Glycopyrronium
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | QBREXZA | — | 2018-06-28 | fda.gov ↗ |
| Approved | EU (EMA) | Enurev Breezhaler | — | 2012-09-28 | europa.eu ↗ |
Trials 96 · started per year
Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06297668 Comparator | Apr → Jun 2024 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02287272 Comparator | May → Jul 2014 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07633314 Comparator | Jul → Dec 2026 expected | chronic obstructive pulmonary disease | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04937543 Comparator | Jun → Oct 2021 | COVID-19 | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 2 | NCT04159610 Comparator | Dec 2019 → Oct 2020 | isolated hyperchlorhidrosis | Dr. August Wolff GmbH & Co. KG Arzneimittel | Withdrawn | No outcome recorded |
| Phase 2 | NCT03880266 Comparator | Feb → May 2019 | hyperhidrosis palmaris ET plantaris | Journey Medical Corporation | Completed | No outcome recorded |
| Phase 2 | NCT03256552 Comparator | Jan → Sep 2015 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02129660 Comparator | Apr 2014 → Jan 2015 | — | Journey Medical Corporation | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT06234345 Comparator | Sep 2026 → Aug 2028 expected | chronic obstructive pulmonary disease | Eurofarma Laboratorios S.A. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06283966 Background | Feb 2024 → Dec 2027 expected | chronic obstructive pulmonary disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06067828 Comparator | Oct 2023 → Jan 2026 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03836677 Background | Feb → Nov 2019 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03379233 Background | Jul 2018 → Jan 2019 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01996319 Comparator | Apr 2014 → Feb 2015 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01699685 Comparator | Nov 2012 → Jun 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01202188 Comparator | Sep 2010 → Feb 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01120691 Comparator | Apr 2010 → Jul 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07666490 Comparator | Jun 2026 → Jun 2028 expected | asthma | Chiesi Farmaceutici S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04873115 Comparator | May 2021 → Dec 2022 | neurodevelopmental disorder | Proveca Pharma Limited | Unknown | No outcome recorded |
| Phase 4 | NCT04737655 Comparator | Feb 2021 → Feb 2023 | chronic obstructive pulmonary disease | PARZIBUT Gilles | Unknown | No outcome recorded |
| Phase 4 | NCT03229486 Comparator | Mar 2017 → Jul 2019 | delirium | Pusan National University Yangsan Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02009306 Background | Jan 2017 → Feb 2018 | — | Gloucestershire Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase not applicable3 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 |
| — | NCT04675463 Background | Dec 2020 → Jan 2023 | chronic obstructive pulmonary disease | ShiYue Li | Unknown | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2015-05-20 | Novartis Pharmaceuticals | Novartis announces two positive US phase III programs in COPD for QVA149 and NVA237 novartis.com ↗ |
| 2015-01-08 | Novartis Pharmaceuticals | Novartis announces robust Phase III results for QVA149 and NVA237 and submits regulatory applications to US FDA novartis.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 132 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 “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 “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 “This Phase IIb study investigated the safety and efficacy of four doses of the LAMA glycopyrronium (GP) delivered using co-suspension delivery technology via metered dose inhaler (MDI).” PMID 29506504 ↗ Mar 2018 “Efficacy and safety of the direct switch to indacaterol/glycopyrronium from salmeterol/fluticasone in non-frequently exacerbating COPD patients: The FLASH randomized controlled trial.” PMID 30074294 ↗ Aug 2018 “Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)” NCT02347085 ↗ “Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)” NCT02347072 ↗ “Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)” NCT02685293 ↗ “Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)” NCT02343458 ↗ “Placebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®” NCT05776927 ↗ “once-daily QVA149 (fixed-dose combination of indacaterol 110 μg and glycopyrronium 50 μg), glycopyrronium 50 μg, or tiotropium 18 μg” PMID 24429126 ↗ Apr 2013 “QVM149 is an investigational drug consisting of 150μg indacaterol acetate, 50μg glycopyrronium bromide and 160μg mometasone furoate.” NCT04206761 ↗ “Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler” NCT03379233 ↗ “A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI)” NCT06297668 ↗ “QVM149 150/50/160 μg (indacaterol acetate/glycopyrronium/mometasone furoate) once daily (o.d.) delivered via Concept1 device” NCT02571777 ↗ “HL231 261 µg/141 µg demonstrated peak concentration (Cmax) of indacaterol and glycopyrronium at 86% and 54% of Ultibro®” PMID 41229760 ↗ Oct 2025 “Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler” NCT02497001 ↗ “Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries” PMID 27715335 ↗ Aug 2016 “Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium in Patients with COPD” PMID 33488071 ↗ Jan 2021 “Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time” NCT04675463 ↗ “Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010” NCT03262012 ↗ “Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension” NCT06283966 ↗ “Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFO” NCT06723756 ↗ “Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)” NCT03081247 ↗ “QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1” NCT01285492 ↗ “free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 ↗ Jan 2017 “Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol” NCT04259164 ↗ “Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler” NCT04609904 ↗ “budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler” NCT04609878 ↗ “Indacaterol-Glycopyrronium (110ug/50ug QD inhalation) for one year.” NCT04509661 ↗ “Indacaterol acetate / glycopyrronium bromide / mometasone furoate” NCT03158311 ↗ “Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF)” NCT06075095 ↗ “budesonide/formoterol/glycopyrronium 160/7.2/4.8 mcg” NCT07329946 ↗ “Budesonide, Glycopyrronium, and Formoterol Fumarate” NCT05573464 ↗ “Budesonide, Glycopyrronium, and Formoterol Fumarate” NCT02536508 ↗ “Budesonide, Glycopyrronium and Formoterol Fumarate.” NCT03906045 ↗ “Treatment with Glycopyrronium/Formoterol Fumarate” NCT03836677 ↗ “the LAMA glycopyrronium (50 μg) once daily” PMID 27181606 ↗ May 2016 “* Glycopyrronium * Hyoscine butylbromide” NCT02009306 ↗ “Glycopyrronium and Formoterol Fumarate” NCT02643082 ↗ “Glycopyrronium” NCT03662711 ↗ “Glycopyrronium” NCT02937584 ↗ |
| 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 201733“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 “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 ↗ “fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide” NCT02676089 ↗ “once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control” NCT01285492 ↗ “BDP=Beclometasone Dipropionate 100µg; FF=Formoterol Fumarate 6µg; GB=Glycopyrronium Bromide 12.5µg.” NCT02676076 ↗ “BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg” NCT07301736 ↗ “Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients” NCT02442206 ↗ “Glycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri” NCT02181023 ↗ “NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules.” NCT01709864 ↗ “Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of” PMID 40859968 ↗ Aug 2025 “free combination of indacaterol maleate (IND) and glycopyrronium bromide (GLY)” PMID 28077140 ↗ Jan 2017 “beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide” PMID 28385353 ↗ Apr 2017 “beclometasone dipropionate /formoterol fumarate/glycopyrronium bromide” NCT05830071 ↗ “Drug: Indacaterol maleate and glycopyrronium bromide” NCT04856098 ↗ “Sialanar - a licensed glycopyrronium bromide product” NCT04873115 ↗ “indacaterol and glycopyrronium bromide (QVA149)” NCT01294787 ↗ “1% Glycopyrronium Bromide (GPB)” NCT03658616 ↗ “GB (Glycopyrronium Bromide)” NCT05898984 ↗ |
| 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 ↗ |