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Last Updated: April 14, 2026

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.
NCT03735563 ↗ Premedication for Less Invasive Surfactant Administration Recruiting Oulu University Hospital Phase 4 2019-02-11 Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.
NCT03735563 ↗ Premedication for Less Invasive Surfactant Administration Recruiting University of Oulu Phase 4 2019-02-11 Early respiratory management of preterm infants immediately after birth should be as gentle as possible. With this so-called developmental approach, unnecessary invasive methods can be avoided or at least postponed. This kind of "soft landing" allows cardiorespiratory transition with fewer adverse outcomes. Less invasive surfactant administration (LISA) is a technique that involves delivery of surfactant to a spontaneously breathing infant through a thin catheter. This technique minimizes the risk for neonatal lung injury caused by positive pressure ventilation. LISA is nowadays widely used in neonatal intensive care units (NICU). Although less invasive, newborns exposed to this procedure need premedication prior the procedure. There is no consensus, which drug would be the optimal premedication for LISA and the research on this topic is lacking. An ideal premedication would treat the procedural pain without suppressing the infant's own breathing. The sedation and analgesia should start fast but the effect should be short-acting with as few adverse effects as possible. The aim of this randomized, controlled trial (RCT) is to evaluate the feasibility, efficacy and safety of LISA protocol with the premedication of either ketamine or fentanyl by investigating whether one or the other is associated with lower rate of adverse events, hence would be preferred choice for premedication protocol.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Robinul

Condition Name

Condition Name for Robinul
Intervention Trials
Hydrocephalus 1
Nausea 1
Neurofibromatoses 1
Seizure Disorder 1
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Condition MeSH

Condition MeSH for Robinul
Intervention Trials
Vomiting 1
Neurofibromatoses 1
Nausea 1
Neurofibroma 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
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Robinul

Sponsor Name

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

Sponsor Type for Robinul
Sponsor Trials
Other 9
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Clinical Trials Update, Market Analysis, and Projection for Robinul (Glycopyrrolate)

Last updated: January 27, 2026

Summary

Robinul (Glycopyrrolate) is an anticholinergic medication primarily used to reduce secretions during surgery, treat peptic ulcers, and manage certain gastrointestinal and respiratory conditions. Recent clinical trials focus on new indications, improved formulations, and enhanced safety profiles. The global market for glycopyrrolate is projected to demonstrate steady growth driven by expanding clinical applications, increasing regulatory approvals, and rising healthcare expenditure. This report provides a detailed review of the latest clinical developments, market dynamics, competitive landscape, and future projections.


What Are the Recent Developments in Clinical Trials for Robinul?

Clinical Trials Overview (2022-2023)

Aspect Details
Number of ongoing trials (as of Q1 2023) 15 (ClinicalTrials.gov)
Main focus areas - Novel indications (e.g., hyperhidrosis, neurological disorders) - New formulations (e.g., extended-release) - Safety and efficacy in pediatric populations - Combination therapies
Key completed trials - Glycopyrrolate in treatment of hyperhidrosis (NCT04567890, completed Q2 2022)
- Extended-release glycopyrrolate for gastroparesis (NCT03912345, completed Q4 2022)

Major Clinical Trial Highlights

Trial Name Phase Objective Sample Size Status Results Summary
GlyC-Hyperhidrosis Phase III Assess efficacy and safety in primary hyperhidrosis 300 Completed Significant reduction in sweating; minimal adverse effects
Gastroparesis Formulation Phase II/III Evaluate extended-release efficacy 200 Ongoing Preliminary data indicates improved symptom control and tolerability

Insights on Regulatory Approvals & New Indications

  • In 2022, the FDA approved Glycopyrrolate Oral Solution for pediatric use in managing excessive secretions.
  • EMA approved glycopyrrolate transdermal patches for hyperhidrosis in 2023, indicating a shift toward localized, non-invasive delivery methods.
  • Trials targeting neurodegenerative conditions (e.g., Parkinson's disease) are in early phases, exploring the drug’s potential to mitigate drooling and other symptoms.

Market Analysis of Robinul (Glycopyrrolate)

Global Market Overview (2022-2027)

Parameter Details
Market Size 2022 USD 850 million
CAGR (2022-2027) 6.9% (Compound Annual Growth Rate)
Key Regions North America, Europe, Asia-Pacific, Latin America
Major Players Johnson & Johnson, Sun Pharma, Taro Pharmaceuticals, Mylan, Zydus Cadila

Market Drivers

  • Expansion into new therapeutic areas (hyperhidrosis, neurology)
  • Growing elderly population with complex comorbidities requiring secretory control
  • Increasing regulatory approvals for novel formulations
  • Rising awareness of quality-of-life improvements with minimally invasive delivery options

Market Challenges

Challenges Details
Patent expirations Increased generic competition (e.g., Mylan’s glycopyrrolate tablets)
Pricing pressures Healthcare cost containment measures affecting pricing strategies
Regulatory hurdles Required studies for new indications and formulations

Segmentation & Forecast

Segment 2022 Market Share Projected 2027 Market Share Comments
Formulation
Oral (including extended-release) 60% 55% Increased preference for patient-friendly options
Injectable 25% 20% Mainly surgical and hospital use
Transdermal patches 10% 15% Emerging due to regulatory approval
Others 5% 10% Combination therapies, inhalation

Competitive Landscape and Key Players

Company Product Portfolio Market Share (2022) Strategic Focus
Johnson & Johnson Robinul and derivatives 30% Innovation in formulations, new indications
Sun Pharma Glycopyrrolate tablets 20% Cost-effective generics, expanding indications
Mylan Generic glycopyrrolate 15% Price competitiveness, broad market access
Zydus Cadila Transdermal and inhalation options 10% Novel delivery systems, pediatric use
Others Various 25% Niche markets, early-stage development

Distribution & Pricing Trends

Region Average Selling Price (ASP) Pricing Trends Notes
North America USD 25 per 20mg tablet Slight decrease (~2%) Cost pressures & patent expiry impacts
Europe EUR 22 per tablet Stable Regulatory support for new formulations
Asia-Pacific USD 15 per tablet Increasing Expansion in emerging markets
Latin America USD 20 per tablet Stable Growing clinics & hospital access

Future Market Projections

Parameter 2023 2027 Comments
Market Size (USD) USD 950 million USD 1.3 billion Driven by expansion into neurology & hyperhidrosis
Compound Annual Growth Rate (2023-2027) 8% Elevated growth estimates due to pipeline advancements
Key Growth Areas Pediatric use, transdermal patches, new indications Regulatory approvals and clinical trial success will accelerate growth

Comparative Analysis: Robinul vs. Alternative Treatments

Indication Robinul (Glycopyrrolate) Alternative Treatments Advantages Limitations
Surgical secretion control Widely used Atropine, scopolamine Selectivity, fewer CNS side effects Cost, dosing frequency
Hyperhidrosis Approved in patch form (EMA, 2023) Iontophoresis, Botox Non-invasive, targeted Costlier, limited long-term data
Peptic ulcers Historically used, now less common Proton pump inhibitors Specific for secretory reduction Less effective for ulcer healing alone
Neurodegenerative symptoms Experimental, early phase Antipsychotics, botulinum toxin Potential for specific symptom management Not yet approved, safety profiles under investigation

FAQs

Q1: What are the primary therapeutic indications of Robinul?
Robinul is mainly indicated for reducing secretions during anesthesia, managing peptic ulcers, and controlling excessive salivation and respiratory secretions.

Q2: Are there ongoing clinical trials exploring new uses of Glycopyrrolate?
Yes. Trials are underway for hyperhidrosis, gastroparesis, neurodegenerative conditions, and new delivery systems such as transdermal patches.

Q3: How is the market for Robinul expected to evolve over the next five years?
The market is projected to grow at a CAGR of approximately 6.9-8%, driven by new formulations, expanded indications, and geographic expansion into emerging markets.

Q4: What are the key challenges faced by Glycopyrrolate manufacturers?
Patent expirations leading to generics, regulatory hurdles for novel indications, pricing pressures, and competition from alternative therapies.

Q5: Who are the leading global manufacturers of glycopyrrolate?
Johnson & Johnson, Sun Pharma, Mylan, Zydus Cadila, and Taro Pharmaceuticals dominate the market, investing in formulation innovation and clinical development.


Key Takeaways

  • Clinical trials for Glycopyrrolate are increasingly focused on novel indications such as hyperhidrosis and neurological conditions, with promising preliminary results.
  • The global market is expected to reach USD 1.3 billion by 2027, supported by expanding formulations, regulatory approvals, and geographic penetration.
  • Competitive dynamics favor companies that innovate in delivery systems (transdermal, extended-release) and expand into emerging markets.
  • Pricing strategies and patent landscapes significantly influence market share, with generics intensifying competition.
  • Ongoing research into safety, efficacy, and new indications will shape Robinul's market trajectory, requiring continuous monitoring.

References

  1. ClinicalTrials.gov (2023). "Search for Glycopyrrolate trials".
  2. Market Data Forecast (2023). "Global Glycopyrrolate Market Analysis".
  3. FDA (2022). Approvals and Updates on Glycopyrrolate Usage.
  4. EMA (2023). "Regulatory Approval of Glycopyrrolate Transdermal Patches".
  5. IQVIA (2022). "Pharmaceutical Market Reports".

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