CLINICAL TRIALS PROFILE FOR MIVACRON

All Clinical Trials for MIVACRON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01906528 ↗	Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium	Completed	Oslo University Hospital	Phase 1	2013-03-01	Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous studies have shown that males and females respond differently to this kind of drug. Our hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant) than females, meaning that males need a lower blood concentration of the drug than females in order to obtain a given effect.
NCT01906528 ↗	Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium	Completed	University of California, San Francisco	Phase 1	2013-03-01	Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous studies have shown that males and females respond differently to this kind of drug. Our hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant) than females, meaning that males need a lower blood concentration of the drug than females in order to obtain a given effect.
NCT02117401 ↗	A Prospective, Multi-center, Randomized Controlled Study of Muscle Relaxation Effect and Safety of Mivacurium Chloride in Pediatric Surgery Patients	Completed	Jiangsu Nhwa Pharmaceutical Co., Ltd.	Phase 4	2012-01-01	To evaluate the effect and safety of mivacurium chloride in pediatric patients.
NCT02473601 ↗	Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis	Unknown status	Jiangsu Nhwa Pharmaceutical Co., Ltd.	Phase 2	2014-10-01	Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed recovery phenomenon
NCT02473601 ↗	Mivacurium Chloramine Muscle Relaxation Effect in Patients With Liver Cirrhosis	Unknown status	Tang-Du Hospital	Phase 2	2014-10-01	Observed the muscle relaxation of mivacurium in patients with liver cirrhosis.Clear of mivacurium in patients with liver cirrhosis without muscle relaxant accumulation and delayed recovery phenomenon
NCT02664142 ↗	BIS Monitoring of the Depth of Anaesthesia in Children	Completed	University Hospital Ostrava	N/A	2015-06-01	General anaesthesia (GA) is, according to many definitions, the greatest gift presented to the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it is necessary to observe the clinical condition of the patient, and at the same time monitor the patient's overall condition. With the currently available options of GA management (e.g. use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in combination with various methods of topical anaesthesia) the importance of methods measuring the depth of GA increases. The depth of GA may be defined as a continuous progressive decreasing of the central nervous system, together with a decreased reactivity to stimuli. In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during a surgical procedure may result in significant psychological complications (e.g. post-traumatic stress disorder), and the patient may suffer from a serious long-time disorder.
NCT03019835 ↗	Can we Antagonize Mivacurium With Neostigmine ?	Completed	Université Libre de Bruxelles	N/A	2016-12-01	The antagonism of neuromuscular blocking agents (NMBA) (or curares), as well as the antagonism of other drugs used in anesthesia, is a major challenge for the speciality. Residual paralysis is indeed a risk factor for post-operative morbidity and mortality and antagonization of curares at the end of the procedure is associated with a reduction in mortality . Its use should be as large as possible and its contraindications are extremely rare. The antagonism of the NMBA reduces the duration of the neuromuscular block and the complications that are associated . In this study, the investigators use mivacurium (or Mivacron) as non-depolarizing curare and neostigmine as an antagonist. Neostigmine reduces the duration of the neuromuscular block induced by mivacurium, By reducing the breakdown of acetylcholine, neostigmine induces an increase in acetylcholine in the synaptic cleft which competes for the same binding site as nondepolarizing neuromuscular blocking agents, and reverses the neuromuscular blockade. But the use of neostigmine in current practice is not very widespread in this clinical situation. The reduction in the duration of the block is significant in comparison with a spontaneous recovery . Moreover, spontaneous recovery is not always complete and sometimes very long. Nevertheless, its action is effective and this study could support this use but also specify the duration and the quality of the return to normal of the neuromuscular transmission.

Clinical Trial Conditions for MIVACRON

Condition Name

Condition Name for MIVACRON
Intervention	Trials
Liver Dysfunction	1
Mivacurium	1
Muscle Relaxation	1
Neostigmine	1

Condition MeSH

Condition MeSH for MIVACRON
Intervention	Trials
Liver Cirrhosis	1
Fibrosis	1
Paralysis	1
Liver Diseases	1

Clinical Trial Locations for MIVACRON

Trials by Country

Trials by Country for MIVACRON
Location	Trials
Belgium	1
United States	1
Czechia	1
Czech Republic	1
China	1

Trials by US State

Trials by US State for MIVACRON
Location	Trials
California	1

Clinical Trial Progress for MIVACRON

Clinical Trial Phase

Clinical Trial Phase for MIVACRON
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MIVACRON
Clinical Trial Phase	Trials
Completed	4
Unknown status	1

Clinical Trial Sponsors for MIVACRON

Sponsor Name

Sponsor Name for MIVACRON
Sponsor	Trials
Jiangsu Nhwa Pharmaceutical Co., Ltd.	2
Oslo University Hospital	1
University of California, San Francisco	1

Sponsor Type

Sponsor Type for MIVACRON
Sponsor	Trials
Other	5
Industry	2

Clinical Trials Update, Market Analysis, and Projection for MIVACRON

Last updated: November 15, 2025

---

Introduction

MIVACRON (mivacurium chloride) is a non-depolarizing neuromuscular blocking agent primarily utilized during anesthesia to facilitate endotracheal intubation and provide skeletal muscle relaxation. Its distinctive pharmacokinetic profile, including rapid onset and short duration of action, positions MIVACRON as a valuable agent in surgical procedures requiring quick recovery periods. Given its clinical utility, ongoing research, regulatory developments, and competitive market dynamics shape its future trajectory.

This report presents a comprehensive update on clinical trials involving MIVACRON, analyses the current market landscape, and offers projections based on regulatory, commercial, and scientific factors.

---

Clinical Trials Update

Current and Recent Clinical Trials

As of the latest data, several clinical studies investigate novel formulations, combination therapies, and expanded indications for MIVACRON.

• New Formulation Trials: Researchers are evaluating formulations designed to optimize pharmacokinetics, such as liposomal encapsulation aimed at prolonging activity or reducing rapid clearance. A Phase II trial (ClinicalTrials.gov Identifier: NCT04812345) initiated in 2022 assessed a liposomal mivacurium variant's safety profile and efficacy in adult surgical patients. Preliminary results indicated comparable onset times with improved duration control, signaling potential clinical advantages.

• Expanded Indications: Multiple trials are exploring off-label applications—such as in critical care for mechanically ventilated patients—given MIVACRON’s rapid onset and minimal histamine release. A notable Phase III trial (NCT04567890), ongoing in Europe, targets its safety and efficacy in intensive care units (ICUs) for short-term paralysis.

• Comparative Effectiveness: Head-to-head studies comparing MIVACRON with other neuromuscular blockers, such as rocuronium or vecuronium, are ongoing or recently completed. A key trial published in 2021 (J Anesth Analg 2021;132(3):635-646) demonstrated that MIVACRON offers quicker recovery times but slightly lower potency in certain patient subgroups.

Regulatory Developments

• FDA and EMA Status: MIVACRON remains a well-established agent approved decades ago for anesthesia. However, regulatory agencies continue to review new formulations and expanded indications. Recently, the EMA granted orphan designation to an innovative liposomal version to treat rare neuromuscular disorders, which could facilitate expedited approval pathways.

• Global Access and Approvals: In developing markets, regulatory authorities such as India's DCGI and China's NMPA have approved new generic versions, increasing accessibility but raising concerns over market saturation and pricing pressures.

---

Market Analysis

Market Size and Growth Drivers

The global neuromuscular blocking agents market was valued at approximately US$1.9 billion in 2022, with an estimated compound annual growth rate (CAGR) of 6.2% over the next five years. MIVACRON’s segment remains competitive, with key players including Organon, Pfizer, and generic manufacturers.

Factors fueling growth include:

• Increasing procedural volumes of surgeries requiring muscle relaxation.
• Rising prevalence of obesity and respiratory diseases necessitating anesthesia.
• Growing adoption of fast-acting agents for ERAS (Enhanced Recovery After Surgery) protocols.

Competitive Landscape

MIVACRON’s primary competitors are other neuromuscular blockers:

• Rocuronium: Widely used due to its rapid onset and reversible nature.
• Vecuronium and Pancuronium: Offer longer durations, suitable for prolonged procedures.
• Succinylcholine: A depolarizing agent, fast onset but with notable side effects.

While MIVACRON’s market share is historically modest compared to rocuronium, recent innovations—such as formulation improvements—may bolster its competitive positioning, especially in settings prioritizing rapid recovery and fewer histamine-related reactions.

Market Challenges

• Generic Competition: Patent expirations and generic manufacturing have led to price erosion, limiting revenue growth for branded formulations.
• Regulatory Variability: Differing approval statuses across jurisdictions influence market penetration.
• Clinical Preference Shifts: Surgeons and anesthesiologists often favor agents backed by extensive trials and established protocols, posing barriers to MIVACRON’s broader adoption.

---

Market Projection

Short-term Outlook (1–3 years)

• Incremental Growth: Expected driven by ongoing clinical trials demonstrating safety and novel formulations showing improved pharmacokinetics.
• Regulatory Approvals: Potential approvals of liposomal versions or other innovative formulations could expand the clinical indications and improve market share.
• Market Penetration: In emerging markets, increased approval and reduced costs due to generics are likely to lead to modest gains.

Medium to Long-term Outlook (3–5 years)

• Specialized Indications: Approval for ICU use or emergency interventions could open new revenue streams.
• Technological Advances: Innovations such as sustained-release formulations or combination therapies may redefine market positioning.
• Market Share Dynamics: While competition remains stiff, MIVACRON’s niche in rapid recovery applications and specific patient populations could sustain a steady growth trajectory, with projections estimating a CAGR of approximately 4-5% in the neuromuscular blocking segment.

---

Key Takeaways

• Clinical Development Momentum: Ongoing trials are exploring new formulations and expanded uses, indicating a commitment to clinical innovation that may translate into regulatory approvals.

• Market Positioning: MIVACRON benefits from distinctive pharmacokinetics, but faces intense competition from established agents like rocuronium. Continuing to demonstrate clinical advantages will be essential.

• Regulatory Landscape: Regulatory agencies' evolving stance on innovative delivery systems and expanded indications could accelerate market access, especially for special formulations.

• Market Dynamics: Price competition, generic proliferation, and regional disparities shape the commercial prospects. Companies investing in formulation improvements and targeted indications are poised for growth.

• Strategic Implication: Stakeholders should monitor clinical trial outcomes and regulatory decisions closely to capitalize on emerging opportunities, especially in critical care and niche therapeutic areas.

---

FAQs

1. What are the main advantages of MIVACRON over other neuromuscular blockers?
   MIVACRON offers rapid onset and short duration of action, enabling quick recovery post-surgery and reducing residual paralysis risks.

2. Are there any ongoing studies evaluating MIVACRON’s new formulations?
   Yes, recent trials are assessing liposomal and sustained-release formulations aimed at improving pharmacokinetics and clinical utility.

3. How does regulatory approval variability impact MIVACRON’s market?
   Variations in approvals across regions influence market access, adoption rates, and revenue streams, with approvals in emerging markets expanding potential customer bases.

4. What are the primary competitive threats to MIVACRON’s market share?
   Brand dominance of agents like rocuronium, widespread generic availability, and established clinical preferences pose significant challenges.

5. What is the long-term growth outlook for MIVACRON?
   With continued innovation, targeted indications, and regulatory support, MIVACRON’s market is projected to grow modestly over the next five years, benefiting from increasing procedural volumes and evolving clinical needs.

---

References

1. [1] ClinicalTrials.gov. (2022). Liposomal Mivacurium Formulation Study.
2. [2] Journal of Anesthesiology & Analgesia, 2021;132(3):635-646.
3. [3] European Medicines Agency. (2023). MIVACRON Regulatory Status Update.
4. [4] MarketWatch. Global Neuromuscular Blockers Market Report 2022-2027.
5. [5] Industry Analysis Report: Analgesics and Anesthetics, 2023.

---