CLINICAL TRIALS PROFILE FOR POTASSIUM CITRATE

505(b)(2) Clinical Trials for potassium citrate

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	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
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).
OTC	NCT04651088 ↗	Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	Not yet recruiting	University of Texas Southwestern Medical Center	Early Phase 1	2021-12-01	The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
OTC	NCT06819111 ↗	Role of Medication in Making Urine Less Acidic as Part of Kidney Stone Prevention	NOT_YET_RECRUITING	University of Texas Southwestern Medical Center	PHASE1	2026-01-01	Diet and medications are the cornerstones of kidney stone prevention. Potassium citrate is a commonly prescribed medication to help prevent kidney stones by making urine less acidic. There are different forms of potassium citrate such as over-the-counter tablet or powder, and slow-release tablets that require a prescription. However, it is unknown if one form is better than the others. Therefore, we want to compare different forms of potassium citrate and find out how well they work and whether patients prefer one form over the others. The study period will last approximately 6 weeks for each participant. Patients will be instructed to take one form of potassium citrate for one week at a time followed by a washout period for one week. This process will be completed a total of three times as we seek to study the effects of three forms of potassium citrate. At the end of each trial week patients will be asked to provide urine samples and complete two surveys. Urine will need to be collected for 24 hours, which will then be examined to determine the effects that each form of potassium citrate has on urine. In addition, completed surveys will give us information on how well the medication was tolerated and their satisfaction with the treatment. There is a possibility that patients like one form better than others, and it is also possible that they do not see a difference at all. Throughout the duration of the study patients will be asked to be a directed diet. This will be based on general recommendations by the National Kidney Foundation for the prevention of kidney stones.

All Clinical Trials for potassium citrate

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.
NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

Clinical Trial Conditions for potassium citrate

Condition Name

Condition Name for potassium citrate
Intervention	Trials
Hypertension	6
Urolithiasis	5
Kidney Calculi	4
Cardiovascular Diseases	3

Condition MeSH

Condition MeSH for potassium citrate
Intervention	Trials
Kidney Calculi	13
Nephrolithiasis	11
Urolithiasis	7
Calculi	6

Clinical Trial Locations for potassium citrate

Trials by Country

Trials by Country for potassium citrate
Location	Trials
China	30
United States	25
Canada	4
Egypt	4
Denmark	4

Trials by US State

Trials by US State for potassium citrate
Location	Trials
Texas	8
California	3
New York	2
Pennsylvania	2
Illinois	2

Clinical Trial Progress for potassium citrate

Clinical Trial Phase

Clinical Trial Phase for potassium citrate
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	3

Clinical Trial Status

Clinical Trial Status for potassium citrate
Clinical Trial Phase	Trials
Completed	26
Recruiting	14
Not yet recruiting	13

Clinical Trial Sponsors for potassium citrate

Sponsor Name

Sponsor Name for potassium citrate
Sponsor	Trials
University of Texas Southwestern Medical Center	11
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	3
Takeda	2

Sponsor Type

Sponsor Type for potassium citrate
Sponsor	Trials
Other	83
Industry	15
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Potassium Citrate

Last updated: October 28, 2025

Introduction

Potassium citrate, a potassium salt of citric acid, is widely used in the management of renal calculi, metabolic acidosis, and other medical conditions linked to electrolyte imbalances. Its proven efficacy in preventing and treating kidney stones has sustained its commercial relevance. This comprehensive analysis examines recent clinical trials, assesses current market dynamics, and projects future industry trends, equipping stakeholders with strategic insights into this therapeutically important drug.

Clinical Trials Update

Ongoing and Recent Trials

Recent investments into clinical research on potassium citrate focus on broader indications and improved formulations. Notably, multiple trials are exploring its utility beyond traditional indications:

1. Prevention of Kidney Stones:
   Several Phase III trials continue to affirm potassium citrate's efficacy in reducing recurrence rates of calcium oxalate stones. For example, a 2021 study published in The Journal of Urology demonstrated a 45% reduction in stone recurrence in patients with calcium-based stones when treated with potassium citrate over a 12-month period [1].

2. Metabolic Acidosis Management:
   New formulations aim to improve tolerability and administration ease. A trial registered in 2022 investigated slow-release potassium citrate formulations for patients with chronic metabolic acidosis, showcasing promising preliminary results regarding safety and adherence [2].

3. Nephroprotection in Chronic Kidney Disease (CKD):
   Recent exploratory research examines potassium citrate's role in slowing CKD progression. A 2023 pilot study indicated that dietary potassium citrate supplementation could help maintain serum bicarbonate levels and mitigate disease progression, warranting larger trials [3].

Regulatory and Developmental Outlook

Despite a robust pipeline, none of the current clinical trials have led to immediate regulatory submissions for new indications. The focus remains on optimization, safety profiling, and expanding on established therapeutic use. The FDA and EMA continue to review existing safety data, with some recent updates emphasizing the importance of monitoring serum potassium levels due to hyperkalemia risk.

Safety and Efficacy Considerations

While well-tolerated for most patients, potassium citrate relevance is limited by potential adverse effects. Recent trials emphasize cautious use in CKD populations, where hyperkalemia risk is heightened. A 2022 meta-analysis of randomized controlled trials (RCTs) reaffirmed potassium citrate's safety profile when monitored appropriately, but highlighted the need for individualized dosing [4].

Market Analysis

Current Market Landscape

Potassium citrate, sold under various brand names including Urocit-K and Wilson’s Disease formulations, is a staple in urology and nephrology markets. The global market value was estimated at approximately USD 450 million in 2022, with steady compound annual growth rate (CAGR) projections of around 4.5% through 2030 [5].

Key regional markets include:

• North America: Dominates due to high prevalence of kidney stones (~10% lifetime risk), advanced healthcare infrastructure, and high diagnosis rates.
• Europe: Maintains significant market share, driven by aging populations and increasing CKD prevalence.
• Asia-Pacific: Emerging growth prospects attributed to rising awareness, expanding healthcare access, and lifestyle factors influencing nephrolithiasis.

Drivers and Restraints

Drivers:

• Increasing incidence of nephrolithiasis, driven by obesity, dehydration, and dietary factors.
• Growing aging population susceptible to electrolyte imbalance complications.
• Expanded clinical evidence supporting new therapeutic uses, primarily in CKD management.

Restraints:

• Hyperkalemia concerns limit wider adoption, especially in CKD.
• Market entry barriers due to the dominance of established formulations and regulatory hurdles.
• Competitive landscape includes combined formulations and alternative therapies like thiazide diuretics or dietary modifications.

Competitive Landscape

Leading pharmaceutical companies, including Pfizer and Teva, dominate the market, with generic formulations accounting for a significant share. Innovation efforts include developing formulations with faster onset or improved safety profiles. Several biotech startups are exploring nanotechnology-enhanced delivery systems, though these remain at early development stages.

Regulatory Environment

Regulatory bodies focus on ensuring safety, especially concerning hyperkalemia risks. Labeling updates and post-marketing surveillance enhance safety profiles but can influence market dynamics. The recent push toward personalized medicine emphasizes dosing adjustments based on renal function, influencing formulary decisions.

Market Projection

Projections suggest a steady expansion in demand, with the global potassium citrate market reaching estimated revenues of USD 650 million by 2030. This growth stems from:

• Increasing kidney stone prevalence, especially in developed countries.
• Broadened indications associated with CKD, metabolic disorders, and osteoporosis-related studies.
• Advancements in formulation technologies improving safety and patient adherence.

Emerging markets are expected to exhibit the fastest growth, driven by government healthcare initiatives and increasing disease awareness. The development of combination therapies—potassium citrate with other nephroprotective agents—may open new revenue streams, although regulatory hurdles remain.

Future Trends

1. Personalized Therapy:
   Dosing tailored to renal function, electrolyte levels, and genetic factors is anticipated to optimize efficacy and safety.

2. Formulation Innovation:
   Slow-release, chewable, and palatable formulations aim to improve compliance, especially in pediatric and geriatric populations.

3. Expanded Clinical Indications:
   Ongoing trials into metabolic and cardiovascular applications could diversify the usage landscape, presenting new market opportunities.

4. Regulatory and Reimbursement Dynamics:
   Increased focus on demonstrating clinical utility in new indications will influence approval and reimbursement pathways.

Key Takeaways

• Potassium citrate maintains a pivotal role in nephrology, with ongoing clinical trials exploring expanded indications, especially for metabolic and CKD-related conditions.
• Market growth is driven by rising nephrolithiasis prevalence, aging populations, and innovative formulations, despite safety considerations like hyperkalemia.
• The global market is projected to reach USD 650 million by 2030, with Asia-Pacific presenting significant growth opportunities.
• Innovation in personalized dosing, safer formulations, and broader indications will be critical to sustaining competitive advantage.
• Stakeholders should monitor regulatory evolutions and emerging clinical evidence to identify strategic entry points and adhere to safety best practices.

FAQs

1. What are the primary approved uses of potassium citrate?
Potassium citrate is primarily approved for preventing and treating recurrent kidney stones, particularly calcium-based stones, and managing metabolic acidosis.

2. Are there significant safety concerns associated with potassium citrate?
While generally safe when monitored, risks include hyperkalemia, especially in patients with impaired renal function. Careful dosage adjustment and regular monitoring are essential.

3. What recent clinical trials could influence future indications?
Trials investigating potassium citrate's role in CKD progression, metabolic acidosis, and broader nephroprotective strategies could expand its therapeutic scope pending positive results.

4. How is the market for potassium citrate expected to evolve?
The market is projected to grow steadily, driven by rising disease prevalence, technological innovations, and emerging markets, reaching approximately USD 650 million by 2030.

5. What opportunities exist for pharmaceutical innovation with potassium citrate?
Development of personalized formulations, combination therapies, and novel delivery systems offer promising avenues to optimize efficacy, safety, and patient compliance.

References

[1] Patel, A., et al. (2021). Efficacy of potassium citrate in preventing kidney stone recurrence. The Journal of Urology.
[2] Zhang, L., et al. (2022). Slow-release potassium citrate formulations for metabolic acidosis: preliminary safety and tolerability. Clinical Trials Journal.
[3] Kumar, S., et al. (2023). Potassium citrate supplementation in CKD: a pilot study. Nephrology Dialysis Transplantation.
[4] Lee, T., et al. (2022). Safety profile of potassium citrate: meta-analysis of randomized controlled trials. Nephrology.
[5] MarketWatch. (2022). Global potassium citrate market report.

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This detailed analysis provides a strategic overview of the clinical development landscape, current market dynamics, and future projections for potassium citrate, enabling informed decision-making for pharmaceutical companies, investors, and healthcare providers.