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

505(b)(2) Clinical Trials for AMINO ACIDS; MAGNESIUM 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; MAGNESIUM 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; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Condition Name

Condition Name for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Intervention	Trials
Healthy	3
Diabetic Ketoacidosis	2
Nephrolithiasis	2
Hypercalciuria	2

Condition MeSH

Condition MeSH for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Intervention	Trials
Nephrolithiasis	6
Kidney Calculi	6
Hypercalciuria	3
Calculi	3

Clinical Trial Locations for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Trials by Country

Trials by Country for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Location	Trials
United States	29
Egypt	4
India	3
Canada	3
Switzerland	3

Trials by US State

Trials by US State for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Location	Trials
California	3
Minnesota	3
Maryland	3
Illinois	2
Texas	2

Clinical Trial Progress for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	23
Not yet recruiting	7
RECRUITING	6

Clinical Trial Sponsors for AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Sponsor Name

Sponsor Name for AMINO ACIDS; MAGNESIUM 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; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
Sponsor	Trials
Other	69
Industry	11
NIH	8

Last updated: May 25, 2026

Executive summary

No patent- or FDA-exclusivity-relevant answer can be produced for this drug entry because the input does not identify a specific proprietary product, developer, NDC, dosage form (oral vs IV), branded name, or active-ingredient concentration regimen. “Amino acids + magnesium chloride + potassium phosphate dibasic + sodium chloride” describes an excipient-and-salt combination used across multiple nutrition/infusion products, each with distinct formulations, trial programs, and regulatory status. Without a uniquely identifying product label, any “clinical trials update,” “Orange Book status,” or “market projection” would be non-actionable.

Clinical trials update for “Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride”

No complete and accurate clinical-trials update can be generated from the ingredient-only description. Clinical development is product-specific (formulation strength, infusion route, osmolarity, compatible electrolytes, and indication). Trial registries and publications do not map reliably to the ingredient string alone.

What do clinical trials for this ingredient basket usually target?

These combinations are typically used in:

• Parenteral nutrition (amino acid infusions with electrolytes)
• Electrolyte replacement in clinical nutrition contexts
• Supportive inpatient regimens (hospital formularies)

Ingredient basket overlap across multiple brands prevents a single coherent update without a product identity.

Market analysis and projection for “Amino Acids; Magnesium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride”

A market model requires at least one of: branded product name, NDC, route/dosage form, or manufacturer. Ingredient-only queries span multiple marketed products and therapeutic uses, making demand, pricing, payer coverage, and competitive substitution impossible to quantify accurately.

What market sizing inputs are product-specific here?

• Route: IV infusion vs other administration
• Intended use: parenteral nutrition vs electrolyte support protocols
• Strength and packaging: volumes, amino-acid concentration, electrolytes per unit
• Geographic coverage and hospital procurement contracting
• Competitors: branded nutrition brands, private label, and generic/authorized equivalents

Key Takeaways

• The provided “drug” definition is not uniquely identifying, so no defensible clinical-trials update or market projection can be produced.
• Product-level identifiers (brand/NDC/formulation/route) are required to avoid mixing distinct programs and distinct marketed products.

FAQs

1. How do I confirm the FDA status of an amino-acid/electrolyte infusion product without a brand name?
   You cannot map status reliably from ingredient strings; FDA listings and exclusivity are tied to specific products.

2. Are ingredient-level combinations protected by patents in the same way as branded products?
   Patent estates generally attach to specific compositions, processes, and concentrations tied to a particular product family, not the generic ingredient string.

3. Can market projections be built from hospital parenteral nutrition demand alone?
   Not without mapping which specific branded/authorized infusion SKUs carry the demand and pricing.

4. Do clinical trials for parenteral nutrition electolyte/amino-acid mixes share endpoints across products?
   Endpoints and comparators can differ by formulation and indication; registry mapping is product-specific.

5. What drives substitution risk for amino-acid electrolyte infusions?
   Formulation compatibility, dosing equivalence, procurement contracts, and product availability, all of which are SKU-level.

References

(No sources were cited because the input does not identify a specific product or regulatory entry.)