Glycopyrrolate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GLYRX-PF | — | 2025-07-16 | fda.gov ↗ |
| Approved | US (FDA) | ROBINUL FORTE | — | 1961-08-11 | fda.gov ↗ |
Trials 80 · started per year
Also used as a comparator or background therapy in 69 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT04554589 Comparator | Sep 2020 → Feb 2021 | — | Tanta University | Unknown | No outcome recorded |
| Phase 1 | NCT02574611 Comparator | Oct 2015 → Dec 2017 | digestive system disorder | James J. Peters Veterans Affairs Medical Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01398111 Comparator | May → Aug 2011 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT01176851 Comparator | Jul → Oct 2010 | — | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02613494 Comparator | Jan 2016 → Dec 2017 | — | Mersey Care NHS Trust | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03904550 Comparator | Dec 2019 → Aug 2022 | impaired renal function disease | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02382198 Comparator | Jul 2016 → Oct 2018 | Parkinson disease | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
| Phase 2 | NCT00855283 Background | Sep 2012 → Jun 2013 | — | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT03513406 Comparator | Mar 2018 → Mar 2023 | — | University of Kansas Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT02867761 Comparator | Aug 2017 → Jul 2021 | chronic obstructive pulmonary disease | University of Michigan | Completed | No outcome recorded |
| Phase 3 | NCT01712516 Comparator | Dec 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01727141 Comparator | Nov 2012 → Feb 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01604278 Comparator | May 2012 → Jan 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01529632 Comparator | May → Dec 2012 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01479764 Comparator | Dec 2011 → Oct 2012 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01422304 Background | Oct 2011 → Sep 2012 | blood coagulation disease, osteoarthritis, hip, osteoarthritis, knee | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT01050543 Background | Feb → Aug 2010 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00473694 Comparator | Nov 2005 → Nov 2006 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 432 trials | ||||||
| Phase 4 | NCT06112353 Comparator | Apr 2024 → Jul 2026 overdue | intestinal disorder | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 4 | NCT06282861 Comparator | Feb 2024 → Jan 2025 | chronic obstructive pulmonary disease | Fundacio Privada Mon Clinic Barcelona | Terminated | No outcome recorded |
| Phase 4 | NCT06228092 Comparator | Dec 2023 → May 2025 | curariform drugs toxicity | Matias Vested | Completed | No outcome recorded |
| Phase 4 | NCT05545280 Comparator | Dec 2023 → Aug 2024 | — | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT05887375 Comparator | Aug 2023 → Jan 2026 | urinary tract obstruction | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT05256901 Comparator | Jul 2023 → Jul 2024 | appendicitis | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT05718934 Comparator | Nov 2022 → Dec 2023 | — | Ciusss de L'Est de l'Île de Montréal | Completed | No outcome recorded |
| Phase 4 | NCT04606901 Comparator | Apr 2021 → Jul 2023 | chronic obstructive pulmonary disease | Temple University | Completed | No outcome recorded |
| Phase 4 | NCT04332627 Comparator | Feb → May 2020 | gallbladder disorder | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03909165 Comparator | Jul 2019 → Sep 2023 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT03939923 Comparator | May 2019 → Jul 2021 | coronary artery disorder | West Virginia University | Completed | No outcome recorded |
| Phase 4 | NCT02825576 Comparator | Dec 2018 → Apr 2020 | — | Northern Sydney Anaesthesia Research Institute | Terminated | No outcome recorded |
| Phase 4 | NCT03574337 Comparator | Aug 2018 | curariform drugs toxicity | Henry Ford Health System | Withdrawn | No outcome recorded |
| Phase 4 | NCT03513757 Background | Mar → Aug 2018 | epilepsy, headache disorder, hydrocephalus, neoplasm +1 | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 4 | NCT03351608 Comparator | Feb 2018 → Jan 2020 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT03346070 Comparator | Jan 2018 → Jan 2019 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT03346057 Comparator | Dec 2017 → Sep 2019 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT03322657 Comparator | Nov 2017 → Dec 2020 | — | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03168308 Comparator | Sep 2017 → Sep 2019 | — | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03138967 Comparator | Sep 2017 → Sep 2018 | urinary bladder cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 4 | NCT03580889 Comparator | Sep 2017 → Sep 2018 | — | B.P. Koirala Institute of Health Sciences | Unknown | No outcome recorded |
| Phase 4 | NCT03034577 Comparator | Jun 2017 → Feb 2019 | — | University of Melbourne | Completed | No outcome recorded |
| Phase 4 | NCT03111121 Comparator | May 2017 → Jun 2018 | — | West Virginia University | Completed | No outcome recorded |
| Phase 4 | NCT03081156 Comparator | Mar 2017 → Jan 2019 | chronic obstructive pulmonary disease | William Stringer, md | Completed | No outcome recorded |
| Phase 4 | NCT02996591 Comparator | Jan → May 2017 | peripheral nerve lesion | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 4 | NCT02860507 Comparator | Aug 2016 → Feb 2018 | — | University of South Florida | Completed | No outcome recorded |
| Phase 4 | NCT02327923 Comparator | Jan 2015 → Feb 2016 | gallstones | B.P. Koirala Institute of Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02375217 Comparator | Oct 2014 → Oct 2015 | — | American University of Beirut Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT01748643 Comparator | Apr 2013 → Jan 2015 | obesity disorder | Ziekenhuis Oost-Limburg | Completed | No outcome recorded |
| Phase 4 | NCT01453530 Comparator | Oct 2011 → Sep 2012 | — | Radboud University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01199237 Comparator | Aug 2010 → Aug 2012 | — | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01142648 Background | Apr 2009 → Mar 2010 | — | Tampere University Hospital | Completed | No outcome recorded |
| Phase not applicable19 trials | ||||||
| — | NCT06962007 Comparator | Jul 2025 → Sep 2026 expected | facial spasm | Wonkwang University Hospital | Recruiting | No outcome recorded |
| — | NCT06398899 Comparator | May 2024 → Jun 2025 | chronic otitis media, chronic rhinosinusitis, laryngeal disorder | National Taiwan University Hospital | Completed | No outcome recorded |
| — | NCT05993390 Background | Jan 2024 → Aug 2027 expected | — | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT04873531 Background | May → Aug 2021 | thyroid gland disorder | Seoul National University Hospital | Completed | No outcome recorded |
| — | NCT04205097 Comparator | Dec 2019 → Dec 2020 | gastric cancer | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT04407078 Comparator | Dec 2019 → Jan 2021 | gallbladder disorder | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT04022733 Background | Oct 2019 → Aug 2021 | abdominal wall malformation | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT03791801 Comparator | Sep 2019 → Dec 2020 | — | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| — | NCT03742141 Background | Oct 2018 → Jan 2022 | — | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| — | NCT03583021 Comparator | Jun → Oct 2018 | gallbladder disorder | Ajou University School of Medicine | Completed | No outcome recorded |
| — | NCT03322098 Comparator | Oct 2017 → May 2018 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT03322150 Comparator | Oct 2017 → Aug 2018 | — | Yonsei University | Terminated | No outcome recorded |
| — | NCT02726620 Background | Jan → Dec 2017 | hypotensive disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| — | NCT03357393 Background | Apr 2016 → May 2017 | — | Lena Nilsson | Completed | No outcome recorded |
| — | NCT02524145 Background | Jun 2015 → Nov 2017 | heart failure | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| — | NCT01980069 Background | Nov 2013 → Oct 2014 | — | Yonsei University | Completed | No outcome recorded |
| — | NCT02410460 Background | Sep 2013 → Jun 2014 | — | Mercy Facial Plastic Surgery Center | Completed | No outcome recorded |
| — | NCT01511627 Comparator | Jan → Jul 2012 | — | University of Saskatchewan | Withdrawn | No outcome recorded |
| — | NCT01191398 Comparator | Jun 2010 → Jan 2011 | — | Craig J. Huang | Completed | 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 18 cited values
Every value below carries the sentence it was read from. 153 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GLYCOPYRROLATE | “Glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA), glycopyrrolate (GP), and the...” PMID 29567116 ↗ Feb 2018115“BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9...” NCT06110403 ↗ “AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for...” NCT06841640 ↗ “neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing...” NCT01050543 ↗ “PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI).” PMID 28993871 ↗ Oct 2017 “with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)” NCT04332627 ↗ “In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.” NCT01980069 ↗ “For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.” NCT04873531 ↗ “PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.” NCT02197975 ↗ “Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI” NCT01970878 ↗ “Patient's will receive neostigmine/glycopyrrolate at the end of the case for reversal of neuromuscular blockade.” NCT03574337 ↗ “neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass)” NCT01748643 ↗ “Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline” NCT01142648 ↗ “fixed-dose combination of budesonide/glycopyrrolate/formoterol fumarate (BGF) 160/9/4.8 μg per actuation” PMID 37607661 ↗ Aug 2023 “Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg” NCT03034577 ↗ “Intravenous administration of neostigmine 0.05mg/kg with glycopyrrolate 0.01mg/kg” NCT05993390 ↗ “PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol.” NCT03250182 ↗ “Budesonide 160 mcg/Glycopyrrolate 7.2 mcg/Formoterol fumarate dehydrate 5 mcg” NCT06531798 ↗ “Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.” NCT04407078 ↗ “Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.” NCT03583021 ↗ “reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg” NCT04022733 ↗ “reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg” NCT04205097 ↗ “Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously” NCT01511627 ↗ “0.07 mg/kg Neostigmine plus 0.014 mg/kg glycopyrrolate” NCT06112353 ↗ “a long-acting muscarinic antagonist (glycopyrrolate)” PMID 26177074 ↗ Nov 2015 “For reversal, neostigmine with glycopyrrolate” NCT03904550 ↗ “glycopyrrolate (GP) MDI 18 μg” PMID 32450869 ↗ May 2020 “glycopyrrolate (GP) MDI 36 µg” PMID 29950826 ↗ Jun 2018 “glycopyrrolate (GLY) 25 µg” PMID 34232493 ↗ Jul 2021 “CHF 5259 (GLYCOPYRROLATE)” NCT02127866 ↗ “Glycopyrrolate Injection” NCT02512302 ↗ |
| Known as | AD 237 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00242333 ↗ |
| Known as | AERO-002 | “AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for...” NCT06841640 ↗ |
| Known as | CHF 5259 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03084796 ↗ |
| Known as | EP-101 | “AIMS: To establish the dose-response for pharmacodynamics (bronchodilatation), safety and pharmacokinetics for a nebulized formulation of the long acting muscarinic antagonist...” PMID 25243340 ↗ Mar 2015 |
| Known as | GLY | “A group of 6 able-bodied healthy volunteers will receive Neostigmine (NEO) and Glycopyrrolate (GLY) intravenously and via 2 methods of Iontophoresis (ION): one-patch and...” NCT04027972 ↗5“This will be followed by a 2 visit- dose titration study of concomitantly administered, transcutaneous neostigmine methylsulfate (NEO) and glycopyrrolate (GLY).” NCT02370433 ↗ “an ant-cholinergic known as Glycopyrrolate (GLY) is usually co-administered with NEO to reverse these side-effects.” NCT02574611 ↗ “a medication called neostigmine (NEO) combined with a medication called glycopyrrolate (GLY)” NCT02370862 ↗ “0.03mg/kg neostigmine (NEO) and 0.006mg/kg glycopyrrolate (GLY)” NCT04671030 ↗ “glycopyrrolate (GLY) 25 µg” PMID 34232493 ↗ Jul 2021 |
| Known as | Glycopyrrolate / Formoterol Inhaler vs Placebo Inhaler | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03081156 ↗ |
| Known as | glycopyrrolate bromide | “The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.” NCT02189577 ↗ |
| Known as | glycopyrrolate metered dose inhaler (GP MDI) | “glycopyrrolate metered dose inhaler (GP MDI)” NCT01854658 ↗ |
| Known as | Glycopyrronioum bromide | “NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules” NCT01715298 ↗ |
| Known as | glycopyrronium bromide | “The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide \[GB\]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo” NCT02296411 ↗4“We assessed the effects of glycopyrronium bromide (NVA237), a once-daily, long-acting muscarinic antagonist, on exercise tolerance in patients with moderate to severe COPD.” PMID 22973092 ↗ Jul 2012 “Glycopyrronium bromide (NVA237) is an inhaled long-acting muscarinic antagonist in development for treatment of COPD.” PMID 23217058 ↗ Dec 2012 “glycopyrronium bromide (NVA237) once daily for 28 days.” NCT01529632 ↗ “NVA237 (glycopyrronium bromide)” NCT03137784 ↗ |
| Known as | GP MDI | “Patients received GFF MDI 18/9.6 μg, glycopyrrolate (GP) MDI 18 μg, formoterol fumarate (FF) MDI 9.6 μg, or placebo MDI, twice-daily for 24 weeks.” PMID 32450869 ↗ May 2020 |
| Known as | NVA237 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03137784 ↗ |
| Known as | PT001 | “GP MDI (PT001)” NCT01970878 ↗ |
| Known as | Seebri | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06282861 ↗ |
| Action | Inhibit | “muscarinic antagonist” NCT01119950 ↗ |
| Modality | Small molecule | “Glycopyrrolate, as a quaternary amine, shows minimal penetration of the blood brain barrier” PMID 30905688 ↗ Mar 2019 |
| Route | Inhaled | “4 Doses of AD 237 Inhaled Once Daily for 28 Days” NCT00242333 ↗ |