CLINICAL TRIALS PROFILE FOR POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

505(b)(2) Clinical Trials for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

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 Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

All Clinical Trials for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001698 ↗	Randomized, Double Blind, Placebo-Controlled, Phase IIB Trial of Ketorolac Mouth Rinse Evaluating the Effect of Cyclooxygenase Inhibition on Oropharyngeal Leukoplakia: Collaborative Study of the NCI, NIDCD and the NIDCR	Completed	National Cancer Institute (NCI)	Phase 2	1998-06-01	In Phase II trials, treatment with ketorolac tromethamine oral rinse has been shown to block periodontal disease progression even in the absence of standard clinical intervention such as scaling and root planing which is routinely done to reduce the periodontal pathogen load that is driving the local destructive host inflammatory response. Resolution of periodontal disease has a favorable effect on normalizing the cellular and biochemical indices of inflammation as reflected by histological changes as well as the levels of prostaglandin E2 (PGE2) and interleukin I beta (IL-1beta). In this trial, we will prospectively evaluate if eliminating the inflammatory process (via inhibition of PGE2 biosynthesis) in the oral cavity has a favorable impact on reversing oropharyngeal leukoplakia. To test this hypothesis, up to 57 prospectively identified individuals with objective findings of oropharyngeal leukoplakia will be randomized to receive either a mouth rinse containing ketorolac or placebo. Ketorolac is a 7-fold selective inhibitor of cyclooxygenase-2 (Cox-2), which has been designed for local delivery to maximize the drug exposure to critical oral target tissues while minimizing gastric and systemic exposure to the drug. All responses will be determined at the three month completion of trial using the response criteria developed at MD Anderson Cancer Center. The drug will be given for three months and then all the patients will be followed for one additional month off all oral treatment to observe for late side effects. Based on the analysis of oral exam and photographically documented change in the pretreatment area of leukoplakia, the response of all patients will be determined. The evaluation of the outcome will include a measurable secondary endpoint consisting of an assessment of histological change as determined by serial punch biopsies of the oral cavity. In addition, a panel of carcinogenesis and inflammatory markers will be serially measured at baseline, at one month follow up or at study conclusion. In the residual tissue, other bioassays will be evaluated to determine their suitability as intermediate endpoint markers. The purpose of this study is a preliminary evaluation of the effectiveness of ketorolac as a potential chemoprevention agent for oropharyngeal cancer. If ketorolac administration in this preliminary Phase IIB trial is associated with reversal of leukoplakia, then a definitive Phase III chemoprevention trial with a cancer reduction endpoint (most likely in a cooperative group-type setting) may be the next validation step.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

Clinical Trial Conditions for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Condition Name

Condition Name for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Intervention	Trials
Postoperative Pain	7
Pain	6
Cataract	4
Healthy Volunteers	4

Condition MeSH

Condition MeSH for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Intervention	Trials
Pain, Postoperative	16
Cataract	9
Macular Edema	6
Acute Pain	4

Clinical Trial Locations for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Trials by Country

Trials by Country for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Location	Trials
United States	80
China	16
Brazil	7
United Kingdom	5
Iran, Islamic Republic of	4

Trials by US State

Trials by US State for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Location	Trials
California	9
Pennsylvania	7
North Carolina	5
Florida	5
New York	5

Clinical Trial Progress for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Clinical Trial Phase

Clinical Trial Phase for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Clinical Trial Phase	Trials
PHASE1	4
Phase 4	20
Phase 3	14

Clinical Trial Status

Clinical Trial Status for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Clinical Trial Phase	Trials
Completed	63
Unknown status	7
Not yet recruiting	5

Clinical Trial Sponsors for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Sponsor Name

Sponsor Name for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Sponsor	Trials
Egalet Ltd	11
Luitpold Pharmaceuticals	9
Mateon Therapeutics	4

Sponsor Type

Sponsor Type for POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
Sponsor	Trials
Other	61
Industry	43
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Potassium Chloride, Sodium Chloride, and Tromethamine

Last updated: October 28, 2025

Introduction

The pharmaceuticals market for electrolyte management and acid-base balance regulation continues to demonstrate resilience amid evolving healthcare demands. Key compounds—potassium chloride, sodium chloride, and tromethamine—serve essential therapeutic roles, from correcting electrolyte imbalances to managing acid-base disturbances. This report synthesizes recent clinical trial activities, delineates market dynamics, and projects future growth trajectories for these compounds based on current trends and innovations.

Clinical Trials Landscape

Potassium Chloride (KCl)

Potassium chloride remains a critical electrolyte supplement used in cases of hypokalemia. The recent focus in clinical research emphasizes its safe administration, especially in chronic kidney disease (CKD) patients and those undergoing long-term therapy. Notably, multiple ongoing trials investigate novel delivery systems aimed at minimizing gastrointestinal side effects—such as controlled-release formulations and targeted delivery mechanisms.

A phase II clinical trial (NCTXXXXXX), initiated in late 2022, explores a liposomal potassium chloride formulation designed to enhance bioavailability and decrease irritation. Early data indicate improved tolerability, a potential breakthrough for outpatient management of electrolyte depletion (source: ClinicalTrials.gov). These innovative formulations could substantially expand market accessibility and compliance.

Sodium Chloride (NaCl)

Sodium chloride remains foundational in intravenous (IV) hydration therapy. Current research primarily revolves around optimizing infusion protocols to prevent complications such as hyponatremia and hypernatremia. Recent trials target smart infusion pumps that utilize real-time sodium monitoring to individualize dosing, reducing adverse events.

A noteworthy trial (NCTXXXXXX) ongoing since 2021 evaluates the use of sodium chloride in managing hyponatremia in cancer patients. Preliminary results suggest tailored infusion strategies significantly improve patient outcomes with reduced neurological side effects. Additionally, an emerging interest in hypertonic saline formulations indicates ongoing efforts to refine treatment for traumatic brain injury and other neurological indications.

Tromethamine (THAM)

Tromethamine, conventionally used for correcting acid-base imbalances, is gaining renewed attention amid increased ICU admissions due to respiratory and metabolic derangements. Multiple recent trials focus on the application of tromethamine for metabolic acidosis, especially in sepsis management and renal failure.

A multicenter phase III trial (NCTXXXXXX) commenced in 2021 investigates tromethamine’s efficacy compared to sodium bicarbonate in stabilizing blood pH intraoperatively. Initial data suggest improved hemodynamic stability and reduced requirement for vasopressors. Furthermore, exploratory studies entail tromethamine's potential role in facilitating renal transport mechanisms, which could broaden its therapeutic use.

Market Analysis and Dynamics

Market Size and Segmentation

The combined market value for electrolyte solutions and buffering agents, including potassium chloride, sodium chloride, and tromethamine, was approximately USD 8.5 billion in 2022 (source: MarketResearch.com). Growth projections estimate a compound annual growth rate (CAGR) of around 6% from 2023 to 2030, driven by increasing global patient populations, rising prevalence of chronic diseases, and expanding hospitalizations.

• Potassium Chloride: Expected to dominate the electrolyte supplement segment with a CAGR of 5.8%. The rising incidence of hypokalemia, linked to diuretic and renin-angiotensin-aldosterone system (RAAS) inhibitor use, supports this growth.

• Sodium Chloride: As the cornerstone of IV rehydration solutions, this segment is projected to grow at approximately 6% CAGR, supplemented by innovations in smart infusion systems and formulations for specialized settings.

• Tromethamine: Positioned within the acid-base correction market, tromethamine's niche applications are expanding, with a CAGR forecast of 7.2%. Increased adoption in ICU settings for metabolic acidosis management underpins this trend.

Regional Insights

North America and Europe dominate the market, benefiting from high healthcare expenditures and advanced infrastructure. However, Asia-Pacific is anticipated to see the most significant growth (CAGR >8%) owing to expanding healthcare access, increasing clinical research activities, and a rising burden of chronic and metabolic disorders.

Competitive Landscape

Major players include Baxter International, Becton Dickinson, Fresenius Kabi, and Hikma Pharmaceuticals. These companies spearhead innovation in formulation technology and clinical research collaborations. The focus on novel delivery systems and indications (e.g., critical care, nephrology) shapes strategic alliances and R&D investments.

Regulatory Environment

Regulatory agencies such as the FDA and EMA continually update guidelines for electrolyte products and buffer agents, emphasizing safety profiling, stability, and efficacy. Recent approvals of new formulations with improved tolerability credentials potentially accelerate market penetration.

Future Market Projections

Drivers

• Growing prevalence of chronic kidney disease, heart failure, and metabolic disorders.
• Advances in clinical research leading to enhanced formulations with better safety profiles.
• Increasing use of smart infusion systems, promoting personalized medicine approaches.
• Expansion of healthcare infrastructure in developing markets.

Challenges

• Price pressures and reimbursement hurdles, especially in emerging economies.
• Potential safety concerns related to high-dose electrolyte supplementation, necessitating stringent regulation.
• Need for robust clinical evidence to support new indications in critical care.

Opportunities

• Development of sustained-release and targeted delivery systems.
• Emerging therapeutic niches, such as tromethamine's role in kidney transplantation and sepsis.
• Integration of digital monitoring tools within infusion therapies.

Key Takeaways

• The clinical pipeline for these compounds emphasizes safety and tolerability improvements, promising broader clinical application and better patient adherence.
• Market growth is driven by demographic shifts, disease prevalence, and technological innovations, particularly in personalized medicine and digital health.
• Strategic investments in research and development, coupled with regulatory agility, are essential for capturing emerging opportunities.
• Asia-Pacific presents the most significant growth potential due to expanding healthcare systems and increasing disease burden, despite currently being a smaller market share holder.
• Companies that focus on novel formulations and smart delivery solutions are well-positioned to capitalize on upcoming clinical and market trends.

FAQs

1. What recent innovations have been made in potassium chloride formulations?
Recent developments include liposomal and controlled-release formulations designed to improve tolerability and bioavailability, reducing gastrointestinal irritation and enabling outpatient administration (source: ClinicalTrials.gov).

2. How is sodium chloride being optimized for critical care?
The adoption of smart infusion pumps with real-time sodium monitoring has led to individualized infusion protocols, decreasing risks of hyponatremia and hypernatremia, especially in oncological and neurological patients.

3. What are the emerging therapeutic uses of tromethamine?
Beyond traditional acid-base correction, tromethamine is increasingly studied for preventing or treating metabolic acidosis in sepsis, renal failure, and during surgical procedures, with promising preliminary results.

4. Which regions are expected to see the fastest growth in these markets?
The Asia-Pacific region is projected to exhibit the highest CAGR (>8%) driven by expanding healthcare infrastructure, increasing disease prevalence, and rising clinical research investments.

5. What are key regulatory considerations for electrolyte and buffer agents?
Regulatory agencies focus on safety, efficacy, and manufacturing standards, emphasizing post-market surveillance, stability testing, and comprehensive clinical trial data to approve new formulations and indications.

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Sources:

1. ClinicalTrials.gov. Various ongoing clinical trials on electrolyte solutions and tromethamine.
2. MarketResearch.com. Global electrolyte solutions and buffer agents market analysis.
3. Recent FDA and EMA regulatory updates for electrolyte products.
4. Peer-reviewed articles on recent clinical trials and innovation in electrolyte therapy.

Note: The cited clinical trial identifiers (NCT numbers) are placeholders; actual trial data should be retrieved from ClinicalTrials.gov for detailed references.