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

505(b)(2) Clinical Trials for Amino Acids; 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; 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.

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

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Healthy	3
Diabetes Mellitus, Type 2	2
Respiratory Distress Syndrome, Adult	2

Condition MeSH

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

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

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
United States	29
Egypt	4
Canada	3
Switzerland	3
United Kingdom	3

Trials by US State

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

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

Clinical Trial Phase

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

Sponsor Name

Sponsor Name for Amino Acids; 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; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
Other	69
Industry	11
NIH	8

Clinical trials update, market analysis and projection for Amino acids + magnesium chloride + potassium chloride + potassium phosphate (dibasic) + sodium chloride injection

Last updated: July 28, 2026

What is the FDA status and Orange Book exclusivity for amino acids + magnesium chloride + potassium chloride + potassium phosphate (dibasic) + sodium chloride?

Core answer: The requested topic is a multi-salt, amino-acid parenteral composition that is typically marketed as an intravenous infusion solution in various branded/generic forms. Patent and exclusivity rights depend on the specific NDC product, manufacturer, and dosage form because the Orange Book is product-specific and does not list a drug “by ingredient pack” alone.

Why the exclusivity read matters

• Parenteral electrolytes are often protected by a mix of:
  • formulation/process patents,
  • container-closure and sterilization/process patents,
  • and, in some cases, patents tied to clinical use (method-of-use).
• FDA exclusivity (3-year/5-year/7-year, orphan, pediatric extensions) is tied to the NDA/BLA and labeling.

Data availability constraint A complete, accurate Orange Book mapping requires the specific FDA product identifiers (NDA/BLA and NDCs) for the exact formulation(s) represented by the ingredient list. Without that product identifier set, exclusivity timelines and Orange Book listings cannot be reported without error.

What clinical trials are active or recently completed for amino acids plus electrolytes (magnesium, potassium, phosphate) plus sodium chloride?

Core answer: For amino-acid/electrolyte IV solutions, clinical programs are often limited to:

• formulation comparability,
• stability and reconstitution/compatibility studies,
• and occasionally post-approval observational or safety studies. Large Phase 3 programs are less common because these products are generally used as supportive/adjunct therapy rather than single-compound disease drugs.

Typical trial patterns for this category

• PK/compatibility studies in specific populations (ICU, pediatrics, renal impairment).
• Safety and tolerability for infusion, electrolytes, and acid-base balance.
• Stability and container compatibility to support shelf-life and manufacturing changes.

Data availability constraint A “clinical trials update” with credible granularity (trial identifiers, sponsor, endpoints, enrollment, completion dates) requires the exact drug name as listed in ClinicalTrials.gov or other registries. The ingredient list alone is not sufficient to uniquely identify the filing-level product.

How large is the market for IV amino acids plus magnesium, potassium, phosphate, and sodium chloride?

Core answer: The addressable market is the global parenteral nutrition and supportive electrolyte infusion segment, with revenue pulled by:

• hospital and ICU utilization,
• parenteral nutrition protocols,
• surgical volume and critical care length of stay,
• and access and reimbursement dynamics for IV admixtures versus premix solutions.

Market sizing requires product-level mapping To quantify market size and share by:

• exact premix versus admixture,
• adult versus pediatric,
• and branded versus generic, the drug must be mapped to:
• a specific product class on IQVIA/PA/claims datasets,
• or an identified listing of marketed SKUs.

Data availability constraint No credible numeric market size and share projections can be produced from the ingredient list without the underlying product mapping (NDC/NDA and marketed SKU set).

What market projection should be used for amino-acid electrolyte IV solutions through 2030?

Core answer: Growth for amino-acid and electrolyte IV solutions generally tracks:

• growth in hospital admissions and ICU patient days,
• replacement of multi-component manual admixtures by premixed products (workflow and safety),
• and incremental uptake in perioperative and chronic-care settings.

Projection model depends on segmentation A defensible projection requires at least:

• geography (US vs EU vs emerging markets),
• setting (hospital vs home infusion),
• and competitive set (branded premix vs repackagers vs generics).

Data availability constraint A numeric projection table (base case, bull case, bear case) cannot be generated without market baseline and competitive set identifiers linked to the exact product.

Which patents protect amino acids + magnesium chloride + potassium chloride + potassium phosphate (dibasic) + sodium chloride formulations?

Core answer: For multi-salt amino-acid infusion solutions, patent estates typically include:

• composition of matter or formulation patents,
• method-of-manufacture and sterilization/process patents,
• container closure system patents,
• and stability/compatibility patents (including admixture compatibility).

Data availability constraint Patent coverage must be tied to:

• an exact product NDA/BLA (or specific marketed label),
• and then searched across USPTO/EP/WO with assignee and formulation claim targeting. Without the product identifiers, an accurate “what patents protect” list cannot be produced.

When does exclusivity or patents for this electrolyte amino-acid IV solution lose protection?

Core answer: The exclusivity/patent loss date is product-specific:

• Orange Book exclusivity periods apply to the NDA/BLA.
• Patent expiry depends on the specific listed patents (or unlisted patents via litigation).

Data availability constraint Without the specific NDA/BLA (and Orange Book listing set), this timing cannot be stated accurately.

What generic entry risks exist for amino-acid electrolyte IV solutions?

Core answer: Generic entry risks typically come from:

• Para-IV filings against listed patents (if Orange Book-listed products exist for that formulation),
• and manufacturing/label changes that avoid infringement while preserving therapeutic equivalence.

Data availability constraint A generic-entry risk assessment depends on:

• whether the reference product has Orange Book listed patents,
• whether ANDA filers have filed Paragraph IV,
• and whether settlements exist.

Those facts require product identifiers and the Orange Book/ANDA litigation record.

How does the competitive landscape differ: premixed multi-electrolyte IV solutions vs pharmacy-compounded admixtures?

Core answer: Premixed products compete against:

• hospital pharmacy admixture workflows,
• compounding outsourced services,
• and generic premix solutions.

Key differentiators

• shelf-life and stability,
• cost and procurement contracting,
• ease of administration and dosing precision,
• and compatibility with concomitant infusions.

Data availability constraint A competition map requires SKU-level competitor identification by NDC and manufacturer.

What is the likelihood of biosimilar-style disruption for this amino-acid electrolyte IV solution?

Core answer: Biosimilars do not generally apply to small-molecule IV electrolyte/amino-acid solutions. The relevant disruption mode is typically generics and reformulated premixes.

Data availability constraint No additional probability modeling can be done without the exact regulatory class and reference product identification.

Clinical endpoints and safety considerations that affect trials and labeling

Core answer: For amino-acid plus electrolyte infusions, label and trial endpoints commonly involve:

• serum electrolyte changes (K, Mg, phosphate, chloride, sodium),
• acid-base balance,
• infusion tolerability (phlebitis, reactions),
• and safety in renal impairment.

These factors drive labeling differences and can limit substitution even where generics are available.

Data availability constraint Specific endpoint and label wording updates cannot be tied to your exact ingredient set without product identification.

Revenue and R&D pipeline implications: what to monitor

Core answer: For this therapeutic-support category, the main investment and licensing watchpoints are:

• manufacturing changes and facility approvals,
• stability-extension filings,
• ANDA/Para-IV filing activity,
• and settlement/litigation outcomes tied to formulation/process patents.

Data availability constraint No actionable timeline of filings or litigation events can be listed without identifying the exact product(s) and their patent/ANDA families.

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Key Takeaways

• The ingredient list describes a parenteral amino-acid plus electrolytes IV solution, but clinical, exclusivity, patent, and market answers are product-specific.
• A credible “clinical trials update” and “market projection” require mapping to the exact FDA product identity (NDA/BLA and NDC/SKU set); otherwise timelines, competitors, and numeric forecasts would not be accurate.
• Patent protection and generic entry risk in this space typically focus on formulation/process/stability and label-specific product definitions.

FAQs

1. How are electrolyte-amino acid IV solutions categorized in market datasets (parenteral nutrition vs supportive electrolytes)?
2. What regulatory pathways apply to premixed electrolyte amino-acid solutions (NDA vs ANDA vs 505(b)(2))?
3. Which product attributes (osmolality, concentration ranges, container closure) most often drive differentiation between generic and branded versions?
4. How do renal impairment and ICU electrolyte protocols influence clinical study design for amino-acid/electrolyte infusions?
5. What litigation pattern is most common for parenteral electrolyte premix products: formulation/process patents or container-closure patents?

References

1. ClinicalTrials.gov. (n.d.). Database. https://clinicaltrials.gov
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm