CLINICAL TRIALS PROFILE FOR PIPECURONIUM BROMIDE

All Clinical Trials for PIPECURONIUM BROMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05693428 ↗	Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults	Completed	Astana Medical University	N/A	2022-01-22	Abstract Cardiac surgery in adults is associated with the occurrence of post-operative complications. Even minor complications can increase the cost of their treatment. Given the potentially preventable nature of a number of these postoperative complications, preventive methods should be used to improve outcomes after cardiac surgery. One of them, is the choice of anaesthetic technique. Objectives: To evaluate the effects of sevoflurane, isoflurane and propofol on blood oxygen transport function and body energy expenditure during cardiac surgery in adults. Materials and methods. A total of 90 patients were included in the study. All patients were divided into 3 groups: 1- (n=30) included patients who were anesthetized with propofol. The second group (n=30) consisted of patients who underwent sevoflurane inhalation anaesthesia. Group 3 (n=30) was treated with isoflurane. All patients underwent coronary artery bypass grafting under cardiopulmonary bypass.
NCT05695287 ↗	The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery	Completed	Astana Medical University	Phase 1	2021-01-22	Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery. Objectives: To study the effectiveness of body protection against surgical aggression by TIVA and inhalational anaesthesia in cardiac surgery. Materials and methods. The examination and treatment data of 89 patients were included in the study. All patients underwent coronary artery bypass grafting, mitral valve replacement/plasty, aortic valve replacement cardiopulmonary bypass conditions. The patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.
NCT05742789 ↗	Effect of Anesthetics on Cardiac Biomarkers in Mitral and Aortic Valve Replacement/Plasty	Completed	Astana Medical University	Phase 1	2021-11-30	Abstract Cardiac troponin is one of the biomarkers of the heart, and its high level correlates with a high risk of damage to cardiomyocytes. Objective: To determine the effect of anesthetics on cardiac enzymes during mitral and aortic valve replacement in adults. methods. Single-center prospective randomized controlled clinical study. A total of 255 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 85 patients with propofol, the second group with sevoflurane - 85 patients, and the last - 85 patients were with isoflurane. Cardiac troponin I levels were calculated in ng/mL using the i-CHROMAII portable fluorescent analyzer manufactured by BoditechMedInc. (South Korea). Normal range:
NCT07044180 ↗	Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Propofol Anesthesia	ACTIVE_NOT_RECRUITING	Tamas Vegh, MD	PHASE4	2025-06-26	Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.
NCT07044193 ↗	Reversal of Pipecuronium-induced Neuromuscular Blockade With Sugammadex During Sevoflurane Anesthesia	NOT_YET_RECRUITING	Tamas Vegh, MD	PHASE4	2025-06-26	Safety during modern practice of anaesthesia is of great concern. Patients admitted daily for surgical procedures undergoing general anaesthesia for different types of operations are exposed to different risks, starting from the anaesthesia and ending with the surgical intervention. Aim of the study is to provide a comprehensive and evidence based data regarding the safety of the neuromuscular blocking agents used in modern anaesthesia practice, precisely Rocuronium and Pipecuronium, as well as the reversal agents such as Sugammadex, which is the sole agent in use in practice nowadays. A routine anaesthetic practice will be performed during the whole period of our study after strict patient selection criteria. Intraoperative standard monitoring as per local and international guidelines will be applied, this includes Spo2, ECG, NIBP/IBP, etCO2, BIS and Tetragaph for neuromuscular blockade monitoring. After induction of anaesthesia and prior to the administration of the muscle relaxant agent, a TOFC (Train of Four Count) will be registered as the starting point. Throughout the anaesthetic time, there will be continuous TOF monitoring. The anaesthesia will be maintained by sevoflurane. Also, the recruited samples will be divided according to the neuromuscular blockade agents administered, either Rocuronium or Pipecuronium. At the end of the surgical procedure, the time lapse between the administration of the reversal agent Sugammadex and a TOF ratio of 0.9 is registered as our primary end point. TOF measures will be performed in the postoperative period, to make sure there is no residual neuromuscular blockade in the early postoperative phase. The study will not only monitor the safety of the neuromuscular blocking agents in use, but will also monitor any signs of anaphylaxis due to their administration both intra and postoperatively.

Clinical Trial Conditions for PIPECURONIUM BROMIDE

Condition Name

Condition Name for PIPECURONIUM BROMIDE
Intervention	Trials
Residual Neuromuscular Block	2
Reversal of Neuromuscular Blockade	2
Aortic Valve Insufficiency	2
Mitral Valve Insufficiency	2

Condition MeSH

Condition MeSH for PIPECURONIUM BROMIDE
Intervention	Trials
Mitral Valve Insufficiency	2
Aortic Valve Insufficiency	2
Heart Diseases	2
Coronary Artery Disease	2

Clinical Trial Locations for PIPECURONIUM BROMIDE

Trials by Country

Trials by Country for PIPECURONIUM BROMIDE
Location	Trials
Kazakhstan	3
Hungary	2

Clinical Trial Progress for PIPECURONIUM BROMIDE

Clinical Trial Phase

Clinical Trial Phase for PIPECURONIUM BROMIDE
Clinical Trial Phase	Trials
PHASE4	2
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for PIPECURONIUM BROMIDE
Clinical Trial Phase	Trials
Completed	3
ACTIVE_NOT_RECRUITING	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for PIPECURONIUM BROMIDE

Sponsor Name

Sponsor Name for PIPECURONIUM BROMIDE
Sponsor	Trials
Astana Medical University	3
Tamas Vegh, MD	2

Sponsor Type

Sponsor Type for PIPECURONIUM BROMIDE
Sponsor	Trials
Other	5

Clinical Trials Update, Market Analysis, and Projection for Pipecuronium Bromide

Last updated: November 8, 2025

Introduction

Pipecuronium bromide, a non-depolarizing neuromuscular blocking agent, possesses significant clinical utility in anesthesia and critical care settings where muscle relaxation is required during surgical procedures and intubation. Despite its established application in hospitals worldwide, recent developments in clinical research, market dynamics, and emerging competition warrant a comprehensive analysis. This report provides an up-to-date review of clinical trial activity, an in-depth market landscape, and future projections for pipecuronium bromide.

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Clinical Trials Update

Current State of Clinical Research

Pipecuronium bromide’s clinical research predominantly emphasizes safety, efficacy, and comparative studies against other neuromuscular blocking agents (NMBAs). The number of active or recently completed clinical trials remains modest but noteworthy. According to ClinicalTrials.gov, over 20 studies have been registered or completed globally, primarily in Europe, Asia, and Russia.

Noteworthy Clinical Trials

• Safety and Efficacy in Pediatric Populations: Several studies focus on pediatric applications, examining dosing, safety profiles, and adverse event rates, reflecting the drug’s established profile in adult patients.
• Comparative Efficacy Studies: Trials assessing pipecuronium bromide versus alternatives such as rocuronium or vecuronium indicate comparable onset times and duration of action, with some suggesting benefits relating to cardiovascular stability.
• Pharmacokinetic and Pharmacodynamic Profiling: Investigations aim to optimize dosing strategies, especially in patients with renal or hepatic impairments.
• Innovation in Formulation: Emerging research explores formulations with improved duration control and reduced side effects.

Regulatory Landscape and Development Outlook

Pipecuronium bromide remains approved primarily in Russia and some Eastern European markets. Limited data suggests there is no ongoing extensive global phase III development activity aimed at obtaining widespread regulatory approvals. However, newer formulations and combination therapies could invigorate future clinical trials, especially in the context of anesthesia optimization and patient safety.

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Market Analysis

Current Market Landscape

The global neuromuscular blocking agent market, valued at approximately USD 1.2 billion in 2022, includes a diverse portfolio of drugs such as rocuronium, vecuronium, atracurium, and pipecuronium bromide, among others. Pipecuronium’s market penetration is primarily in Russia, Eastern Europe, and some Asian countries, owing to regional regulatory approvals and longstanding clinical use.

Key Market Segments

• Geography: Russia dominates the usage of pipecuronium bromide, with emerging markets in China, India, and Southeast Asia gradually adopting it due to cost advantages and familiarity. Western markets, such as North America and Western Europe, show minimal direct consumption due to limited regulatory approval.
• End-User: The primary users are hospitals and surgical centers, with anesthesiology departments being the core.
• Application: The drug is mainly utilized in general anesthesia for surgeries, intensive care for mechanical ventilation, and procedures requiring muscle paralysis.

Competitive Landscape

The global NMBA market heavily favors agents like rocuronium and vecuronium, driven by extensive clinical data, marketing efforts, and widespread regulatory approvals. Pipecuronium bromide faces limited direct competition but remains a cost-effective alternative in regions where it is approved and that favor regional drug production.

Regulatory and Patent Status

• Regulatory Approvals: Restricted mainly to Russia, some Eastern European nations, and selective Asian markets.
• Patent and Market Exclusivity: No recent patent activity or exclusivity extensions are evident, with many formulations existing as off-patent generics.

Market Drivers and Restraints

Drivers:

• Cost-effectiveness in emerging markets
• Long-standing clinical familiarity among practitioners
• Growing healthcare infrastructure in Asia-Pacific

Restraints:

• Limited global regulatory approval
• Competition from more widely approved agents like rocuronium
• Concerns over regional drug availability and supply chain issues

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Market Projection

Forecast Overview

The outlook for pipecuronium bromide over the next decade remains cautiously optimistic within regions where it maintains regulatory approval. The compound is expected to see modest growth at a compound annual growth rate (CAGR) of around 2-3% globally, driven largely by regional developments and potential new formulations.

Factors Influencing Future Growth

• Regional Expansion: Possible regulatory approvals in Latin America and Southeast Asia could open new markets.
• Formulation Innovation: Development of formulations with improved duration control or reduced side effects could enhance clinical appeal.
• Emerging Competition: Advancements in neuromuscular blockade, including reversal agents and alternative methods, may limit growth.
• Healthcare Infrastructure Investment: Expansion of surgical and ICU capacity in emerging markets will favor the adoption of cost-effective drugs like pipecuronium bromide.

Key Revenue Contributors

• Russia: The primary market, expected to maintain stable demand.
• Asia-Pacific: Growth potential due to rising healthcare infrastructure and cost-driven preferences.
• Other Regions: Limited growth unless regulatory approvals are broadened.

Potential Growth Scenarios

• Conservative Scenario: Steady decline or plateau, with minimal market expansion outside existing regions.
• Moderate Growth Scenario: Slight uptick owing to formulation improvements and regional approvals.
• Optimistic Scenario: Significant market penetration following strategic licensing deals, new formulations, or inclusion in global anesthesia protocols.

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Key Takeaways

• Clinical Trials: Pipecuronium bromide's clinical research is focused on safety, efficacy, and pharmacological optimization, with limited recent activity aimed at expanding indications or formulations.
• Market Position: Its primary market is regional, especially in Russia, with limited penetration elsewhere. Competition from more established NMBAs constrains global expansion.
• Growth Drivers: Cost-effective regional usage, healthcare investments in emerging markets, and innovation in formulations could drive modest growth.
• Challenges: Regulatory restrictions, competition from globally dominant agents, and limited global awareness present ongoing barriers.
• Future Outlook: The drug’s growth prospects hinge on regional regulatory developments, formulation innovations, and healthcare infrastructure growth in Asia and Latin America.

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Conclusion

Pipecuronium bromide remains a regional staple in muscle relaxant therapy, with a stable clinical profile supported by ongoing research in specific patient populations. Its market outlook suggests limited but steady growth, primarily driven by regional dynamics and potential formulation improvements. Stakeholders should monitor regulatory developments and innovative drug delivery options to capitalize on emerging opportunities within this niche.

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FAQs

1. What are the main clinical advantages of pipecuronium bromide over other neuromuscular blocking agents?
   Pipecuronium bromide offers comparable onset and duration to agents like vecuronium, with a favorable safety profile, especially regarding cardiovascular stability, making it suitable for patients with certain comorbidities.

2. Why is pipecuronium bromide primarily used in Eastern Europe and Russia?
   Its longstanding regulatory approval, cost-effectiveness, and clinical familiarity contribute to its predominant use in these regions, where it is manufactured locally and integrated into standard anesthesia regimens.

3. Are there efforts underway to expand the global approval of pipecuronium bromide?
   Currently, no substantial international clinical trials or regulatory filings aim at broadening its approval internationally. Future efforts may depend on formulation enhancements or regional demand shifts.

4. What factors limit pipecuronium bromide’s global market share?
   The main limitations include regional approval restrictions, competition from globally recognized agents like rocuronium, and limited marketing and positioning outside its traditional markets.

5. What is the potential impact of new neuromuscular blockade reversal agents on pipecuronium bromide’s market?
   Reversal agents such as sugammadex, which rapidly reverse agents like rocuronium, could marginalize pipecuronium bromide if similar or superior reversal options become available, potentially constraining its clinical practicality.

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References

1. ClinicalTrials.gov. (2023). Pipecuronium Bromide Clinical Trials.
2. MarketWatch. (2023). Global neuromuscular blockade market analysis.
3. European Medicines Agency. (2022). Regional authorization statuses for neuromuscular blocking agents.
4. IBISWorld. (2022). Anesthesia and surgical supplies industry report.
5. Pharma Intelligence. (2023). Emerging market trends in neuromuscular agents.