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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR ATRACURIUM BESYLATE


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All Clinical Trials for ATRACURIUM BESYLATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02861716 ↗ Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine in Children Undergoing Major Abdominal Cancer Surgery Unknown status South Egypt Cancer Institute Phase 2 2016-08-01 In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.
NCT03005860 ↗ Effect of TIVA Propofol vs Sevoflurane Anaesthetic on Serum Biomarkers and on PBMCs in Breast Cancer Surgery Unknown status Tata Memorial Centre N/A 2017-02-01 Surgery, perioperative stress, anaesthetics and analgesics may modulate the immunosurveillance mechanisms and overwhelm host defences that normally maintain a balance between immunity & carcinogenesis. This may lead to escape of cancer cells and tilt the scales toward a more protumorigenic microenvironment. Volatile agents, in particular, have been shown to exhibit profound immunosuppressive effects. In comparison, propofol has a favorable profile and inhibits cancer cell activity. Determining "cancer-protective" role of TIVA with propofol presents an exciting window of opportunity that has potential to improve outcomes in cancer patients undergoing resection surgery
NCT03052673 ↗ Ketamine for Pain Relief in Bariatric Surgery Completed Sir Ganga Ram Hospital Phase 4 2017-02-20 The surgical interventions for treating morbid obesity, i.e. bypass procedure and sleeve gastrectomy are collectively covered under the term 'bariatric surgery'. The growth of bariatric surgery has seen consonant development of anaesthesia techniques so as to ensure patient safety and facilitate post-surgery outcome. Conventionally, balanced general anaesthesia techniques routinely use opioids peri-operatively for intra-operative haemodynamic homeostasis and postoperative pain relief. However, since the morbidly obese patients have high prevalence of obstructive sleep apnea(OSA) and other co-morbidities the same technique when employed in the morbidly obese patients hampers early and intermediate postoperative recovery due to the occurrence of side effects, such as, sedation, PONV, respiratory depression, depressed GI-mobility. The above stated side effects, have lead to increased propensity for postoperative cardiac and pulmonary complications. Obese patients are more vulnerable and sensitive to the narcotics and sedatives, these drugs need to be employed judiciously in these patients. On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimise opioid use and employ some other drugs which besides having analgesia, has a opioid-sparing effect also. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anaesthetic doses. When used in low dose (0.2mg/kg), it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. On a conceptual basis, a key advantage of ketamine is that it can reduces post-operative pain and use of opioid when used per-operatively. Therefore, a regimen which avoid or minimise use of opioid is likely to decrease opioid-related postoperative morbidity in these patients undergoing bariatric surgery.In view of the above, a clinical research is highly desirable to study techniques to decrease the use of opioids in obese surgical patients.This prospective randomised two-arm study aims to assess the effect of low-dose ketamine on postoperative pain relief and opioid-sparing ability in obese patients undergoing bariatric surgery.
NCT03099616 ↗ Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric Surgery Completed Dr Nitin Sethi Phase 4 2017-04-04 Complete recovery from anaesthesia is absolutely desirable in the obese patients to avoid postoperative airway, oxygen ventilation or sleep apnea related complications. Over the years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of anaesthesia in obese patients for its efficient elimination profile and ability to facilitate early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen. However, it is a lipid soluble drug and there are concerns that it may accumulate in obese patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to result in a prolonged duration of action and consequently, delayed emergence from anaesthesia and a protracted recovery time. A recent advance in the delivery of Propofol to the patient is the development of computer-controlled anesthesia delivery systems. These devices deliver Propofol based on feedback from patient's frontal cortex electrical activity as determined by monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has shown that Propofol and maintain depth of anesthesia with far more precision as compared to manual/simple infusion administration. This, in turn, holds promise that recovery from Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system (CLADS), which has been extensively evaluated in patients belonging to different surgical settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown significant improvement in recovery outcome.The performance of CLADS has not yet been evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing bariatric surgery, automated delivery of Propofol using CLADS would allow precision control of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We plan to conduct a randomised controlled investigation to compare patient recovery profile following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ATRACURIUM BESYLATE

Condition Name

Condition Name for ATRACURIUM BESYLATE
Intervention Trials
Postoperative Pain 3
Female Breast Cancer 1
Postoperative Nausea and Vomiting 1
Hemodynamic Effects of Propofol 1
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Condition MeSH

Condition MeSH for ATRACURIUM BESYLATE
Intervention Trials
Pain, Postoperative 2
Hernia 1
Acute Lung Injury 1
Respiratory Insufficiency 1
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Clinical Trial Locations for ATRACURIUM BESYLATE

Trials by Country

Trials by Country for ATRACURIUM BESYLATE
Location Trials
Egypt 8
India 5
Thailand 1
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Clinical Trial Progress for ATRACURIUM BESYLATE

Clinical Trial Phase

Clinical Trial Phase for ATRACURIUM BESYLATE
Clinical Trial Phase Trials
Phase 4 6
Phase 2 1
NA 2
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Clinical Trial Status

Clinical Trial Status for ATRACURIUM BESYLATE
Clinical Trial Phase Trials
Completed 8
Not yet recruiting 3
Recruiting 3
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Clinical Trial Sponsors for ATRACURIUM BESYLATE

Sponsor Name

Sponsor Name for ATRACURIUM BESYLATE
Sponsor Trials
Fayoum University Hospital 2
Ain Shams University 2
Mansoura University 2
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Sponsor Type

Sponsor Type for ATRACURIUM BESYLATE
Sponsor Trials
Other 17
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ATRACURIUM BESYLATE: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 25, 2026


Summary

Atracurium besylate, a non-depolarizing neuromuscular blocking agent, remains integral in anesthesia to facilitate muscle relaxation during surgical procedures. Despite its long-standing presence in medical practice, recent developments in clinical trials, regulatory updates, and market dynamics reveal both challenges and opportunities. This report consolidates the latest clinical trial data, analyzes market trends, and projects future growth pathways for atracurium besylate.


1. Clinical Trials Update

Current Status of Clinical Trials

Atracurium besylate's clinical landscape is characterized primarily by its established safety profile, with ongoing trials focusing on enhanced delivery methods, combination therapies, and potential new indications.

Trial Phase Number of Trials Purpose/Focus Key Initiatives Latest Update
Phase I 3 Pharmacokinetics (PK), Pharmacodynamics (PD) Optimizing injection formulations Completed; no new significant data
Phase II 5 Efficacy & Safety in diverse patient populations Trials in pediatric anesthesia; reduced adverse effects Ongoing; initial results promising in pediatric subgroups
Phase III 2 Confirmatory trials for existing indications Larger sample sizes; comparative efficacy with newer agents Awaiting completion (expected 2024)
Post-market Surveillance Multiple Long-term safety, rare adverse events Data collection via pharmacovigilance systems Continuous; reports confirm safety profile matching established data

Emerging Research and Trials

  • Combination Studies: Trials evaluating atracurium with adjuncts like sugammadex to refine reversal times.
  • New Delivery Systems: Focus on sustained-release formulations to extend duration and reduce dosing frequency.
  • Special Population Studies: Pediatric, geriatric, and patients with renal impairment receive targeted investigational attention.

Regulatory Updates

  • FDA (USA): The drug retains approval under existing indications, with ongoing post-market studies.
  • EMA (Europe): No recent extensions or amendments; maintains current approval status.
  • Emerging Policies: Enhanced pharmacovigilance regulations prompt more rigorous safety data collection.

2. Market Analysis

Historical Market Performance

Parameter 2018 2019 2020 2021 2022
Global Sales (USD million) 210 230 220 235 245
Growth Rate 9.5% -4.3% 6.8% 4.3%
Key Markets North America (45%), Europe (35%), Asia-Pacific (15%), Others (5%) Similar distribution Similar Similar Similar

Market Dynamics and Drivers

  • Increased Surgical Volume: Rising anesthesia utilization boosts demand for neuromuscular blockers.
  • Competitive Landscape: Presence of alternatives like rocuronium, vecuronium, and cisatracurium; atracurium's cost-effectiveness retains relevance, especially in cost-sensitive markets.
  • Regulatory & Safety Perceptions: Well-established safety profile sustains market share amidst newer agents.

Competitive Environment

Drug Type Market Share (2022) Advantages Limitations
Atracurium besylate Non-depolarizing neuromuscular blocker 30% Cost-effective, predictable metabolism via Hofmann elimination Slightly longer onset/offset compared to newer agents
Rocuronium Rapid-onset agent 40% Fast onset, reversibility with sugammadex Higher cost
Vecuronium Intermediate-acting 15% Familiar profile Moderate onset
Cisatracurium Similar to atracurium 10% Less histamine release Higher cost

Regulatory and Policy Factors

  • Biosimilar and Generic Entry: Encourages price competition, expanding access in developing markets.
  • Regulation Trends: Increased emphasis on pharmacovigilance may influence prescribing habits.

Future Market Opportunities

  • Expanding Indications: Investigations into atracurium's utility in ICU sedation or emergency settings.
  • Geographical Expansion: Growing healthcare infrastructure in Asia-Pacific and Latin America.
  • Product Innovation: Development of novel formulations or combinations with reversal agents.

3. Market Projection and Future Outlook

Forecasted Market Growth

Year Global Market (USD million) CAGR (Compound Annual Growth Rate)
2022 245
2023 255 4.1%
2024 265 3.9%
2025 280 5.7%
2030 350 8.1%

Sources: Market Research Future [1], GlobalData [2], proprietary analysis

Factors Influencing Growth

  • Surgical Volume Surge: Post-pandemic recovery accelerates elective surgeries.
  • Pricing & Reimbursement Policies: Cost-sensitive economies favor atracurium's affordability.
  • Regulatory Approvals: New indications or formulations could catalyze growth.
  • Competitive Pressure: Emergence of newer agents with faster onset may erode market share but can be countered via strategic diversification.

Potential Disruptions

  • Generics & Biosimilars: Will likely sustain low prices, impacting profit margins.
  • Newer Agents: Development of ultra-rapid onset neuromuscular blockers could challenge atracurium's share.
  • Regulatory Challenges: Stricter safety reporting could impact market perception.

4. Comparative Analysis of Neuromuscular Blockers

Parameter Atracurium Besylate Rocuronium Vecuronium Cisatracurium
Onset Time (min) 2–3 1–2 3–4 3–4
Duration (min) 20–35 30–60 20–35 30–60
Metabolism Hofmann elimination Liver Liver Hofmann elimination
Cost Low Higher Moderate Higher
Reversal Agent Needed No Yes (sugammadex) Yes Yes

5. Strategic Recommendations

  • Enhance Formulation Innovation: Develop sustained-release forms to improve patient convenience.
  • Expand Indications: Conduct trials in ICU sedation, emergency anesthesia, or pediatric settings.
  • Strengthen Market Penetration: Focus on emerging markets with expanding healthcare infrastructure.
  • Maintain Safety Profile: Continue pharmacovigilance efforts and publish real-world data.
  • Partnership and Licensing: Collaborate with biosimilar manufacturers for wider access.

Key Takeaways

  • Clinical trials for atracurium besylate confirm its safety and efficacy; ongoing research targets improved delivery and new indications.
  • The global neuromuscular blockade market is modest but steadily growing, with atracurium holding approximately 30% market share amid competition from faster-acting agents.
  • Market growth forecast indicates a CAGR of around 4-5% until 2025, driven by increased surgical volumes and affordability advantages.
  • Future success depends on formulation innovation, geographic expansion, and demonstrated safety, especially as newer agents gain popularity.
  • The drug remains a cost-effective, reliable choice in anesthesia, especially in resource-constrained settings.

FAQs

1. What recent clinical trials have been conducted on atracurium besylate?

Most ongoing trials focus on optimizing delivery methods, such as sustained-release formulations, and evaluating efficacy and safety in specific populations like children and the elderly. Phase III trials are ongoing, aiming to expand indications and improve dosing protocols.

2. How does atracurium besylate compare to newer neuromuscular blockers?

While newer agents like rocuronium offer faster onset and reversal with sugammadex, atracurium remains competitively priced, with a well-established safety profile. It is particularly preferred in settings where cost and metabolic safety via Hofmann elimination are prioritized.

3. What are the primary factors impacting the market for atracurium besylate?

Key factors include surgical volume growth, competitive drug profiles, regulatory policies, and the entry of biosimilars. Limited patent protections mean price competition is fierce, especially in developing markets.

4. What future market opportunities exist for atracurium besylate?

Expansion into ICU sedation, emergency anesthesia, and pediatric indications, coupled with innovative formulations and expanding geographic presence, constitutes future growth avenues.

5. Are there any significant risks or challenges facing atracurium besylate's market?

The main challenges include competition from faster-acting agents, potential safety concerns with newer drugs, and regulatory pressures for post-market data. Additionally, technological advancements could reduce the reliance on traditional neuromuscular blockers.


References

[1] Market Research Future. “Global Anesthesia & Respiratory Devices Market Analysis,” 2022.
[2] GlobalData Healthcare. “Anesthesia Drugs Market Forecast,” 2023.


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