Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate glycopyrrolate for diverse indications, including general anesthesia, chronic obstructive pulmonary disease, perioperative care, and reversal of neuromuscular blockade. Sponsored by academic institutions, university hospitals, and industry leaders like Merck Sharp & Dohme and Chiesi Farmaceutici, these active, recruiting, completed, and terminated studies examine its clinical utility across surgical and respiratory settings.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07282886 RECRUITING
Asthma
University of Alabama at Birmingham
 2026-03-15 PHASE2
NCT05116930 RECRUITING
Post-Dural Puncture Headache
Mayo Clinic
 2021-11-19 PHASE2
NCT07802730 NOT_YET_RECRUITING
COPD (Chronic Obstructive Pulmonary Disease)
AeroRx Therapeutics Inc.
 2026-09 PHASE1
NCT06962007 RECRUITING
Neuromuscular Blockade Reversal Agent; Perioperative Complications; Anesthesia, General; Sugammadex; Monitoring, Intraoperative; Masseter Muscle Spasm
Wonkwang University Hospital
 2025-07-01
NCT07016412 COMPLETED
Chronic Obstructive Pulmonary Disease
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
 2025-07-31 PHASE2
NCT06112353 COMPLETED
Intestinal Disease
University of California, Irvine
 2024-04-17 PHASE4
NCT05887375 COMPLETED
Spine Surgery; Reversal of Neuromuscular Blockade; Urinary Retention Postoperative
University of Missouri-Columbia
 2023-08-03 PHASE4
NCT05970263 WITHDRAWN
COPD
AstraZeneca
 2024-01-19 PHASE4
NCT07132983 COMPLETED
Chronic Obstructive Pulmonary Disease
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
 2025-10-06 PHASE2
NCT06398899 COMPLETED
Head and Neck Surgery; Chronic Sinusitis; Chronic Otitis Media; Laryngeal Disease
National Taiwan University Hospital
 2024-05-01
NCT05985343 COMPLETED
Hernia, Ventral; Ileus
Clayton Petro
 2024-01-15 PHASE4
NCT06228092 COMPLETED
Neuromuscular Blockade, Residual
Matias Vested
 2023-12-04 PHASE4
NCT06545500 COMPLETED
Chronic Obstructive Pulmonary Disease
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
 2024-08-16 PHASE2
NCT06351852 COMPLETED
Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2022-03-22 EARLY_PHASE1
NCT05545280 COMPLETED
Neuromuscular Blockade
The Cleveland Clinic
 2023-12-01 PHASE4
NCT05693246 COMPLETED
Glycopyrrolate
Zhuan Zhang
 2023-10-01
NCT06045364 COMPLETED
Nausea and Vomiting
Jie Chen
 2023-10-01 PHASE1; PHASE2
NCT05256901 TERMINATED
Appendicitis; Surgery
Emory University
 2023-07-19 PHASE4
NCT05664633 WITHDRAWN
Postoperative Urinary Retention
West Virginia University
 2023-08 PHASE1; PHASE2
NCT06291363 Not yet recruiting
Opioid Use Unspecified|Anesthesia|Nociceptive Pain
Ciusss de L''Est de l''Île de Montréal
 2024-04-04 Phase 4
NCT06041984 UNKNOWN
Glycopyrrolate; Colonoscopy
Jie Chen
 2023-10-08 PHASE1; PHASE2
NCT05718934 COMPLETED
Neuromuscular Blockade
Ciusss de L'Est de l'Île de Montréal
 2022-11-08 PHASE4
NCT03909165 COMPLETED
Neuromuscular Blockade
Merck Sharp & Dohme LLC
 2019-07-23 PHASE4
NCT04606901 COMPLETED
Neuromuscular Blockade; Chronic Obstructive Pulmonary Disease
Temple University
 2021-04-08 PHASE4
NCT06237478 COMPLETED
Glycopyrrolate
Zhuan Zhang
 2023-03-01
NCT03513406 COMPLETED
Burns
University of Kansas Medical Center
 2018-03-15 PHASE3
NCT05013320 WITHDRAWN
Bladder Irritable
Kangbuk Samsung Hospital
 2021-09-01
NCT04027972 COMPLETED
Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2020-03-09 EARLY_PHASE1
NCT06351995 ACTIVE_NOT_RECRUITING
Spinal Cord Injuries; Constipation; Fecal Incontinence; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2020-11-06 PHASE3
NCT03116997 COMPLETED
Surgery
Memorial Sloan Kettering Cancer Center
 2017-04-07 PHASE3
NCT03742141 COMPLETED
Vocal Cord Function in Neck Procedures
Icahn School of Medicine at Mount Sinai
 2018-10-17
NCT04979039 Unknown status
Cesarean Section
Seoul National University Bundang Hospital
 2021-08-01 --
NCT03939923 COMPLETED
Surgery; Coronary Artery Disease
West Virginia University
 2019-05-01 PHASE4
NCT02867761 COMPLETED
COPD (Chronic Obstructive Pulmonary Disease)
University of Michigan
 2017-08-29 PHASE3
NCT04554589 UNKNOWN
Effect of Drugs
Tanta University
 2020-09-14 PHASE1
NCT04401345 COMPLETED
Glycopyrrolate; Post-spinal Hypotension; Effect of Drug; Hemodynamic Instability
Rajesh Deshar
 2020-06-01 PHASE4
NCT03322657 COMPLETED
Neuromuscular Blockade; Anesthesia
The Cleveland Clinic
 2017-11-14 PHASE4
NCT03791801 UNKNOWN
Critical Illness
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2019-09-01
NCT04554589 Unknown status
Effect of Drugs
Tanta University
 2020-09-14 Phase 1
NCT01768780 UNKNOWN
Orthopedic Surgery-lower Leg Surgery
Yonsei University
 2012-12
NCT02825576 TERMINATED
Pulmonary Complications
Northern Sydney Anaesthesia Research Institute
 2018-12-03 PHASE4
NCT04155047 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Sunovion Respiratory Development Inc.
 2019-11-07 PHASE4
NCT03351608 COMPLETED
Neuromuscular Blockade
Merck Sharp & Dohme LLC
 2018-02-12 PHASE4
NCT03324607 COMPLETED
COPD
Bastiaan Driehuys
 2018-04-20 PHASE2; PHASE3
NCT03168308 COMPLETED
Neuromuscular Blockade
University of Texas Southwestern Medical Center
 2017-09-26 PHASE4
NCT03346057 COMPLETED
Reversal of Neuromuscular Blockade
Merck Sharp & Dohme LLC
 2017-12-20 PHASE4
NCT03229486 COMPLETED
Emergence Delirium
Pusan National University Yangsan Hospital
 2017-03-01 PHASE4
NCT05997004 COMPLETED
Bradyarrhythmia; Cardiac Arrest; Tachycardia; Asystole
National Academy of Medical Sciences, Nepal
 2018-05-01
NCT03346070 COMPLETED
Neuromuscular Blockade
Merck Sharp & Dohme LLC
 2018-01-01 PHASE4
NCT03081156 COMPLETED
Pulmonary Disease, Chronic Obstructive
William Stringer, md
 2017-03-27 PHASE4
NCT02382198 UNKNOWN
Sialorrhea; Parkinson's Disease
Ottawa Hospital Research Institute
 2016-07 PHASE2
NCT03138967 COMPLETED
Malignant Neoplasms of Urinary Tract; Bladder Cancer
M.D. Anderson Cancer Center
 2017-09-18 PHASE4
NCT03580889 UNKNOWN
Lower Extremity Fracture
B.P. Koirala Institute of Health Sciences
 2017-09-15 PHASE4
NCT03513757 COMPLETED
Headache; Tumor; Seizure Disorder; Neurofibromatoses; Hydrocephalus; Abdominal Neoplasm; Spine Deformity
Medical College of Wisconsin
 2018-03-04 PHASE4
NCT03322150 TERMINATED
Spinal Anesthesia
Yonsei University
 2017-10-01
NCT03111121 COMPLETED
Microlaryngoscopy; Rigid Bronchoscopy
West Virginia University
 2017-05-04 PHASE4
NCT04671030 COMPLETED
Spinal Cord Injuries; Constipation; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2018-01-15 PHASE1
NCT02370433 UNKNOWN
Spinal Cord Injury; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2012-12 PHASE1
NCT03322098 COMPLETED
Spinal Anesthesia
Yonsei University
 2017-10-16
NCT02860507 COMPLETED
Neuromuscular Blockade
University of South Florida
 2016-08 PHASE4
NCT02726620 COMPLETED
Hypotension
Vanderbilt University Medical Center
 2017-01-05
NCT02613494 COMPLETED
Sialorrhea
Mersey Care NHS Trust
 2016-01-25 PHASE1; PHASE2
NCT02574611 WITHDRAWN
Gastrointestinal Dysfunction
James J. Peters Veterans Affairs Medical Center
 2015-10-13 PHASE1
NCT02524145 COMPLETED
Heart Failure
University of Texas Southwestern Medical Center
 2015-06
NCT03050242 COMPLETED
Cholecystitis, Acute
Eunah Cho, MD
 2017-03-13
NCT03357393 COMPLETED
Sedation, Bronchoscopy
Lena Nilsson
 2016-04-04
NCT02996591 COMPLETED
Nerve Block; General Anesthesia; Spinal Anesthesia; Pain; Postoperative Nausea and Vomiting
Hospital for Special Surgery, New York
 2017-01 PHASE4
NCT02370862 COMPLETED
Spinal Cord Injury; Neurogenic Bowel
James J. Peters Veterans Affairs Medical Center
 2013-02 EARLY_PHASE1
NCT02872935 TERMINATED
Nausea; Vomiting
Kokila N Thenuwara
 2015-05-15 PHASE4
NCT01588717 TERMINATED
Hyperhydrosis; Depression
Thomas Jefferson University
 2012-04 PHASE1
NCT02512302 COMPLETED
COPD
Sunovion Respiratory Development Inc.
 2015-10 PHASE1
NCT01911364 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2014-01 PHASE3
NCT02327923 COMPLETED
Gall Stone Disease
B.P. Koirala Institute of Health Sciences
 2015-01 PHASE4
NCT02276222 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Sunovion Respiratory Development Inc.
 2014-10 PHASE3
NCT01917331 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Chiesi Farmaceutici S.p.A.
 2014-03-21 PHASE3
NCT02347774 COMPLETED
COPD; Chronic Obstructive Pulmonary Disease
Sunovion Respiratory Development Inc.
 2015-02 PHASE3
NCT02347761 COMPLETED
COPD
Sunovion Respiratory Development Inc.
 2015-02 PHASE3
NCT02375217 COMPLETED
Anesthesia Recovery
American University of Beirut Medical Center
 2014-10 PHASE4
NCT02296411 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2014-11-21 PHASE2
NCT02040597 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Chiesi Farmaceutici S.p.A.
 2014-01 PHASE1
NCT02127866 COMPLETED
Asthma
Chiesi Farmaceutici S.p.A.
 2014-04-11 PHASE2
NCT02228473 UNKNOWN
Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms
Seoul National University Hospital
 2014-09
NCT02119234 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2014-03 PHASE1
NCT02189577 COMPLETED
Chronic Obstructive Pulmonary Disease
Chiesi Farmaceutici S.p.A.
 2014-06 PHASE2
NCT02129660 COMPLETED
Hyperhidrosis
Journey Medical Corporation
 2014-04 PHASE2
NCT02430272 COMPLETED
Fever
Inje University
 2014-05
NCT02016885 COMPLETED
Hyperhidrosis
Journey Medical Corporation
 2013-11 PHASE2
NCT02410460 COMPLETED
Rhytidoplasty
Mercy Facial Plastic Surgery Center
 2013-09
NCT02038829 COMPLETED
COPD
Sunovion Respiratory Development Inc.
 2014-01 PHASE2
NCT00855283 COMPLETED
SCI
US Department of Veterans Affairs
 2012-09 PHASE2
NCT01706536 COMPLETED
COPD
Sunovion Respiratory Development Inc.
 2012-10 PHASE2
NCT01479764 COMPLETED
Surgical Procedures, Elective
Merck Sharp & Dohme LLC
 2011-12-02 PHASE3
NCT01422304 COMPLETED
Neuromuscular Blockade; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Blood Coagulation; Antithrombotic Agents
Merck Sharp & Dohme LLC
 2011-10-12 PHASE3
NCT01476813 COMPLETED
Pulmonary Disease, Chronic Obstructive
Chiesi Farmaceutici S.p.A.
 2012-03 PHASE2
NCT01453530 UNKNOWN
Anesthesia Recovery Period
Radboud University Medical Center
 2011-10 PHASE4
NCT01285492 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Novartis Pharmaceuticals
 2011-01 PHASE3
NCT01199237 COMPLETED
Airway Reflexes, Protective; Recovery After Neuromuscular Block; Anesthetic Recovery
University of California, San Francisco
 2010-08 PHASE4
NCT01120717 COMPLETED
Chronic Obstructive Pulmonary Disease
Novartis Pharmaceuticals
 2010-04 PHASE3
NCT01398111 COMPLETED
COPD
Chiesi Farmaceutici S.p.A.
 2011-05 PHASE1
NCT01191398 COMPLETED
Sialorrhea
Craig J. Huang
 2010-06
NCT01176903 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Chiesi Farmaceutici S.p.A.
 2010-08 PHASE1; PHASE2
NCT02948582 COMPLETED
Chronic Obstructive Pulmonary Disease
Sunovion Respiratory Development Inc.
 2010-07 PHASE2
NCT01176851 COMPLETED
Healthy
Chiesi Farmaceutici S.p.A.
 2010-07 PHASE1
NCT01142648 COMPLETED
Anaesthesia
Tampere University Hospital
 2009-04 PHASE4
NCT02951312 COMPLETED
Chronic Obstructive Pulmonary Disease
Sunovion Respiratory Development Inc.
 2009-05 PHASE2
NCT00315536 COMPLETED
Urological Surgery
University Hospital, Ghent
 2006-05 PHASE2
NCT00570778 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Novartis Pharmaceuticals
 2007-12 PHASE2
NCT00558285 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Novartis
 2007-11 PHASE2
NCT00491894 COMPLETED
Cerebral Palsy; Neurological Conditions; Mental Retardation; Sialorrhea
Shionogi
 2007-03 PHASE3
NCT00473694 COMPLETED
Anesthesia, General
Merck Sharp & Dohme LLC
 2005-11-28 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-04-13)

Check the Glycopyrrolate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glycopyrrolate functions as a competitive muscarinic acetylcholine receptor antagonist, blocking G-protein-coupled muscarinic receptor activation and inhibiting downstream cholinergic intracellular signaling pathways to attenuate parasympathetic tone in smooth muscle and exocrine glands. This inhibition reduces salivary and respiratory secretions while relaxing gastrointestinal smooth muscle, rendering the agent clinically effective in perioperative anesthesia management and the treatment of chronic obstructive pulmonary disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.