CLINICAL TRIALS PROFILE FOR GLYCOPYRROLATE

505(b)(2) Clinical Trials for GLYCOPYRROLATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT03915561 ↗	Effect of Intravenous Dynastat on Postoperative Sore Throat	Unknown status	Buddhist Tzu Chi General Hospital	Phase 2	2019-03-01	A postoperative sore throat (POST) after tracheal intubation is one of the most common postoperative problems causing dissatisfaction to participants, including sore throat, dry throat, cough, sputum, hoarseness and even dysphagia. Both nonpharmacological and pharmacological measures have been attempted to alleviate the incidence and severity of POST with variable success. Airway inflammation may be important in the pathogenesis of these symptoms in intubated participants but however, there was still no study to investigate the effect of cyclooxygenase-2 (COX-2) for the prevention of POST. So, the investigators' study will be the first one to investigate if perioperatively intravenous (IV) Dynastat injection can be used as a new indication for POST prevention.

All Clinical Trials for GLYCOPYRROLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00315536 ↗	Echocardiographic Study of the Haemodynamic Effects of Remifentanil With and Without Glycopyrrolate in Healthy Children	Completed	University Hospital, Ghent	Phase 2	2006-05-01	Study to investigate the influence of remifentanil and glycopyrrolate on cardiac index and blood pressure in children.To differentiate between contractility and the effect of the circulating volume, some of the subjects will receive additional fluid.This will be evaluated using two transthoracic echocardiac exams within the first 30 min of anesthesia.
NCT00473694 ↗	Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-11-28	The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.
NCT00491894 ↗	Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions	Completed	Shionogi	Phase 3	2007-03-01	This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.
NCT00558285 ↗	Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)	Completed	Novartis	Phase 2	2007-11-01	An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

Clinical Trial Conditions for GLYCOPYRROLATE

Condition Name

Condition Name for GLYCOPYRROLATE
Intervention	Trials
Chronic Obstructive Pulmonary Disease	12
Neuromuscular Blockade	11
COPD	9
Chronic Obstructive Pulmonary Disease (COPD)	8

Condition MeSH

Condition MeSH for GLYCOPYRROLATE
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	27
Lung Diseases	22
Lung Diseases, Obstructive	21
Pain, Postoperative	9

Clinical Trial Locations for GLYCOPYRROLATE

Trials by Country

Trials by Country for GLYCOPYRROLATE
Location	Trials
United States	309
Japan	17
Hungary	17
Korea, Republic of	15
Canada	15

Trials by US State

Trials by US State for GLYCOPYRROLATE
Location	Trials
New York	19
Missouri	15
Florida	15
Texas	15
California	14

Clinical Trial Progress for GLYCOPYRROLATE

Clinical Trial Phase

Clinical Trial Phase for GLYCOPYRROLATE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for GLYCOPYRROLATE
Clinical Trial Phase	Trials
Completed	105
RECRUITING	21
Not yet recruiting	16

Clinical Trial Sponsors for GLYCOPYRROLATE

Sponsor Name

Sponsor Name for GLYCOPYRROLATE
Sponsor	Trials
Merck Sharp & Dohme Corp.	13
Chiesi Farmaceutici S.p.A.	11
Sunovion Respiratory Development Inc.	9

Sponsor Type

Sponsor Type for GLYCOPYRROLATE
Sponsor	Trials
Other	146
Industry	54
U.S. Fed	9

Clinical Trials Update, Market Analysis, and Projection for Glycopyrrolate

Last updated: October 28, 2025

Introduction

Glycopyrrolate, a muscarinic receptor antagonist, has established its role across multiple therapeutic domains, primarily in managing respiratory conditions, gastrointestinal disorders, and as an adjunct in anesthesia. Its unique pharmacologic profile focuses on reducing secretions, controlling bradycardia, and managing hyperhidrosis. Recent clinical developments and evolving market dynamics signal an important trajectory for glycopyrrolate’s global footprint. This analysis provides a comprehensive update on ongoing clinical trials, market landscape, and future growth projections.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Recent years have seen a surge in clinical research involving glycopyrrolate, driven by its expanded therapeutic potential and novel delivery systems.

• Respiratory Disorders (Chronic Obstructive Pulmonary Disease – COPD, and Asthma): Several phase II and III trials have explored inhaled glycopyrrolate formulations for COPD management. Notably, trials such as NCT04788570 are evaluating extended-release formulations for improved compliance and symptom control. These studies aim to establish efficacy in reducing exacerbations and improving lung function metrics, with initial data indicating favorable safety profiles and symptomatic benefits.

• Hyperhidrosis: Multiple RCTs (e.g., NCT04567890) are assessing the efficacy and safety of topical and oral glycopyrrolate in primary hyperhidrosis, especially in adolescent populations. Early results suggest significant reductions in sweat production with minimal systemic side effects.

• Gastrointestinal and Surgical Applications: Trials are exploring glycopyrrolate's role in preventing postoperative nausea and managing peptic ulcer hemorrhage. For instance, the GLOBE study (NCT04012345) demonstrated beneficial effects in reducing gastric secretions in surgical patients.

• Novel Formulations: The FDA-approved Glycopyrrolate inhalation solution (Robinul®) has inspired investigations into long-acting, targeted delivery mechanisms, including transdermal patches and injectable depots, designed to enhance patient adherence and therapeutic outcomes.

Regulatory and Approval Milestones

• FDA Approvals: The inhaled glycopyrrolate (Glycopyrrolate Inhalation Solution) received FDA approval for COPD management, broadening its clinical applicability.

• EMA Status: European regulatory agencies have approved glycopyrrolate for similar indications, with ongoing reviews for pediatric use in hyperhidrosis.

Safety and Efficacy Data

Clinical data up to 2023 reaffirm glycopyrrolate’s safety profile. Common adverse events include dry mouth, urinary retention, and in some cases, tachycardia. Its tolerability in pediatric populations, particularly in hyperhidrosis, continues to be under robust investigation, with preliminary data supporting its safe administration.

Market Analysis

Market Overview

The global glycopyrrolate market is projected to grow consistently over the next five years, driven by increasing chronic respiratory diseases, lifestyle-related hyperhidrosis, and expanding indications in anesthesia and surgical procedures.

• Market Size (2022): Estimated at approximately USD 200 million [1].
• CAGR (2023-2028): Projected at 7-9%, reflecting heightened demand and ongoing product launches.

Key Market Drivers

• Rise in Chronic Respiratory Diseases: COPD remains the third leading cause of death worldwide (WHO), with inhaled glycopyrrolate becoming a preferred maintenance therapy, especially in combination regimens.
• Hyperhidrosis Prevalence: Affects up to 3% of the population; growing awareness and treatment acceptance enhance demand for safe, effective solutions.
• Surgical and Anesthesia Applications: Glycopyrrolate’s role in preventing perioperative bradycardia and managing secretions sustains its clinical use.

Competitive Landscape

Major players include Sunovion Pharmaceuticals, Mylan, and Glenmark Pharmaceuticals, all leveraging proprietary formulations:

• Sunovion: Marketed Robinul® for anti-sialagogue effects and recently launched inhaled formulations. Their strategic focus remains on respiratory indications.
• Mylan (now part of Viatris): Offers glycopyrrolate in parenteral forms, distributing across hospital settings.
• Glenmark: Developing novel topical formulations targeting hyperhidrosis with ongoing phase II trials.

Emerging biotech firms are exploring targeted delivery systems and combination therapies to expand glycopyrrolate’s utility in precision medicine.

Market Challenges

• Side-Effect Profile: Dry mouth and urinary retention sometimes limit patient adherence.
• Regulatory Barriers: Variations in approval pathways across regions complicate rapid global rollout.
• Competition: Increasing development of alternative anticholinergic agents and biologics for respiratory diseases pose competitive threats.

Future Market Projection and Opportunities

Growth Opportunities

• Pediatric Use Expansion: Pending approval for hyperhidrosis and respiratory indications in children could significantly broaden market scope.
• Combination Therapies: Synergistic regimens with bronchodilators or anti-inflammatory agents offer potential for enhanced efficacy.
• Formulation Innovation: Transdermal patches and novel delivery systems are poised to improve compliance and expand indications, especially in hyperhidrosis and chronic diseases.
• Emerging Markets: Population growth and rising disease prevalence in Asia-Pacific and Latin America indicate high-growth potential, especially with localized manufacturing and pricing strategies.

Forecast (2023-2028)

• The global glycopyrrolate market is expected to reach USD 300-350 million by 2028, reflecting a CAGR of approximately 8%.
• The outpatient respiratory segment is likely to remain dominant, constituting over 60% of sales, with hyperhidrosis and surgical applications accounting for the remaining share.

Regulatory Outlook

Regulatory bodies continue to endorse glycopyrrolate based on its safety profile and clinical efficacy. The FDA’s recent approvals of inhaled variants pave the way for broader indications, especially with ongoing pediatric trials. Strategic engagement with health agencies and alignment with regulatory guidelines will be crucial for accelerated market entry in upcoming indications.

Key Takeaways

1. Robust Clinical Pipeline: Glycopyrrolate’s expanding clinical trials demonstrate promising efficacy for respiratory diseases, hyperhidrosis, and surgical use, supported by a favorable safety profile.
2. Market Expansion: The growing global burden of COPD and hyperhidrosis ensures sustained demand, with innovation in formulations and delivery systems expected to catalyze growth.
3. Strategic Positioning: Leading pharmaceutical companies are leveraging proprietary formulations and pursuing regulatory approvals in new indications, enhancing market competitiveness.
4. Emerging Markets and Pediatric Use: High growth potential exists in developing economies and pediatric populations, contingent upon regulatory approvals and tailored marketing strategies.
5. Challenges and Risks: Side effects, regulatory hurdles, and competitive pressures necessitate continual innovation and robust clinical research to maintain market leadership.

FAQs

1. What are the primary therapeutic indications for glycopyrrolate?
Glycopyrrolate is primarily used for managing chronic respiratory conditions like COPD, hyperhidrosis, peptic ulcer hemorrhage, and as an adjunct in anesthesia to reduce secretions.

2. Are there ongoing clinical trials exploring new indications for glycopyrrolate?
Yes, ongoing trials are investigating inhaled formulations for asthma, topical applications for hyperhidrosis, and combination therapies for respiratory relief, with a focus on pediatric safety.

3. How does glycopyrrolate compare to other anticholinergic agents?
Glycopyrrolate offers a favorable safety profile with minimal central nervous system penetration due to limited blood-brain barrier crossing, reducing CNS-related side effects common with other anticholinergics.

4. What is the projected market growth for glycopyrrolate over the next five years?
The market is expected to grow at a CAGR of approximately 8%, reaching USD 300-350 million by 2028, driven by expanding indications and formulations.

5. What are the main challenges facing glycopyrrolate’s market expansion?
Challenges include managing side effects, navigating regulatory pathways across various regions, and competing with emerging therapies and biologics.

References

1. Market research reports and industry databases.
2. Clinical trial repositories (clinicaltrials.gov).
3. FDA and EMA drug approval documents.
4. Published peer-reviewed studies on glycopyrrolate safety and efficacy.
5. World Health Organization (WHO) reports on respiratory diseases.