CLINICAL TRIALS PROFILE FOR ATRACURIUM BESYLATE

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.

Clinical Trial Conditions for Atracurium Besylate

Condition Name

Condition Name for Atracurium Besylate
Intervention	Trials
Postoperative Pain	3
Pediatric Cancer Surgery	1
Female Breast Cancer	1
Postoperative Nausea and Vomiting	1

Condition MeSH

Condition MeSH for Atracurium Besylate
Intervention	Trials
Pain, Postoperative	2
Respiratory Distress Syndrome, Adult	1
Vomiting	1
Nose Diseases	1

Clinical Trial Locations for Atracurium Besylate

Trials by Country

Trials by Country for Atracurium Besylate
Location	Trials
Egypt	8
India	5
Thailand	1

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

Clinical Trial Status

Clinical Trial Status for Atracurium Besylate
Clinical Trial Phase	Trials
Completed	8
Not yet recruiting	3
RECRUITING	3

Clinical Trial Sponsors for Atracurium Besylate

Sponsor Name

Sponsor Name for Atracurium Besylate
Sponsor	Trials
Ain Shams University	2
Mansoura University	2
Sir Ganga Ram Hospital	2

Sponsor Type

Sponsor Type for Atracurium Besylate
Sponsor	Trials
Other	17

Atracurium Besylate Market Analysis and Financial Projection

Last updated: April 25, 2026

ATRACURIUM BESYLATE: Clinical Trials Update, Market Analysis and 5-Year Projection

What is the current clinical and regulatory footprint for atracurium besylate?

Atracurium besylate is an established, off-patent neuromuscular-blocking agent used in general anesthesia for skeletal muscle relaxation, including endotracheal intubation and maintenance of muscle relaxation during surgery. The drug’s clinical development history is mature; current activity is dominated by post-approval studies, product-specific bioequivalence work, and safety/usage investigations rather than new pivotal efficacy trials.

Key points from public clinical-trials repositories indicate that most ongoing or newly posted studies for atracurium products are:

• Cross-over or parallel bioequivalence/PK studies for generic or reformulated products.
• Observational or utilization studies assessing dosing practice, onset and recovery timing, and perioperative safety metrics.
• Special-population studies that focus on clinical workflow endpoints (time to recovery, adverse event rates) rather than novel mechanisms.

Clinical-trials refresh (public registry posture)

• Trials posted in recent years largely relate to administration practice, dosing, and safety monitoring, not new indications.
• No consistent pattern of late-stage randomized, placebo-controlled pivotal programs is evident in standard public registries for the active ingredient itself; activity tends to cluster around product competition and regional access rather than new clinical IP.

Clinical endpoint themes seen in current trial patterns (typical for NMBA product studies)

• Onset time (e.g., time to maximum block after IV administration)
• Recovery index (time to return of neuromuscular function)
• Need for rescue agents
• Incidence of adverse events (hypotension, histamine-related effects, prolonged blockade)

What dosing and formulation constraints shape development and market access?

Atracurium besylate is an IV NMBA formulated as a besylate salt. In practice, the business reality is driven by:

• Comparator generic landscape: Clinicians see multiple AB-rated generic options; differentiation occurs through PK/PD matching, labeling alignment, and supply reliability.
• Therapeutic-class substitution: Atracurium is frequently compared operationally with other NMBAs (e.g., rocuronium, vecuronium). This raises the importance of inventory stability and consistent clinical performance (onset and recovery).
• Manufacturing and regulatory continuity: Long-cycle approvals for sterile injectables and the need for batch-to-batch consistency compress the time window for entrants.

These constraints mean most incremental “clinical updates” for the market come from bioequivalence and post-market pharmacovigilance rather than new claims.

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Clinical Trials Update: What is actively changing?

Which trial types are most visible right now?

Publicly visible updates in the atracurium space skew toward the following:

1. Bioequivalence and pharmacokinetic studies

   • Goal: demonstrate exposure equivalence for generic introductions and line extensions.
   • Output: labeling alignment, substitution acceptance in hospital formularies.

2. Operational and perioperative studies

   • Goal: quantify real-world dosing patterns, onset/recovery timing, and safety signals.
   • Output: hospital protocol updates and procurement confidence.

3. Safety monitoring and protocol evaluation

   • Goal: track adverse-event rates, including events consistent with histamine release class effects.
   • Output: refinement of premedication and monitoring routines.

Clinical positioning implication: the clinical narrative for atracurium besylate stays largely stable. New trial postings do not typically create new therapeutic claims. They instead support continued market access for competing products.

What does this mean for R&D timelines?

Because the molecule is mature, R&D value shifts from discovering new clinical endpoints to:

• Meeting regulatory equivalence requirements for sterile injectables
• Ensuring manufacturing robustness to protect hospital supply contracts
• Building evidence for protocol fit (recovery profile and monitoring practicality)

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Market Analysis

How big is the atracurium besylate opportunity and what drives demand?

Atracurium besylate demand is tied to:

• Procedure volume in surgical care (elective and emergency surgeries needing intubation and muscle relaxation)
• Anesthesia practice patterns in hospitals
• Availability and price of generic versions
• Formulary decisions comparing NMBA alternatives based on onset/recovery, reversal strategy compatibility, and safety experience

Demand drivers

• High throughput of surgeries requiring general anesthesia supports baseline consumption.
• Hospitals seek predictable neuromuscular blockade management and recovery timelines.
• Competitive pricing from generics compresses unit margins but sustains volume.

Counterweights

• Formularies may shift toward alternative NMBAs when procurement favors specific procurement bundles or reversal workflows.
• Supply chain disruptions in sterile injectables can cause temporary demand swings.

Who are the demand anchors in the supply chain?

Demand concentrates around:

• Hospital and surgical center formularies
• Anesthesia service lines
• Regional purchasing organizations

Because NMBA procurement is specification-driven, the primary commercial levers are:

• Consistent supply
• Competitive WAC and contracting prices
• Label comprehension and protocol acceptance
• Pharmacovigilance record and quality reputation

Competitive intensity

The market is structurally competitive due to:

• Broad availability of generic atracurium products (typical for established sterile injectables)
• Clinically informed substitution across NMBA classes
• Ongoing competitive pressure in sterile injectable manufacturing

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5-Year Market Projection (2026-2030)

What is the projection logic for atracurium besylate sales growth?

For a mature off-patent NMBA, the typical projection structure is:

• Volume growth tracks procedure growth and broader access to surgical care.
• Value growth lags volume because of generic price competition.
• Market share shifts depend on contracting wins, supply reliability, and formulary updates.

Base case projection (directional)

Without molecule-level pricing by region and without harmonized global unit sales data for atracurium besylate specifically, a defensible projection framework uses industry-consistent assumptions for mature generics in anesthesia-related injectables:

• Moderate unit volume growth
• Low to mid single-digit value CAGR driven by a mix of procedure growth and price erosion

Projected outcome for 2026 to 2030 (base case)

• Unit volumes: low single-digit CAGR
• Market value: low to mid single-digit CAGR, with price pressure keeping the value trajectory below volume

Scenario view

• Upside: faster elective surgery normalization in major markets and contract wins for stable suppliers; improved substitution protection in anesthesia protocols.
• Downside: continued aggressive generic pricing, formulary switches to competing NMBA classes, and sporadic sterile manufacturing supply constraints.

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Commercial Implications for Investors and R&D

Where does value concentrate in atracurium besylate?

Value concentrates in:

• Manufacturing reliability for sterile injectables
• Regulatory execution (bioequivalence and labeling alignment)
• Contracting capability in hospital procurement cycles
• Quality reputation and pharmacovigilance stability

What is the most credible path to incremental advantage?

• Product-level differentiation through consistent performance data (PK/PD equivalence, reliable onset and recovery metrics)
• Supply assurance that protects formulary inclusion
• Local regulatory and reimbursement alignment for tender-based purchasing

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Key Takeaways

• Atracurium besylate is in a mature clinical phase where the visible trial activity is dominated by product-level bioequivalence, observational practice studies, and post-market safety work, not new pivotal indication trials.
• Demand is anchored to surgical volume and anesthesia practice, while economics are shaped by generic pricing and formulary substitution across NMBA classes.
• Over 2026-2030, the most defensible projection pattern is moderate unit volume growth with lower value growth due to price competition, supported by supply stability and contract wins.

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FAQs

1) Are there currently new phase 3 efficacy trials for atracurium besylate?

Public registry activity for atracurium besylate is typically dominated by non-pivotal studies (bioequivalence, PK/PD, observational safety and practice investigations), not new phase 3 efficacy programs.

2) What endpoints matter most in current atracurium studies?

Trials most often track onset and recovery-related neuromuscular function measures, time-to-recovery metrics, and adverse event patterns consistent with NMBA class monitoring.

3) Why does price pressure remain the primary market lever?

Atracurium besylate is established and off-patent in most jurisdictions, which sustains intense generic competition and tender-driven contracting.

4) What determines whether a generic atracurium product wins hospital formularies?

Supply reliability, regulatory equivalence evidence, labeling alignment with anesthesia protocols, and pharmacovigilance/quality record.

5) Does atracurium’s market outlook depend more on procedure volume or on competitive substitution?

Both, but competitive substitution and contracting drive value more directly because anesthesia teams can switch among NMBA classes based on workflow and procurement terms.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. “Atracurium besylate” and related search results (accessed 2026-04-25).
[2] U.S. Food and Drug Administration. Drug Approval Reports and labeling resources for atracurium (accessed 2026-04-25).
[3] EMA and national medicines agency product information repositories for atracurium-containing medicinal products (accessed 2026-04-25).