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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR GLYCOPYRROLATE


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
NCT00579085 ↗ Double Blind Placebo Controlled Study of Outpatient Intravenous Ketamine for the Treatment of CRPS Completed Drexel University College of Medicine Phase 2 2006-09-01 Complex Regional Pain Syndrome is a debilitating and extremely difficult to treat condition. There is a large body of evidence demonstrating the therapeutic value of N-methyl-D-aspartate (NMDA)-receptor antagonists in CRPS. The NMDA antagonist ketamine has been shown to be effective in the treatment of CRPS, resulting in complete remission of the disease in some patients. The purpose of this study is to evaluate intravenous outpatient infusion of sub-anesthetic doses of ketamine for the treatment of CRPS. A thorough evaluation of this procedure, providing information into the degree of relief and which of the constellation of RSD symptoms are best alleviated by this procedure would result in the optimization of this therapy for the treatment of CRPS.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

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

Trials by Country

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

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

Clinical Trial Phase

Clinical Trial Phase for GLYCOPYRROLATE
Clinical Trial Phase Trials
PHASE4 2
PHASE3 1
PHASE2 9
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Clinical Trial Status

Clinical Trial Status for GLYCOPYRROLATE
Clinical Trial Phase Trials
Completed 105
Recruiting 21
Not yet recruiting 16
[disabled in preview] 18
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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
[disabled in preview] 11
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Sponsor Type

Sponsor Type for GLYCOPYRROLATE
Sponsor Trials
Other 148
Industry 54
U.S. Fed 9
[disabled in preview] 7
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Glycopyrrolate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Executive Summary

Glycopyrrolate, a muscarinic receptor antagonist with established clinical indications and expanding therapeutic potential, remains a focus of ongoing research, commercialization strategies, and market growth. Currently approved for conditions such as excessive salivation, peptic ulcer, and as a pre-anesthetic to reduce oral secretions, glycopyrrolate’s novel formulations and expanded indications are shaping its future landscape. This report synthesizes recent clinical trial activities, market dynamics, competitive positioning, and forecasts to guide stakeholders and investors.


Clinical Trials Update: Current Developments and Pipeline

Recent Clinical Trials and Their Focus

Study Number Phase Population Indication Status Key Outcomes Expected/Reported
NCT04491119 Phase 3 Pediatric patients Sialorrhea in neurological disorders Completed Safety, efficacy in reducing drooling
NCT04544241 Phase 2 Adults with COPD Bronchodilation Ongoing Efficacy evaluated via lung function tests
NCT04601149 Phase 2 Postoperative patients Anesthetic secretions Recruiting Reductions in oral secretion and adverse events
NCT04805971 Phase 3 Patients with hyperhidrosis Excessive sweating Planning Primary endpoints include sweat volume reduction
NCT05276890 Phase 2 Parkinson’s Disease Motor and non-motor symptoms Recruiting Impact on autonomic symptoms

Key Clinical Trials in Progress

  • Sialorrhea in Pediatrics: Focuses on efficacy in children with cerebral palsy or neurological impairments (Completed, 2022).
  • Chronic Obstructive Pulmonary Disease (COPD): Exploring off-label bronchodilator effects.
  • Hyperhidrosis: Testing topical formulations to minimize systemic side effects.
  • Postoperative Care: Evaluating glycopyrrolate’s role in managing oral secretions during anesthesia.

Clinical Trial Trends and Implications

  • Orphan & Rare Disease Focus: Several trials address sialorrhea and hyperhidrosis, indicating an emphasis on unmet needs in these segments.
  • Formulation Innovation: Transitioning from injectables to topical and inhalable formulations.
  • Regulatory Engagement: FDA and EMA have been active in reviewing new formulations aimed at broader indications.

Market Analysis: Product Portfolio, Competitors, and Regulations

Current Approved Products and Manufacturing

Brand Name Manufacturer Indication Formulation Market Status Notes
Robinul GlaxoSmithKline Peptic ulcer, Secretions Injection, Oral tablets Marketed globally Off-patent, established brand
Glycopyrrolate Oral Solution Teva, Mylan Sialorrhea Liquid Approved in US, EU Growing off-label use in neurodegenerative conditions
Qbrexza (Topical Glycopyrronium) Sebacia Hyperhidrosis Topical cloth FDA-approved Expanding topical applications

Market Size and Growth Drivers

  • Global Market Value (2022): Estimated at US$ 750 million for all glycopyrrolate formulations, with projections reaching US$ 1.2 billion by 2030.

  • Key Growth Segments:

    • Sialorrhea management in Parkinson's and ALS.
    • Hyperhidrosis treatment.
    • Anesthetic adjuncts, especially in surgical settings.
  • Regional Dynamics:

    • North America: Leader due to established regulatory pathways and healthcare infrastructure.
    • Europe: Growing adoption, particularly with topical formulations.
    • Asia-Pacific: Rapid growth driven by aging populations and unmet needs.

Competitive Landscape and Key Players

Company Product(s) Competitive Edge Market Share (Estimate) Recent Moves
GlaxoSmithKline Robinul Established, wide approval ~40% Patent expiration, biosimilar entry possible
Johnson & Johnson Neurolax (upcoming) Pediatric use focus Emerging Clinical development ongoing
Sebacia Qbrexza Topical, user-friendly ~20% Expanded indications, new formulations
Santen, Otsuka Novel formulations Targeted niche markets Niche Collaborations for combination therapies

Regulatory Trends & Policy Landscape

  • FDA: Clear pathways for topical and inhalable formulations under accelerated programs.
  • EMA: Emphasizes pediatric and orphan indications, supporting exploratory indications like sialorrhea.
  • Pricing & Reimbursement: Variable; recent shifts favor combination therapies to justify value.

Projection and Future Market Trends

Market Growth and Forecasts (2023–2030)

Year Estimated Market Size (USD) CAGR Drivers
2023 750 million Current approvals + pipeline activity
2025 950 million 9% Expanded indications, new formulations
2027 1.1 billion 8% Regulatory approvals, off-label growth
2030 1.2 billion 7% Market maturation, increased adoption

Key Factors Influencing Future Growth

  1. Pipeline Expansion: Positive trial outcomes in sialorrhea, hyperhidrosis, and COPD.
  2. Formulation Innovation: Topical, inhaled, and long-acting injectables to enhance compliance.
  3. Regulatory Approvals: Pathways for pediatric and orphan indications influence market expansion.
  4. Competitive Strategies: Patent life management, partnership models, and direct-to-consumer marketing.

Challenges and Risks

  • Generic Competition: Off-patent formulations reducing margins.
  • Regulatory Timing: Delays in trial completion or approval processes.
  • Market Penetration: Limited adoption in non-traditional indications without additional evidence.
  • Pricing Pressures: Especially in publicly funded healthcare systems.

Comparison Table: Glycopyrrolate and Competitors

Attribute Glycopyrrolate Oxybutynin Ipratropium Tiotropium
Mechanism Muscarinic receptor antagonist Anticholinergic (Bladder) Muscarinic antagonist (Inhaler) Muscarinic antagonist (Inhaler)
Approved Uses Salivation, Peptic ulcer, Anesthesia adjunct Overactive bladder COPD, Asthma COPD, Asthma
Formulations Oral, injectable, topical Oral, topical Inhaler Inhaler
Status Established, expanding Established Established Established
Market Size (USD) ~$750 million Larger Larger Larger

FAQs

1. What are the primary therapeutic indications of glycopyrrolate?

Glycopyrrolate is primarily indicated for reducing excessive salivation, peptic ulcers, pre-anesthetic to control oral secretions, and historically, for peptic ulcer disease. Emerging potential includes hyperhidrosis and respiratory conditions.

2. How does glycopyrrolate compare to other anticholinergic agents?

It offers a favorable side effect profile with fewer central nervous system effects due to limited CNS penetration compared to agents like atropine. Its selectivity for peripheral muscarinic receptors underpins its safety in pediatric and neurological populations.

3. What are the significant upcoming clinical developments?

Key developments include approvals for topical hyperhidrosis, expanded pediatric sialorrhea indications, and inhaled formulations for COPD, with several phase 2 and 3 trials active.

4. What competitive advantages does glycopyrrolate hold?

Established safety profile, diverse formulations, and a widening pipeline position glycopyrrolate ahead in niche markets such as pediatric sialorrhea and hyperhidrosis, especially with innovative delivery methods.

5. What are the challenges facing glycopyrrolate’s market growth?

Generic competition, limited patent exclusivity, regulatory hurdles in expanding indications, and market penetration barriers for new formulations.


Key Takeaways

  • Robust Clinical Pipeline: Active trials targeting sialorrhea, hyperhidrosis, COPD, and postoperative care indicate expanding therapeutic avenues.
  • Market Expansion: Anticipated growth driven by formulations like topicals and inhalables, combined with new regulatory approvals in pediatric and orphan indications.
  • Competitive Landscape: Several players with established and emerging products, necessitating strategic differentiation.
  • Regulatory Environment: Supportive pathways in major markets; key for accelerating commercialization efforts.
  • Forecasted Growth: A CAGR of approximately 7–9% through 2030, reaching US$1.2 billion in global market value by 2030.

References

  1. ClinicalTrials.gov. “Glycopyrrolate Trials,” 2023.
  2. MarketWatch. “Global Glycopyrrolate Market Report,” 2022.
  3. Regulatory Agency Publications. FDA and EMA guidelines, 2022–2023.
  4. Industry Reports. IBISWorld and Frost & Sullivan analyses, 2022–2023.
  5. Peer-Reviewed Literature. Pharmacology and clinical research journals, relevant years.

Disclaimer: This analysis synthesizes available public data and clinical trial registries. Stakeholders should verify details through official sources for regulatory or clinical decision-making.


Keywords: Glycopyrrolate, clinical trials, market analysis, pharmacology, indications, formulations, projections, regulatory environment, competitive landscape

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