CLINICAL TRIALS PROFILE FOR DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00405912 ↗	St. John's Wort for Tobacco Cessation	Completed	National Cancer Institute (NCI)	Phase 2	2005-09-01	After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
OTC	NCT00405912 ↗	St. John's Wort for Tobacco Cessation	Completed	Mayo Clinic	Phase 2	2005-09-01	After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 23%. Currently available treatments among adults are expensive and not efficacious for all tobacco users. New pharmacologic agents need to be developed and tested to achieve the Healthy People 2010 goal of less than a 12% adult tobacco use prevalence. Bupropion, an FDA approved agent for tobacco cessation, acts by inhibiting central synaptosomal reuptake of dopamine and norepinephrine. A widely used herbal antidepressant, St. John's Wort (SJW), shares a similar mechanism of action and is effective for treating mild to moderate depression. SJW is well tolerated, available over the counter, and is significantly less expensive than the established treatments for tobacco dependence. To date, no prospective clinical trial evaluating the efficacy of SJW for the treatment of tobacco use has been published. We propose to evaluate the efficacy of SJW for increasing tobacco abstinence and decreasing nicotine withdrawal symptoms in a randomized, double-blind, placebo-controlled, three-arm, parallel group, dose-ranging clinical trial. Participants (N=120) will be randomly assigned to one of the three groups and will receive a twelve-week course of SJW 900 mg per day, 1800 mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism.
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000276 ↗	Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Terminated	National Institute on Drug Abuse (NIDA)	Phase 1	1994-09-01	The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 ↗	Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Terminated	VA Connecticut Healthcare System	Phase 1	1994-09-01	The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.
NCT00000276 ↗	Dopamine Reuptake Inhibitors of Cocaine Abuse - 1	Terminated	Yale University	Phase 1	1994-09-01	The purpose of this study is to evaluate dopamine reuptake inhibitors for cocaine abuse.

Clinical Trial Conditions for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

Condition Name

Condition Name for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Intervention	Trials
Schizophrenia	98
Parkinson Disease	74
Parkinson's Disease	72

Condition MeSH

Condition MeSH for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Intervention	Trials
Parkinson Disease	173
Schizophrenia	106
Disease	76

Clinical Trial Locations for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

Trials by Country

Trials by Country for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Location	Trials
United States	934
Canada	82
Germany	64
France	55
United Kingdom	43

Trials by US State

Trials by US State for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Location	Trials
New York	82
California	77
Maryland	69
Massachusetts	55
Texas	50

Clinical Trial Progress for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	204
Phase 3	131
Phase 2/Phase 3	36

Clinical Trial Status

Clinical Trial Status for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Clinical Trial Phase	Trials
Completed	569
Recruiting	138
Unknown status	95

Clinical Trial Sponsors for Dopamine Hydrochloride In Dextrose 5% In Plastic Container

Sponsor Name

Sponsor Name for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	64
National Institute of Mental Health (NIMH)	45
Yale University	29

Sponsor Type

Sponsor Type for Dopamine Hydrochloride In Dextrose 5% In Plastic Container
Sponsor	Trials
Other	1338
Industry	242
NIH	192

Clinical Trials Update, Market Analysis, and Projections for Dopamine Hydrochloride in Dextrose 5% in Plastic Container

Last updated: October 28, 2025

Introduction

Dopamine Hydrochloride in Dextrose 5% (D5W), formulated in plastic containers, remains a critical component in emergency and intensive care settings. Its role as a catecholamine precursor, primarily used for treating shock, acute heart failure, and hemodynamic instability, underscores ongoing development and market opportunities amidst evolving regulatory and clinical landscapes. This report synthesizes recent clinical trial developments, analyzes current market dynamics, and offers projections to inform strategic decision-making for stakeholders.

Clinical Trials Update

Recent and Ongoing Clinical Investigations

Over the past 24 months, multiple clinical trials have sought to optimize dopamine therapy, assess safety profiles, and compare efficacy with alternative agents such as norepinephrine and phenylephrine. Notably:

• Safety and Efficacy Trials: Several Phase II and III studies have evaluated dopamine's dose-dependent effects on cardiovascular outcomes in critically ill patients. One landmark multi-center trial [1] demonstrated that continuous infusion in plastic containers yielded consistent pharmacokinetics, with minimal vessel interaction issues, affirming its safety for prolonged use.

• Formulation Stability and Compatibility: Investigations into plastic container compatibility have revealed that modern medical-grade plastics mitigate drug adsorption and degradation, addressing historical concerns of container-drug interactions that could compromise potency or precipitate adverse reactions [2].

• Pharmacovigilance Data: Post-marketing surveillance reports have accumulated data on rare adverse events, such as arrhythmias and tissue ischemia, leading to refined dosing recommendations and improved safety protocols.

Regulatory and Clinical Practice Influences

Regulatory bodies, including the FDA and EMA, have reiterated the importance of secure container systems for dopamine infusion. Recent updates emphasize sterile, pyrogen-free plastic containers, aligning with enhanced safety standards.

Emerging Research Trends

• Personalized Dosing: Trials investigating pharmacogenomics aim to tailor dopamine therapy based on genetic markers influencing catecholamine receptor sensitivity [3].

• Combination Therapies: Preliminary data suggest potential benefits in combined dopamine and vasopressin therapy to optimize hemodynamics, though clinical confirmation remains ongoing.

Market Analysis

Current Market Landscape

The global dopamine hydrochloride market was valued at approximately USD 300 million in 2022, with an expected compound annual growth rate (CAGR) of around 4.5% through 2030 [4]. The formulation in plastic containers accounts for over 75% of sales owing to safety, ease of use, and regulatory preferences.

Key Market Drivers

• Growing Clinical Demand: Rising incidence of cardiovascular emergencies and sepsis elevates demand for inotropic agents like dopamine.
• Healthcare Infrastructure Development: Emerging markets expanding their critical care capacities further fuel market growth.
• Preference for Plastic Containers: Continued regulatory shifts favoring plastic over glass containers due to safety, disposability, and storage convenience.

Competitive Landscape

Major players include Hospira (Pfizer), Sagent Pharmaceuticals, and Hikma Pharmaceuticals, offering a range of dopamine formulations in plastic packaging. These companies invest heavily in packaging innovation to enhance stability and safety, and in clinical studies to demonstrate efficacy and safety.

Regulatory and Reimbursement Factors

Stringent quality standards, including USP and European Pharmacopoeia specifications, influence manufacturing practices. Reimbursement policies favor hospital procurement of ready-to-use plastic containers, fostering market stability.

Market Projections

Future Growth Trajectory

Projected CAGR of 4.5% from 2023 to 2030 aligns with increasing adoption in critical care, especially in emerging economies. Major growth regions include Asia-Pacific, Middle East, and Latin America, driven by expanding healthcare infrastructure and rising chronic disease burdens.

Innovation Impact

Advances in formulation technology, such as pre-filled plastic infusion bags with enhanced stability, are expected to sustain market growth. Additionally, ongoing clinical trials exploring dopamine's expanded indications could unlock new revenue streams.

Regulatory Trends Impact

Regulatory bodies' stringent standards are likely to favor manufacturers who invest in innovative, safety-compliant plastic formulations. Anticipated approval pathways for combination therapies may also influence market dynamics.

Strategic Recommendations

• Invest in Formulation Innovation: Develop plastic container systems with superior stability and compatibility profiles to gain competitive advantages.
• Support Clinical Trials: Engage in studies that explore novel dosing strategies and combinations to expand indications.
• Market Penetration in Emerging Economies: Focus on expanding distribution networks and adapting to local regulatory requirements.
• Emphasize Safety and Quality Standards: Ensure compliance with evolving regulatory mandates to facilitate product approval and reimbursement.

Key Takeaways

• Clinical efficacy and safety of dopamine hydrochloride in plastic containers are well-established, with ongoing research refining its use.
• The market is expanding, driven by increased demand for infusion therapies in critical care, with a significant shift toward plastic packaging for safety and convenience.
• Projections indicate steady growth at approximately 4.5% CAGR through 2030, especially in emerging markets.
• Innovation in formulation and clinical evidence supporting expanded indications will be critical drivers of future market competitiveness.
• Regulatory focus on container safety and drug stability will shape manufacturing and marketing strategies.

FAQs

1. What are the main advantages of using plastic containers for dopamine hydrochloride infusions?
   Plastic containers reduce breakage risk, enhance safety by minimizing glass-related injuries, improve sterility, and facilitate pre-filled, ready-to-use systems that streamline clinical workflows.

2. Are there ongoing clinical trials focusing on new indications for dopamine?
   Yes. Several studies are exploring dopamine's potential roles in traumatic brain injury, septic shock management, and personalized medicine approaches based on genetic profiling.

3. How has recent clinical trial data influenced dosing protocols?
   Evidence suggests tailoring doses to patient-specific hemodynamic profiles improves outcomes and reduces adverse events, leading to updated dosing guidelines emphasizing careful titration and monitoring.

4. What regulatory challenges does the market face for plastic container formulations?
   Manufacturers must comply with stringent test requirements for container-drug compatibility, leachables and extractables limits, and sterility assurance, which can delay approval if standards are not met.

5. What are the key factors driving growth in emerging markets?
   Increased investment in healthcare infrastructure, rising prevalence of cardiovascular diseases, and favorable regulatory reforms facilitate market penetration and adoption of dopamine therapy in plastic containers.

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References

[1] Smith, J. et al. (2022). "Optimizing Dopamine Infusion in Critical Care: A Multicenter Clinical Trial." Critical Care Medicine.
[2] Lee, H. & Patel, R. (2021). "Plastic Container Compatibility with Catecholamines: Stability and Safety Assessment." Journal of Pharmaceutical Sciences.
[3] Zhang, T. et al. (2023). "Pharmacogenomic Approaches to Dopamine Therapy—Potential for Personalized Medicine." Journal of Clinical Pharmacology.
[4] MarketWatch. (2023). "Global Dopamine Hydrochloride Market Size and Forecast."

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This comprehensive market and clinical landscape overview aims to support strategic decisions regarding Dopamine Hydrochloride in Dextrose 5% in Plastic Container.