CLINICAL TRIALS PROFILE FOR AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

505(b)(2) Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

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
New Formulation	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).

All Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	University of Texas	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284 ↗	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Center for Research Resources (NCRR)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00120731 ↗	Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones	Withdrawn	Children's Mercy Hospital Kansas City	N/A	2005-07-01	High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years: - children who are hypercalciuric stone formers; - healthy children without a history of hypercalciuria or kidney stones. Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction. The researchers will try to learn whether it is the child's characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better "tailor" the individual treatment for each child with kidney stones.
NCT00291720 ↗	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	British Heart Foundation	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure
NCT00291720 ↗	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	University Hospital Birmingham	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure

Clinical Trial Conditions for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Condition Name

Condition Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Healthy	3
Nephrolithiasis	2
Diabetes	2
Hypercalciuria	2

Condition MeSH

Condition MeSH for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	6
Hypercalciuria	3
Calculi	3

Clinical Trial Locations for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Trials by Country

Trials by Country for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
United States	29
Canada	3
Switzerland	3
Egypt	3
United Kingdom	3

Trials by US State

Trials by US State for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
California	3
Minnesota	3
Maryland	3
Pennsylvania	2
Massachusetts	2

Clinical Trial Progress for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	4
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	7
Terminated	5

Clinical Trial Sponsors for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride

Sponsor Name

Sponsor Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
University of Minnesota	3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
Rigshospitalet, Denmark	2

Sponsor Type

Sponsor Type for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
Other	64
Industry	9
NIH	8

Clinical Trials, Market Analysis, and Projections for Amino Acids, Dextrose, Magnesium Chloride, Potassium Chloride, Potassium Phosphate, Dibasic, and Sodium Chloride

Overview of the Drug Combination

The drug combination of amino acids, dextrose, magnesium chloride, potassium chloride, potassium phosphate (dibasic), and sodium chloride is a multifaceted formulation used primarily in parenteral nutrition and to manage various electrolyte and nutritional deficiencies. This combination is crucial in clinical settings, particularly for patients who require intravenous nutrition due to their inability to absorb nutrients through the gastrointestinal tract.

Clinical Trials Update

Current Status

The clinical trials for this drug combination have largely been completed, with several formulations already approved and in use. For instance, Aminosyn II With Electrolytes, which includes amino acids, magnesium chloride, potassium chloride, potassium phosphate (dibasic), and sodium chloride, has been approved by regulatory bodies such as the FDA since the late 1980s and early 1990s[4][5].

Historical Context

These formulations have undergone extensive clinical trials to establish their safety and efficacy. The trials have focused on various aspects, including the optimal concentration of electrolytes, the impact on metabolic and endocrine functions, and the management of nutrition disorders. However, many of these trials are now in the post-marketing phase, with ongoing monitoring for adverse effects and long-term outcomes[1][3][4].

Recent Developments

There have been no recent clinical trials initiated for new indications, as the primary focus has shifted to optimizing existing formulations and managing shortages of key components, such as potassium phosphate. The use of multi-chamber bag parenteral nutrition (MCB-PN) solutions has been a significant development, helping to conserve resources and reduce costs during periods of electrolyte shortages[2].

Market Analysis

Market Demand

The demand for parenteral nutrition solutions, including this drug combination, remains steady due to the ongoing need for intravenous nutrition in clinical settings. The market is driven by the increasing number of patients requiring long-term nutritional support, such as those with severe gastrointestinal disorders or undergoing major surgeries.

Market Size and Growth

The global parenteral nutrition market is projected to grow significantly over the next few years, driven by advancements in healthcare infrastructure and an increasing awareness of nutritional therapy. The market size is expected to expand due to the rising incidence of chronic diseases and the growing elderly population, which often requires more intensive nutritional support[4].

Competitive Landscape

The market for parenteral nutrition solutions is competitive, with several key players such as Abbott Laboratories, Baxter Healthcare Corp., and Hospira, Inc. These companies have a strong presence in the market and continue to innovate and optimize their formulations to meet clinical needs. The competitive landscape is also influenced by regulatory approvals, product differentiation, and cost-effectiveness[1][3][4].

Market Projections

Future Trends

The future of parenteral nutrition is likely to be shaped by advancements in personalized medicine and the development of more tailored nutritional solutions. There will be a greater emphasis on optimizing electrolyte concentrations and reducing the risk of acid-base disorders, which are common complications in parenteral nutrition[2].

Economic Projections

The economic projections for this market segment are positive, with expected growth driven by increasing healthcare expenditures and the need for advanced nutritional therapies. The cost savings achieved through the use of MCB-PN solutions during periods of electrolyte shortages are also expected to contribute to the overall market growth[2].

Regulatory Environment

Approval Status

The drug combination of amino acids, dextrose, magnesium chloride, potassium chloride, potassium phosphate (dibasic), and sodium chloride has been approved in various jurisdictions, including the US, since the late 1980s and early 1990s. These approvals are based on extensive clinical trials and regulatory reviews[1][3][4].

Regulatory Challenges

One of the significant regulatory challenges faced by manufacturers is managing the supply chain during periods of component shortages. For example, the shortage of potassium phosphate has necessitated the development of alternative formulations and the use of MCB-PN solutions to conserve resources[2].

Therapeutic Areas and Indications

Endocrinology and Metabolic Disease

This drug combination is primarily used in the therapeutic areas of endocrinology and metabolic disease. It is indicated for the management of nutrition disorders, particularly in patients who require parenteral nutrition due to their inability to absorb nutrients through the gastrointestinal tract[1][3][4].

Active and Inactive Indications

The active indications include the management of severe malnutrition, post-surgical nutritional support, and the treatment of electrolyte imbalances. Inactive indications, such as general nutritional support without specific electrolyte imbalances, are less common but still relevant in certain clinical contexts[1][3][4].

Key Takeaways

• Clinical Trials: The clinical trials for this drug combination are largely completed, with a focus on post-marketing surveillance.
• Market Analysis: The market demand is steady, driven by the need for intravenous nutrition in clinical settings.
• Market Projections: The market is expected to grow due to advancements in healthcare and the increasing need for personalized nutritional solutions.
• Regulatory Environment: The drug combination is approved in various jurisdictions, with ongoing regulatory oversight to manage component shortages.
• Therapeutic Areas: The primary therapeutic areas include endocrinology and metabolic disease, with indications for managing nutrition disorders and electrolyte imbalances.

FAQs

What is the primary use of the drug combination of amino acids, dextrose, magnesium chloride, potassium chloride, potassium phosphate (dibasic), and sodium chloride?

The primary use is for parenteral nutrition to manage nutrition disorders and electrolyte imbalances in patients who cannot absorb nutrients through the gastrointestinal tract.

Which companies are key players in the market for this drug combination?

Key players include Abbott Laboratories, Baxter Healthcare Corp., and Hospira, Inc.

How have electrolyte shortages impacted the market for this drug combination?

Electrolyte shortages, particularly of potassium phosphate, have led to the development of alternative formulations and the use of MCB-PN solutions to conserve resources and reduce costs.

What are the future trends in the market for parenteral nutrition solutions?

Future trends include advancements in personalized medicine, optimization of electrolyte concentrations, and a greater emphasis on reducing the risk of acid-base disorders.

What is the expected market growth for parenteral nutrition solutions?

The market is expected to grow significantly due to increasing healthcare expenditures and the need for advanced nutritional therapies.

Sources

1. Patsnap Synapse: Amino Acids/Dextrose/Magnesium chloride/Potassium acetate/Potassium chloride/Potassium phosphate, dibasic/Sodium chloride.
2. ASPEN: Metabolic Support in the Era of Fluid and Electrolyte Shortages.
3. Patsnap Synapse: Amino Acids/Dextrose/Magnesium chloride/Potassium phosphate, dibasic/Sodium acetate/Sodium chloride.
4. Patsnap Synapse: Amino Acids/Dextrose/Magnesium chloride/Potassium chloride/Potassium phosphate, dibasic/Sodium chloride.
5. Federal Register: Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride) Injection.