Drugs / Glycopyrrolate
Glycopyrrolate
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| Filed | EU (EMA) | — | asthma | — | “was submitted for registration in Europe in May 2019 and in Japan in Q3 2019.” nxera.life ↗ |
| Filed | Japan (PMDA) | — | asthma | — | “was submitted for registration in Europe in May 2019 and in Japan in Q3 2019.” nxera.life ↗ |
| Filed chronic obstructive pulmonary disease 2 milestones | |||||
| 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 ↗ “NVA237 is under regulatory review in the EU, where it was submitted for approval in September 2011 under the brand name Seebri ® Breezhaler®.” nxera.life ↗ “ノバルティス社がSeebri® Breezhaler®の製品名で NVA237 の欧州での承認申請を提出した。” nxera.life ↗ |
| Filed | Japan (PMDA) | — | chronic obstructive pulmonary disease | — | “In Japan, Novartis submitted NVA237 for approval in November 2011” nxera.life ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | GLYRX-PF | — | 2025-07-16 | fda.gov ↗ |
| Approved | US (FDA) | ROBINUL FORTE | — | 1961-08-11 | fda.gov ↗ |
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06351852 | Mar 2022 → Sep 2024 | constipation disorder, neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT04027972 | Mar 2020 → Dec 2022 | constipation disorder, neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 0 | NCT02370862 | Feb 2013 → Dec 2016 | neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT04600505 | Oct 2020 → May 2021 | chronic obstructive pulmonary disease | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04671030 | Jan → Jun 2018 | constipation disorder, neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03250182 | Aug → Dec 2017 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03004495 | Jan → Aug 2016 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT02512302 | Oct 2015 → Apr 2016 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02197975 | Aug → Oct 2014 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02119234 | Mar 2014 → Feb 2015 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 1 | NCT02370433 | Dec 2012 → Jun 2018 | neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Unknown | No outcome recorded |
| Phase 1 | NCT01588717 | Apr 2012 → Jun 2016 | depressive disorder | Thomas Jefferson University | Terminated | No outcome recorded |
| Phase 1 | NCT01613690 | Jun → Nov 2010 | impaired renal function disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00893971 | May → Jul 2009 | — | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00545311 | Jul → Oct 2007 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 1/26 trials · 2 met primary | ||||||
| Phase 1/2 | NCT06841640 | Jan → May 2025 | chronic obstructive pulmonary disease | AeroRx Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT06041984 | Oct 2023 → Apr 2024 | — | Jie Chen | Unknown | No outcome recorded |
| Phase 1/2 | NCT06045364 | Oct 2023 → Jul 2024 | — | Jie Chen | Completed | No outcome recorded |
| Phase 1/2 | NCT06110403 | Sep 2023 → Sep 2026 overdue | chronic obstructive pulmonary disease | University Hospital, Lille | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01176903 | Aug → Nov 2010 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 1/2 | NCT00871182 | Mar → Sep 2009 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 225 trials · 10 met primary | ||||||
| Phase 2 | NCT07132983 | Oct → Nov 2025 | chronic obstructive pulmonary disease | Verona Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT07016412 | Jul 2025 → Aug 2026 | chronic obstructive pulmonary disease | Verona Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06545500 | Aug 2024 → Jan 2025 | chronic obstructive pulmonary disease | Verona Pharma, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05116930 | Nov 2021 → Dec 2027 expected | intracranial hypotension | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT03084796 | Jul 2017 → May 2018 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT02296411 | Nov 2014 → Aug 2015 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT02189577 | Jun 2014 → Feb 2015 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT02127866 | Apr 2014 → Mar 2015 | asthma | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT02129660 | Apr 2014 → Jan 2015 | — | Journey Medical Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02016885 | Nov 2013 → Sep 2014 | — | Journey Medical Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01587079 | Apr → Sep 2012 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01476813 | Mar → Sep 2012 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Met primary |
| Phase 2 | NCT01566773 | Mar → Aug 2012 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01349816 | Jun → Nov 2011 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT01349803 | May → Nov 2011 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02948582 | Jul → Nov 2010 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | Met primary |
| Phase 2 | NCT01119950 | Apr → Dec 2010 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT01085045 | Mar → Nov 2010 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT02951312 | May → Jul 2009 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00856193 | Feb → May 2009 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00570778 | Dec 2007 → Sep 2008 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 2 | NCT00558285 | Nov 2007 → Jul 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00510510 | Aug 2007 → Jan 2008 | chronic obstructive pulmonary disease | Novartis | Completed | No outcome recorded |
| Phase 2 | NCT00315536 | May 2006 → Apr 2009 | — | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT00242333 | Oct 2005 → ? | chronic obstructive pulmonary disease | Sosei | Completed | No outcome recorded |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03137784 | May → Dec 2017 | asthma | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 318 trials · 5 met primary · 1 missed | ||||||
| Phase 3 | NCT06351995 | Nov 2020 → Oct 2022 overdue | constipation disorder, neurogenic bowel, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03116997 | Apr 2017 → Mar 2022 | — | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT02487498 | Jul 2015 → Sep 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT02127697 | Mar 2015 → May 2017 | asthma | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01837927 | Apr 2014 → Apr 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01917331 | Mar 2014 → Jan 2016 | chronic obstructive pulmonary disease | Chiesi Farmaceutici S.p.A. | Completed | Mixed |
| Phase 3 | NCT01970878 | Nov 2013 → Mar 2015 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01854658 | Jul 2013 → Mar 2015 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT01854645 | May 2013 → Feb 2015 | chronic obstructive pulmonary disease | Pearl Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01757015 | Apr 2013 → Apr 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 3 | NCT01715298 | Nov 2012 → Dec 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01697696 | Oct 2012 → Nov 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01613326 | Jun 2012 → Jan 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01513460 | Apr 2012 → Dec 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01566604 | Mar 2012 → Jun 2013 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01154127 | Jun 2010 → Feb 2011 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01119937 | May 2010 → Nov 2011 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00491894 | Mar 2007 → May 2008 | cerebral palsy | Shionogi | Completed | No outcome recorded |
| Phase 48 trials · 1 met primary · 3 missed | ||||||
| Phase 4 | NCT06531798 | Jan → Oct 2026 expected | chronic obstructive pulmonary disease | AstraZeneca | Recruiting | No outcome recorded |
| Phase 4 | NCT05970263 | Jan 2024 → Dec 2025 | chronic obstructive pulmonary disease | AstraZeneca | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05985343 | Jan 2024 → May 2025 | abdominal wall malformation, ileus | Clayton Petro | Completed | No outcome recorded |
| Phase 4 | NCT04401345 | Jun 2020 → Jan 2021 | — | Rajesh Deshar | Completed | Missed primary |
| Phase 4 | NCT04155047 | Nov 2019 → Mar 2020 | chronic obstructive pulmonary disease | Sunovion Respiratory Development Inc. | Completed | Missed primary |
| Phase 4 | NCT02371629 | Jun 2015 → Nov 2016 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 4 | NCT02872935 | May 2015 → Nov 2016 | — | Kokila N Thenuwara | Terminated | No outcome recorded |
| Phase 4 | NCT01922271 | Aug 2013 → Jan 2014 | chronic obstructive pulmonary disease | Novartis Pharmaceuticals | Completed | Met primary |
| Phase not applicable7 trials · 1 met primary | ||||||
| — | NCT05693246 | Oct 2023 → Jul 2024 | — | Zhuan Zhang | Completed | No outcome recorded |
| — | NCT06237478 | Mar → Jun 2023 | — | Zhuan Zhang | Completed | No outcome recorded |
| — | NCT05013320 | Sep 2021 → Dec 2022 | urinary bladder disorder | Kangbuk Samsung Hospital | Withdrawn | No outcome recorded |
| — | NCT05997004 | May 2018 → May 2019 | cardiac arrest | National Academy of Medical Sciences, Nepal | Completed | No outcome recorded |
| — | NCT03050242 | Mar → May 2017 | acute cholecystitis | Eunah Cho, MD | Completed | Met primary |
| — | NCT02228473 | Sep 2014 → Feb 2015 | urinary bladder neoplasm | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT02430272 | May → Nov 2014 | — | Inje University | Completed | No outcome recorded |
| Comparator or background therapy70 trials | ||||||
| Phase 1 | NCT07802730 Comparator | Sep → Dec 2026 expected | chronic obstructive pulmonary disease | AeroRx Therapeutics Inc. | Not yet recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 1/2 | NCT02613494 Comparator | Jan 2016 → Dec 2017 | — | Mersey Care NHS Trust | Completed | No outcome recorded |
| 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 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00473694 Comparator | Nov 2005 → Nov 2006 | — | Merck Sharp & Dohme LLC | Completed | Met primary |
| 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 Stop: Enrollment |
| 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 Stop: Business |
| Phase 4 | NCT05718934 Comparator | Nov 2022 → Dec 2023 | — | Ciusss de L'Est de l'Île de Montréal | Completed | Met primary |
| 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 | Met primary |
| 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 Stop: Business |
| 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 | Met primary |
| Phase 4 | NCT03346070 Comparator | Jan 2018 → Jan 2019 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT03346057 Comparator | Dec 2017 → Sep 2019 | — | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT03322657 Comparator | Nov 2017 → Dec 2020 | — | The Cleveland Clinic | Completed | Mixed |
| 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 | Missed primary |
| 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 |
| — | NCT06962007 Comparator | Jul 2025 → Sep 2026 overdue | 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 Stop: Enrollment |
| — | 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 |
News releases announcing trial results or a regulatory action · 61
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2020-09-07 | Nxera Pharma UK Limited | Results Sosei Heptares notes presentation of post hoc analysis showing high-dose Enerzair Breezhaler reduces asthma exacerbations versus medium-dose nxera.life ↗ |
| 2020-07-10 | Nxera Pharma UK Limited | Results Sosei Heptares notes publication of Ph3 IRIDIUM data in The Lancet Respiratory Medicine showing benefit of Enerzair Breezhaler in uncontrolled asthma nxera.life ↗ |
| 2020-07-07 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 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 ↗ |
| 2020-06-29 | Nxera Pharma UK Limited | Regulatory Sosei Heptares notes Enerzair approval in Japan - the world's first approval of this novel LABA/LAMA/ICS combination for treating bronchial asthma nxera.life ↗ |
| 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]. |
| 2017-05-24 | Nxera Pharma UK Limited | Results New analyses of FLAME study data reinforce the potential of Ultibro Breezhaler for COPD patients historically treated with steroids nxera.life ↗ |
| 2016-09-05 | Nxera Pharma UK Limited | Results New findings confirm UltibroR BreezhalerR is consistently more effective than SeretideR in reducing COPD flare-ups across different patient groups nxera.life ↗
Ultibro® Breezhaler ® reduced the rate of all COPD exacerbations across different patient sub-groups vs Seretide in new results from the FLAME study |
| 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 ↗ |
| 2016-05-15 | 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]. |
| 2016-04-25 | AstraZeneca | Regulatory Bevespi Aerosphere™ approved by the US FDA for patients with COPD astrazeneca.com ↗ |
| 2015-11-17 | Nxera Pharma UK Limited | Results Other 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. |
| 2015-05-21 | 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 Other nxera.life ↗ |
| 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). |
| 2013-09-09 | 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 |
| 2013-05-22 | 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 ↗ |
| 2013-04-24 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2013-04-24 | Nxera Pharma UK Limited | Results Seebri Breezhaler GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal nxera.life ↗
GLOW 5 met its primary endpoint and demonstrated the non-inferiority of Seebri ® Breezhaler® 50 mcg once-daily compared to tiotropi um 18 mcg once-daily as measured by trough FEV 1 at 12 weeks. |
| 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). |
| 2012-05-17 | Nxera Pharma UK Limited | Results Other nxera.life ↗ |
| 2011-11-25 | Nxera Pharma UK Limited | Regulatory Other nxera.life ↗ |
| 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 Other 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 Other nxera.life ↗ |
| 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 Other nxera.life ↗ |
| 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 Other nxera.life ↗ |
| 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). |
| 2006-06-28 | Nxera Pharma UK Limited | Results Other nxera.life ↗
当該試験において NVA237 は、肺機能の測定値で気管支拡張効果を示しました。 |
| 2006-06-28 | Nxera Pharma UK Limited | Results Sosei and Vectura Announce Successful Completion of Phase IIb Trial of NVA237 for COPD nxera.life ↗
NVA237 achieved statistical significance over placebo in terms of the primary efficacy variable, trough FEV1 and was comparable to tiotropium. |
All press releases naming this drug 78 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 154 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 2018116“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 “Comparison of Pharmacokinetics of Glycopyrrolate (AERO-002) in AERO-007 Combination Product Versus Active Comparator Inhalation Glycopyrrolate Product in Healthy Volunteers” NCT07802730 ↗ “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 ↗ |
| 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 ↗1“Comparison of Pharmacokinetics of Glycopyrrolate (AERO-002) in AERO-007 Combination Product Versus Active Comparator Inhalation Glycopyrrolate Product in Healthy Volunteers” NCT07802730 ↗ |
| Known as | CHF 5259 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02127866 ↗ |
| 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 NCT01613326 ↗ |
| 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 ↗ |