 | AstraZeneca | Regulatory Bevespi Aerosphere approved by the Japanese Ministry of Health, Labour and Welfare for patients with chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that Bevespi Aerosphere (glycopyrronium/formoterol fumarate) has been approved in Japan as a fixed-dose, long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive pulmonary disease (COPD). |
| 2018-12-20 | AstraZeneca | Regulatory Bevespi Aerosphere approved in the EU for chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced that the European Commission (EC) has approved Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2018-09-16 | AstraZeneca | Results The Lancet Respiratory Medicine publishes first Phase III trial for PT010 triple combination therapy in moderate to very severe chronic obstructive pulmonary disease astrazeneca.com ↗
PT010 also demonstrated reductions in the rate of moderate or severe COPD exacerbations versus PT009 and Symbicort (18% and 17% respectively), which were numerically but not statistically significant improvements. |
| 2018-08-23 | AstraZeneca | Results AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere in chronic obstructive pulmonary disease astrazeneca.com ↗
AstraZeneca today announced top-line results from the AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). |
| 2018-01-26 | AstraZeneca | Results AstraZeneca reports top-line Phase III KRONOS trial results for PT010 triple combination therapy in chronic obstructive pulmonary disease astrazeneca.com ↗
PT010 demonstrates significant improvement in six out of seven lung function primary endpoints compared with dual combination therapies |
| 2017-11-28 | Nxera Pharma UK Limited | Results New data showed Ultibro Breezhaler significantly improved COPD patients’ lung function after direct switch from Seretide nxera.life ↗
The study met the primary endpoint demonstrating that switching patients to Ultibro ® Breezhaler® resulted in significantly improved lung function (trough FEV1)1. |
| 2017-11-27 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® significantly improved COPD patients' lung function after direct switch from Seretide® novartis.com ↗
Novartis today announced positive results from the FLASH** study examining the safety and efficacy of directly switching chronic obstructive pulmonary disease (COPD) patients from Seretide ® (salmeterol/fluticasone) 50/500 mcg to Ultibro ® Breezhaler ® (indacaterol/glycopyrronium) 110/50 mcg[1]. |
| 2016-09-03 | Novartis Pharmaceuticals | Results Novartis' Ultibro® Breezhaler® consistently more effective than Seretide®* in reducing COPD flare-ups across different patient groups novartis.com ↗
New analyses from the head-to-head FLAME study confirmed that Ultibro ® Breezhaler ® is a more effective option for patients at risk of chronic obstructive pulmonary disease (COPD) flare-ups (exacerbations) than Seretide ® , across different patient sub-groups[1-10]. |
| 2016-08-30 | AstraZeneca | Results AstraZeneca to present new data highlighting its growing respiratory portfolio and pipeline at European Respiratory Society 2016 astrazeneca.com ↗
The benefit of Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) over a 24-hour period versus tiotropium bromide inhalation spray and placebo (abstract #PA994) |
| 2016-05-16 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2016-05-16 | Nxera Pharma UK Limited | Results Major study published in NEJM confirms Ultibro Breezhaler superiority over Seretide in preventing COPD exacerbations nxera.life ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes 1. |
| 2016-05-15 | Novartis Pharmaceuticals | Results Major study published in NEJM confirms Novartis' Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations novartis.com ↗
In addition to meeting the primary endpoint (non-inferiority), findings demonstrated the superiority of Ultibro Breezhaler over the widely used inhaled corticosteroid (ICS)/LABA* combination on exacerbation outcomes[1]. |
| 2015-11-17 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2015-11-17 | Nxera Pharma UK Limited | Results FLAME Study Shows Superiority of Ultibro Breezhaler over Seretide in Reducing COPD Exacerbations nxera.life ↗ |
| 2015-10-30 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2015-10-30 | Nxera Pharma UK Limited | Regulatory Sosei confirms FDA approvals of new dual combination bronchodilator Utibron Neohaler and monotherapy Seebri Neohaler for patients with chronic obstructive pulmonary disease nxera.life ↗
The FDA also approved Seebri™ Neohaler® (glycopyrrolate) inhalation powder 15.6 mcg – which is one component of Utibron Neohaler – as a stand-alone monotherapy for COPD. |
| 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, open-label study 201315 showed thatumeclidinium 62.5mcg once daily was non-inferior to glycopyrronium 44mcg administered once daily, also measured by trough FEV1 at 12 weeks. |
| 2015-05-21 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2015-05-21 | Nxera Pharma UK Limited | Results Two positive US phase III programs in COPD for QVA149 and NVA237 nxera.life ↗
GEM 1 & 2 studies showed NVA237 provided significant and clinically meaningful improvements in lung function in moderate-to-severe COPD patients8,9 |
| 2015-05-20 | Novartis Pharmaceuticals | Results Novartis announces two positive US phase III programs in COPD for QVA149 and NVA237 novartis.com ↗ |
| 2015-03-18 | AstraZeneca | Results AstraZeneca announces positive Phase III top-line results for PT003 from PINNACLE 1 and PINNACLE 2 studies in COPD astrazeneca.com ↗
Both PT001 and PT005 also demonstrated statistically significant improvements in trough FEV1 compared to placebo. |
| 2015-03-06 | Nxera Pharma UK Limited | Regulatory U.S. FDA filing acceptance of NDAs for QVA149 and NVA237 nxera.life ↗
U.S. FDA filing acceptance of NDAs for QVA149 and NVA237 |
| 2015-01-08 | Novartis Pharmaceuticals | Results Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA novartis.com ↗
The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints. |
| 2015-01-08 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2015-01-08 | Nxera Pharma UK Limited | Regulatory Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237 nxera.life ↗
Submissions to US FDA complete for QVA149 and NVA237 in Q4 2014 |
| 2014-09-08 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2014-09-08 | Nxera Pharma UK Limited | Results Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro Breezhaler and Seebri Breezhaler, and promotion agreement with Pfizer in the UK nxera.life ↗
Glycopyrronium once-daily significantly improves lung function and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study. |
| 2014-05-21 | Nxera Pharma UK Limited | Results Positive results at ATS for once-daily Ultibro Breezhaler versus combination therapy (tiotropium plus formoterol) nxera.life ↗ |
| 2014-04-30 | Nxera Pharma UK Limited | Results Once-daily Ultibro Breezhaler showed superior efficacy versus Seretide for COPD patients in second head-to-head study, and the anticipated timing of China filing nxera.life ↗
Ultibro Breezhaler met both the primary and key secondary objectives. |
| 2013-09-23 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) approved for the treatment of COPD in Europe nxera.life ↗
European Commission approved once-daily Ultibro ® Breezhaler® (indacaterol 85 mcg / glycopyrronium 43 mcg) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). |
| 2013-09-20 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Inhalation Capsules (QVA149) approved for the treatment of COPD in Japan nxera.life ↗
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved once-daily Ultibro ® Inhalation Capsules (glycopyrronium 50 mcg / indacaterol 110 mcg) |
| 2013-09-09 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-09-09 | Nxera Pharma UK Limited | Results Data at ERS further demonstrates efficacy of once-daily Ultibro Breezhaler (QVA149) and Seebri Breezhaler (glycopyrronium bromide) nxera.life ↗
SPARK study showed similar rates of reduction in exacerbations with once-daily Seebri® Breezhaler® (glycopyrronium bromide) and open-label tiotropium 18 mcg in patients with severe-to-very severe COPD4,5 |
| 2013-07-27 | Nxera Pharma UK Limited | Regulatory First in class once-daily dual bronchodilator Ultibro Breezhaler (QVA149) gains positive CHMP opinion for the treatment of COPD nxera.life ↗
QVA149 (indacaterol/glycopyrronium) is the first once-daily fixed-dose combination of both a LABA and a LAMA bronchodilator to gain positive CHMP opinion |
| 2013-05-22 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-05-22 | Nxera Pharma UK Limited | Results New data reinforces strength of once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations nxera.life ↗ |
| 2012-10-10 | Nxera Pharma UK Limited | Regulatory Seebri Breezhaler receives European Commission approval as once-daily maintenance treatment for COPD in the EU nxera.life ↗
Seebri® Breezhaler® receives European Commission approval as once-daily maintenance treatment for COPD in the EU |
| 2012-10-01 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2012-09-28 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2012-09-28 | Nxera Pharma UK Limited | Regulatory Seebri Inhalation Capsules receive MHLW approval as once-daily maintenance treatment for COPD in Japan nxera.life ↗
This marks the first approval for glycopyrronium, with approval also expected in the EU in 2012, and triggers a $2.5m milestone payment to Sosei. |
| 2012-09-03 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2012-09-03 | Nxera Pharma UK Limited | Results Data at ERS shows efficacy of once-daily COPD portfolio versus comparators, further establishes dual-bronchodilator QVA149 nxera.life ↗
Data from the GLOW program showed that glycopyrronium 50 mcg once daily provided rapid and sustained bronchodilation, and reduced exacerbations and symptoms when compared to placebo, similar to the levels observed with open-label (OL) tiotropium 18 mcg3,4. |
| 2012-08-28 | Nxera Pharma UK Limited | Results QVA149 Phase III study meets primary endpoint in reducing exacerbations in COPD patients and filings in EU and Japan by end of year nxera.life ↗ |
| 2012-06-23 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 2012-06-23 | Nxera Pharma UK Limited | Regulatory Once-daily Seebri Breezhaler receives positive CHMP opinion to treat COPD patients in the EU nxera.life ↗
This positive opinion for Seebri Breezhaler is a value enhancing milestone for both Sosei and its co-development partner Vectura. |
| 2012-05-17 | Nxera Pharma UK Limited | Results NVA237 Phase III GLOW2 data at American Thoracic Society (ATS) International Conference and Phase II clinical trial update nxera.life ↗
GLOW2 met its primary endpoint by demonstrating NVA237 provided superior 24 -hour bronchodilation compared to p lacebo at 12 weeks measured by mean trough FEV1 (97 mL; p<0.001). |
| 2011-11-25 | Nxera Pharma UK Limited | Regulatory Novartis files NDA for NVA237 as a treatment for chronic obstructive pulmonary disease (COPD) in Japan nxera.life ↗ |
| 2011-09-27 | Nxera Pharma UK Limited | Regulatory NVA237 filed in Europe and positive Phase III data at European Respiratory Society Congress nxera.life ↗
NVA237 has been filed for marketing authorisation by Novartis with the European Medicines Agency (EMA) under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei |
| 2011-06-30 | Nxera Pharma UK Limited | Results Phase III study shows once-daily NVA237 is superior to placebo and similar to tiotropium in improving lung function in COPD nxera.life ↗
GLOW2 study shows NVA237 provides superior 24-hour bronchodilation to placebo (p＜0.001) with comparable efficacy to open-label tiotropium at 12 weeks |
| 2011-04-19 | Nxera Pharma UK Limited | Results Phase III data show NVA237 significantly improves lung function with good safety profile in COPD patients nxera.life ↗
The pivotal double-blind 26-week GLOW1 study met its primary endpoint by demonstrating superior bronchodilation to placebo at 12 weeks measured by trough FEV1 (i.e. forced expiratory volume in one second), a standard measure of lung function (p<0.001). |
| 2008-10-07 | Nxera Pharma UK Limited | Results NVA237 Phase II results presented at the European Respiratory Society Annual Meeting show promising efficacy and tolerability with potentially faster onset than tiotropium. nxera.life ↗
The new data show that NVA237 (glycopyrronium bromide), a novel inhaled long-acting muscarinic antagonist (LAMA), provides sustained 24-hour bronchodilation in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). |
All press releases naming this drug 85 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 133 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glycopyrronium | “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 ↗97“A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) Versus Placebo in Participants of 4 to...” NCT07525375 ↗ “The investigators will compare the reduction in Borg dyspnea score during the 3-min constant rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg...” NCT02567214 ↗ “QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium...” PMID 23867808 ↗ Jul 2013 “We randomly assigned participants (1:1) to either receive a combined inhaled dual bronchodilator containing the LABA indacaterol (110 μg as maleate salt) plus the LAMA...” PMID 29477448 ↗ Feb 2018 “HL231 Solution for Inhalation, 3ml:261 μg/141μg, once per day via PARI BOY nebulizer, consisting of a fixed dose combination of indacaterol 261µg and glycopyrronium 141µg,...” NCT06643078 ↗ “The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in...” NCT02233543 ↗ “Primary objectives were to assess total systemic exposure (without charcoal) and lung exposure (with charcoal) of budesonide, glycopyrronium, and formoterol administered as BGF...” PMID 32253054 ↗ Apr 2020 “single-inhaler extrafine combination of beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF; long-acting β2 agonist), and glycopyrronium (G;...” PMID 31582314 ↗ Sep 2019 “We evaluated the effects of the long acting bronchodilator components of the extrafine single inhaler triple therapy beclometasone dipropionate/formoterol/glycopyrronium...” PMID 33298062 ↗ Dec 2020 “Effects of indacaterol/glycopyrronium (QVA149) on lung hyperinflation and physical activity in patients with moderate to severe COPD: a randomised, placebo-controlled,...” PMID 27301417 ↗ Jun 2016 |
| Known as | CHF5259 | “Single supra-therapeutic dose CHF5259 (GB)” NCT05830071 ↗ |
| Known as | GB | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05898984 ↗ |
| Known as | GLY | “once-daily umeclidinium bromide (UMEC) was compared with once-daily tiotropium (TIO) and once-daily glycopyrronium (GLY)” PMID 29773969 ↗ May 20181“free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 ↗ Jan 2017 |
| Known as | glycopyrrolate | “Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), formulated using co-suspension delivery technology” PMID 31267366 ↗ Jul 20191“glycopyrrolate (GP) MDI 18 μg” PMID 32450869 ↗ May 2020 |
| Known as | glycopyrrolate bromide | “or 4 mg dexamethasone and 4 mg tropisetron combined with 0.2 mg glycopyrrolate bromide (Group G).” PMID 40859968 ↗ Aug 2025 |
| Known as | glycopyrronium bromide | “CHF 5993 is an extrafine 'triple therapy' combination of the long-acting muscarinic antagonist glycopyrronium bromide (GB), the long-acting β2-agonist formoterol fumarate (FF),...” PMID 27209586 ↗ Apr 201734“This study aimed to establish optimal dosage of nebulized HL231 inhalation solution (HL231), comparable to Ultibro® (110 µg indacaterol maleate/50 µg glycopyrronium bromide),...” PMID 41229760 ↗ Oct 2025 “A Clinical Trial Comparing TQC3927 Inhaled Powder With Glycopyrronium Bromide and Formoterol Inhaled Aerosol (Biovoping® Lingchang®) for the Treatment of Chronic Obstructive...” NCT07633314 ↗ “Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator...” NCT00501852 ↗ “Glycopyrronium bromide, long-acting muscarinic antagonist (LAMA). Administered as 54 μg, 1 capsule inhaled once daily via Breezhaler device for 28 days in combination with indacaterol.” NCT07541378 ↗ “An extrafine formulation of the long-acting muscarinic antagonist, glycopyrronium bromide (GB), has been developed for delivery via the NEXThaler dry powder inhaler (DPI).” PMID 29872288 ↗ May 2018 “Active ingredients: Beclomethasone Dipropionate (BDP)//Formoterol Fumarate (FF) /Glycopyrronium Bromide (GB) 100/6/12,5μg per actuation; Excipients: HFA-152a propellant.” NCT07858123 ↗ “Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) Administered Via Pressurized Metered-dose Inhaler (pMDI)” NCT02467452 ↗ “Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose” NCT03197818 ↗ “Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis” NCT03037788 ↗ “Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233 ↗ |
| Known as | glycopyrronium tosylate | “Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%).” PMID 31111409 ↗ Aug 20191“Glycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years.” PMID 33433785 ↗ Jan 2021 |
| Known as | GP MDI | “glycopyrrolate (GP) MDI 18 μg” PMID 32450869 ↗ May 2020 |
| Known as | GPB | “Investigation of Ascending Concentrations of Glycopyrronium Bromide (GPB) in a Topical Formulation in Subjects With Axillary Hyperhidrosis” NCT03037788 ↗2“1% Glycopyrronium Bromide (GPB) Cream in Adolescents With Severe Primary Axillary Hyperhidrosis” NCT05863104 ↗ “1% Glycopyrronium Bromide (GPB)” NCT03658616 ↗ |
| Known as | NVA237 | “QVA149 is an inhaled, once-daily fixed-dose dual bronchodilator combination of the long-acting β2-agonist indacaterol and long-acting muscarinic antagonist glycopyrronium...” PMID 23867808 ↗ Jul 20138“This study purpose is to further study the profiles of glycopyrronium (NVA237) and tiotropium during the first hours after dosing and their impact on pulmonary function, COPD...” NCT01959516 ↗ “NVA237 is a once-daily dry-powder formulation of the long-acting muscarinic antagonist glycopyrronium bromide in development for the treatment of chronic obstructive pulmonary...” PMID 22151296 ↗ Dec 2011 “Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator...” NCT00501852 ↗ “Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233 ↗ “once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control” NCT01285492 ↗ “the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237)” PMID 24534204 ↗ Jan 2014 “NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules.” NCT01709864 ↗ “glycopyrronium (NVA237)” NCT01202188 ↗ |
| Known as | PT001 | “Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)” NCT02343458 ↗1“Glycopyrronium (PT001)” NCT02433834 ↗ |
| Known as | Qbrexza | “Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%).” PMID 31111409 ↗ Aug 20192“Glycopyrronium tosylate (GT; Qbrexza® [glycopyrronium] cloth, 2.4%) is a topical anticholinergic approved (USA) for primary axillary hyperhidrosis in patients aged ≥ 9 years.” PMID 33433785 ↗ Jan 2021 “Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use” NCT04159610 ↗ |
| Known as | Sialanar | “Sialanar - a licensed glycopyrronium bromide product” NCT04873115 ↗ |
| Action | Inhibit | “a once-daily long-acting muscarinic antagonist” PMID 20541381 ↗ Jun 2010 |
| Route | Inhaled | “Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI)” NCT00929110 ↗ |