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Last Updated: February 9, 2025

CLINICAL TRIALS PROFILE FOR ROBINUL


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All Clinical Trials for Robinul

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT01191398 ↗ Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation Completed Craig J. Huang N/A 2010-06-01 The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
NCT02872935 ↗ Minimizing Nausea and Vomiting During Spinals for CS Terminated Kokila N Thenuwara Phase 4 2015-05-15 In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT02872935 ↗ Minimizing Nausea and Vomiting During Spinals for CS Terminated University of Iowa Phase 4 2015-05-15 In parturients undergoing Cesarean section under spinal anesthesia, co-loading of 1 liter of crystalloids, with placing the spinal, along with administering a phenylephrine infusion and glycopyrrolate, enables placing a spinal with minimal perioperative nausea and vomiting and good intra and post-operative pain relief.
NCT03513757 ↗ Dexmedetomidine and Propofol for Pediatric MRI Sedation Completed Medical College of Wisconsin Phase 4 2018-03-04 The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol). The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan. The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Robinul

Condition Name

Condition Name for Robinul
Intervention Trials
Sialorrhea 1
Spine Deformity 1
Surfactant Deficiency Syndrome Neonatal 1
Abdominal Neoplasm 1
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Condition MeSH

Condition MeSH for Robinul
Intervention Trials
Abdominal Neoplasms 1
Neurofibromatosis 1 1
Vomiting 1
Neurofibromatoses 1
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Clinical Trial Locations for Robinul

Trials by Country

Trials by Country for Robinul
Location Trials
United States 4
Canada 1
Finland 1
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Trials by US State

Trials by US State for Robinul
Location Trials
Wisconsin 1
Iowa 1
Texas 1
Pennsylvania 1
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Clinical Trial Progress for Robinul

Clinical Trial Phase

Clinical Trial Phase for Robinul
Clinical Trial Phase Trials
Phase 4 3
Phase 2 1
N/A 2
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Clinical Trial Status

Clinical Trial Status for Robinul
Clinical Trial Phase Trials
Completed 3
Unknown status 1
Recruiting 1
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Clinical Trial Sponsors for Robinul

Sponsor Name

Sponsor Name for Robinul
Sponsor Trials
University of Iowa 1
Medical College of Wisconsin 1
Oulu University Hospital 1
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Sponsor Type

Sponsor Type for Robinul
Sponsor Trials
Other 9
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Clinical Trials, Market Analysis, and Projections for Glycopyrrolate (ROBINUL)

Introduction

Glycopyrrolate, marketed under the brand name Robinul, is an anticholinergic medication widely used in various medical settings. This article will delve into the clinical trials, market analysis, and projections for glycopyrrolate, providing a comprehensive overview of its current and future landscape.

Clinical Trials and Safety Profile

Historical Clinical Trials

Glycopyrrolate has been the subject of numerous clinical trials, particularly in the context of its use in treating conditions such as chronic obstructive pulmonary disease (COPD) and for its anticholinergic properties.

  • COPD Studies: In clinical trials for COPD, glycopyrrolate has been evaluated for its efficacy and safety. For instance, the NVA237 studies involved dose-ranging trials and pivotal Phase 3 studies, which demonstrated the efficacy of glycopyrrolate at a dose of 12.5 mcg twice daily (BID) in improving lung function in patients with COPD[3].

  • Pediatric Use: Clinical trials and postmarketing data have also supported the use of glycopyrrolate in pediatric patients, particularly for treating drooling in children with cerebral palsy. These studies have shown that glycopyrrolate is effective and generally well-tolerated in this population, although with the expected anticholinergic adverse effects[4].

Safety Updates and Labeling

Recent updates to the labeling of glycopyrrolate formulations have included cautionary language for specific patient populations. For example, the combination product of neostigmine and glycopyrrolate includes warnings about the use in bradycardic patients and recommendations for anticholinergic agent use prior to neostigmine administration[1].

  • Renal Impairment: Clinical pharmacology studies have highlighted the need for caution in patients with severe renal impairment and end-stage renal disease, as systemic exposure to glycopyrrolate can be significantly higher in these patients[3].

Market Analysis

Market Size and Growth

The global glycopyrrolate market is experiencing significant growth, driven by increasing demand in various medical applications.

  • Forecast Period: The market is projected to grow at a remarkable CAGR from 2024 to 2031, with the global market size expected to expand substantially during this period[2][5].

  • Segmentation: The market is segmented by type (glycopyrrolate tablets and solutions), application (hospitals, clinics, and other settings), and geography (North America, Europe, Asia-Pacific, South America, and the Middle East & Africa). Each segment is expected to contribute to the overall growth, with hospitals and clinics being major drivers[2].

Market Dynamics

The market dynamics are influenced by several factors:

  • Drivers: Increasing prevalence of conditions such as COPD, growing demand for anticholinergic medications, and advancements in healthcare infrastructure are driving the market growth[2].

  • Restraints: Potential side effects associated with anticholinergic medications and regulatory challenges can act as restraints to the market growth[2].

  • Opportunities: Emerging markets and the development of new formulations and delivery systems present opportunities for market expansion[2].

Competitive Landscape

The glycopyrrolate market is competitive, with several key players:

  • Major Players: Companies such as Toobapharma, Infa Group, Suven Life Sciences Limited, and others are prominent in the market. These companies are focused on product innovation, strategic partnerships, and expanding their geographical presence[2].

Market Projections

Revenue Forecast

The global glycopyrrolate market is forecasted to achieve significant revenue growth by 2031. The market size is expected to increase from its current value, driven by the increasing demand for glycopyrrolate in various medical applications[2][5].

Regional Outlook

The market growth is expected to be robust across different regions:

  • North America and Europe: These regions are anticipated to remain major contributors due to advanced healthcare systems and high demand for anticholinergic medications[2].

  • Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare expenditure and a large patient population[2].

Key Takeaways

  • Clinical Trials: Glycopyrrolate has been extensively studied in clinical trials, demonstrating its efficacy and safety in various medical conditions.
  • Market Growth: The global glycopyrrolate market is projected to grow significantly from 2024 to 2031, driven by increasing demand and advancements in healthcare.
  • Segmentation: The market is segmented by type, application, and geography, with each segment contributing to the overall growth.
  • Competitive Landscape: The market is competitive, with several key players focusing on product innovation and strategic expansions.

FAQs

What are the primary uses of glycopyrrolate?

Glycopyrrolate is primarily used as an anticholinergic agent for treating conditions such as COPD, preoperative and intraoperative use, and for the treatment of peptic ulcers in adults.

What are the potential side effects of glycopyrrolate?

Glycopyrrolate can cause anticholinergic side effects such as dry mouth, constipation, and increased heart rate. It also requires caution in patients with severe renal impairment and bradycardia.

Which regions are expected to drive the growth of the glycopyrrolate market?

North America, Europe, and the Asia-Pacific region are expected to be major drivers of the glycopyrrolate market growth due to their advanced healthcare systems and large patient populations.

What is the forecasted market size of glycopyrrolate by 2031?

The global glycopyrrolate market is expected to achieve significant revenue growth by 2031, though the exact figure varies by report; it is anticipated to be in the billions of USD[2][5].

Who are the major players in the glycopyrrolate market?

Major players include Toobapharma, Infa Group, Suven Life Sciences Limited, and other companies that are involved in product innovation and strategic market approaches[2].

Sources

  1. FDA: Prevduo (Neostigmine methylsulfate and glycopyrrolate injectable) - FDA Summary Review.
  2. Market Research Intellect: Global Glycopyrrolate Market Size, Trends and Projections.
  3. FDA: NDA 207923 - Clinical Pharmacology Review.
  4. FDA: NDA 022571 - Medical Review.
  5. Market Research Reports: Glycopyrrolate - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.

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