CLINICAL TRIALS PROFILE FOR NEOSTIGMINE METHYLSULFATE PFS

All Clinical Trials for Neostigmine Methylsulfate Pfs

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01050543 ↗	Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2010-02-01	This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.
NCT02279147 ↗	Cholinergic Anti-inflammatory Pathway in Prevention & Treatment of the SIRS in Patients With Jaundice After Operation.	Unknown status	Wanqing Gu	Phase 1/Phase 2	2014-08-01	RATIONALE:Anticholinesterase drugs and cholinergic M receptor antagonist are applied to patients who have obstructive jaundice after operation. PURPOSE:This clinical trial was designed to lower the incidence and mortality of operation complications in patients with obstructive jaundice .
NCT02370433 ↗	Use of Prokinetics During Inpatient Bowel Care for SCI Patients	Unknown status	James J. Peters Veterans Affairs Medical Center	Phase 1	2012-12-01	Bowel care (BC) is a time-consuming and cumbersome activity of daily living for most individuals with SCI. Previous studies have reported that the average time to complete a BC routine is 45 minutes; 10-20% of SCI individuals report BC routines lasting for more than 1 hour. In past studies, the investigators have shown that a medication called neostigmine can increase bowel activity and thus, promote bowel movement. The investigators have successfully used this medication with traditional and novel methods of colonoscopic preparations, and have shown that it improves the quality of these preparations. In this study, we would like to test the applicability of this medication to bowel care routines. The investigators believe that the addition of this medication to the beginning of regular bowel regiments will significantly decrease the time and effort needed to complete BC, thus improving patient perception of their BC routines and quality of life. SCI individuals followed by the James J Peters VA Medical Center (JJPVAMC) SCI Medical Service are admitted on a routine basis for inpatient respite care, therapy, and/or annual physicals. Such inpatient stays typically range in duration from 1 week to 3 weeks, during which the patient undergo BC routines assisted by the inpatient care team. BC routines are typically performed every other day, or thrice weekly (Monday, Wednesday, Friday) in "Blue Rooms" located on the inpatient SCI wards (IE and ID). The bowel care routine, including duration of procedure, use of assistive medications or devices, and completeness of bowel care are documented in the patients' electronic medical chart (CPRS) by care providers. The investigators propose to perform the described protocol in individuals who have been admitted to the hospital for routine care and are otherwise healthy. In doing so, the investigators can ensure that patients are vigilantly monitored during each BC session, and that any changes in BC pattern are accurately observed and documented. Furthermore, by performing these procedures on an inpatient basis, study investigators can ensure the consistency of care and daily routine, allowing for better control of study conditions.

Clinical Trial Conditions for Neostigmine Methylsulfate Pfs

Condition Name

Condition Name for Neostigmine Methylsulfate Pfs
Intervention	Trials
Post-Dural Puncture Headache	2
Snoring	1
Spinal Cord Injury	1

Condition MeSH

Condition MeSH for Neostigmine Methylsulfate Pfs
Intervention	Trials
Post-Dural Puncture Headache	2
Headache	2
Systemic Inflammatory Response Syndrome	1

Clinical Trial Locations for Neostigmine Methylsulfate Pfs

Trials by Country

Trials by Country for Neostigmine Methylsulfate Pfs
Location	Trials
United States	2
China	2
Egypt	2
Korea, Republic of	1
Italy	1

Trials by US State

Trials by US State for Neostigmine Methylsulfate Pfs
Location	Trials
Georgia	1
New York	1

Clinical Trial Progress for Neostigmine Methylsulfate Pfs

Clinical Trial Phase

Clinical Trial Phase for Neostigmine Methylsulfate Pfs
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Neostigmine Methylsulfate Pfs
Clinical Trial Phase	Trials
Completed	3
Unknown status	3
Terminated	1

Clinical Trial Sponsors for Neostigmine Methylsulfate Pfs

Sponsor Name

Sponsor Name for Neostigmine Methylsulfate Pfs
Sponsor	Trials
Fayoum University Hospital	2
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	1
Alexandria University	1

Sponsor Type

Sponsor Type for Neostigmine Methylsulfate Pfs
Sponsor	Trials
Other	10
Industry	1
U.S. Fed	1

Neostigmine Methylsulfate Injection: Clinical Trials, Market Analysis, and Projections

Last updated: January 7, 2025

Introduction to Neostigmine Methylsulfate Injection

Neostigmine methylsulfate is a reversible cholinesterase inhibitor used primarily in clinical settings to reverse the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery. It works by inhibiting the enzyme acetylcholinesterase, allowing acetylcholine to accumulate and stimulate skeletal muscle[2][4][5].

Clinical Trials and Safety Profile

Clinical Trials Experience

The clinical trials for neostigmine methylsulfate have been conducted under various conditions, and the adverse reaction rates observed cannot be directly compared to those of other drugs. However, quantitative adverse event data from trials involving 200 adult patients have been documented. These trials indicate that adverse reactions are often due to exaggerated pharmacological effects, particularly at muscarinic receptor sites. Common adverse reactions include those that can be mitigated by the use of anticholinergic agents like atropine sulfate or glycopyrrolate[4].

Recent Developments: Fixed Dose Combination

A recent development involves the approval of a fixed dose combination of neostigmine methylsulfate and glycopyrrolate. This combination, submitted under NDA 216903, aims to provide a convenient and streamlined option for clinicians to reverse NMBAs. The FDA review highlighted several benefits, including reduced administration steps, familiarity for anesthesia providers, and adequate risk mitigation for potential adverse effects such as bradycardia. This combination relies on previous findings of safety and effectiveness for the individual drugs and does not require new clinical efficacy studies[1].

Market Analysis

Market Size and Growth

The global neostigmine methylsulfate injection market is projected to experience significant growth over the coming years. As of 2022, the market size was valued at approximately USD 156.54 million and is expected to reach USD 228.43 million by 2031, growing at a CAGR of 4.4% during the forecast period of 2023-2031[5].

Regional Insights

The North American region holds a significant revenue share in the neostigmine methylsulfate injection market. This is driven by increasing research and development, as well as rising FDA approvals for various competitors. The market in this region is anticipated to continue growing due to these factors[5].

Market Drivers

Several factors propel the growth of the neostigmine methylsulfate injection market:

• Critical Role in Anesthesia Management: Neostigmine's ability to effectively reverse NMBAs is indispensable in surgical settings, driving demand.
• Increasing Surgical Procedures: The global increase in surgical procedures, fueled by population growth and advancements in medical technologies, contributes to sustained demand.
• Efficacy and Safety Profile: When administered by experienced healthcare professionals, neostigmine's established efficacy and safety profile solidifies its position in the market[2][3].

Market Constraints

Despite the growth drivers, there are several factors that can impede market growth:

• Potential Side Effects: Although infrequent, potential side effects and adverse reactions necessitate careful monitoring and prompt intervention by healthcare providers.
• Specialization Requirements: The high degree of specialization required for administering neostigmine may limit its accessibility in certain healthcare settings, particularly those with limited resources or inexperienced staff[2].

Market Projections

Forecast Period

The market is expected to grow at a CAGR of 4.4% to 4.72% during the forecast period of 2023-2031. By 2031, the market is projected to reach a value of USD 228.43 million to USD 213.3 million, depending on the source[3][5].

Segment Analysis

The market growth is also influenced by various segments such as:

• By Application: The demand for neostigmine methylsulfate is high in surgical settings for reversing NMBAs.
• By Distribution Channel: Hospital pharmacies are expected to grow rapidly due to increasing hospitalizations for conditions like myasthenia gravis.
• By End User: The elderly population, more prone to neurological conditions, drives the demand for neostigmine methylsulfate injections in hospitals[2][5].

Key Takeaways

• Neostigmine methylsulfate injection is a crucial pharmaceutical in anesthesia management, used to reverse the effects of NMBAs.
• The market is expected to grow significantly, driven by its critical role in surgical settings and increasing surgical procedures.
• The North American region holds a significant revenue share due to research and development and FDA approvals.
• Potential side effects and the need for specialized administration can limit market growth in certain settings.

FAQs

1. What is the primary use of Neostigmine Methylsulfate Injection?

Neostigmine methylsulfate injection is primarily used to reverse the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.

2. What are the benefits of the fixed dose combination of Neostigmine Methylsulfate and Glycopyrrolate?

The fixed dose combination reduces the number of administration steps, leverages the familiarity of anesthesia providers with NMBA reversal, and includes adequate risk mitigation for potential adverse effects like bradycardia[1].

3. What drives the growth of the Neostigmine Methylsulfate Injection market?

The growth is driven by its critical role in anesthesia management, increasing surgical procedures, and the established efficacy and safety profile when administered by experienced healthcare professionals[2][3].

4. What are the potential constraints to the market growth?

Potential side effects, the need for careful monitoring, and the high degree of specialization required for administration can limit market growth in certain healthcare settings[2].

5. What is the projected market size of Neostigmine Methylsulfate Injection by 2031?

The market is projected to reach a value of USD 228.43 million to USD 213.3 million by 2031, growing at a CAGR of 4.4% to 4.72% during the forecast period[3][5].

Cited Sources:

1. FDA Summary Review NDA 216903

   • Neostigmine methylsulfate 3 mg/3 mL (1 mg/mL), glycopyrrolate 0.6 mg/3 mL (0.2 mg/mL) PFS[1].

2. FutureWise Market Research

   • Neostigmine Methylsulfate Injection Market Overview[2].

3. Coherent Market Insights

   • Neostigmine Methylsulfate Injection Market Size and Trends[3].

4. DailyMed

   • Label: NEOSTIGMINE METHYLSULFATE injection[4].

5. InsightAce Analytic

   • Neostigmine Methylsulfate Injection Market Share, Size, Growth and Forecast[5].