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.
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.
NCT00357331 ↗	The Effects of Potassium Citrate on Bone Metabolism	Completed	Weill Medical College of Cornell University	Phase 4	2006-08-01	Skeletal buffering of chronic acid loads may contribute to a significant amount of bone loss over time. Evidence from a few small short-term studies suggests that basic compounds, namely potassium citrate and potassium bicarbonate may reduce bone loss and improve bone density. The purpose of this study is to evaluate the effects of potassium citrate on bone metabolism. We hypothesize that administration of potassium citrate to postmenopausal women with osteopenia will reduce bone resorption and improve bone mineral density. Postmenopausal women with osteopenia (T score between -1.0 and -2.5) and no history of fracture will be randomized to either daily potassium citrate or placebo for one year. Primary outcomes will be markers of bone turnover, which will be measured over 12 months. Secondary outcomes will be bone mineral density, compliance, and adverse events.

Clinical Trial Conditions for POTASSIUM CITRATE

Condition Name

Condition Name for POTASSIUM CITRATE
Intervention	Trials
Hypertension	6
Urolithiasis	5
Kidney Calculi	4
Kidney Stone	3

Condition MeSH

Condition MeSH for POTASSIUM CITRATE
Intervention	Trials
Kidney Calculi	13
Nephrolithiasis	11
Urolithiasis	7
Hypertension	6

Clinical Trial Locations for POTASSIUM CITRATE

Trials by Country

Trials by Country for POTASSIUM CITRATE
Location	Trials
China	31
United States	25
Denmark	4
Canada	4
Egypt	4

Trials by US State

Trials by US State for POTASSIUM CITRATE
Location	Trials
Texas	8
California	3
Pennsylvania	2
Illinois	2
New York	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	4

Clinical Trial Status

Clinical Trial Status for POTASSIUM CITRATE
Clinical Trial Phase	Trials
Completed	26
RECRUITING	15
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
Mansoura University	2

Sponsor Type

Sponsor Type for POTASSIUM CITRATE
Sponsor	Trials
Other	83
Industry	16
NIH	6

POTASSIUM CITRATE Market Analysis and Financial Projection

Last updated: April 26, 2026

Potassium Citrate Clinical Trials Update and Market Outlook (2026)

What is the current clinical-trials landscape for potassium citrate?

Potassium citrate is a long-established oral alkalinizing agent used primarily to prevent and manage calcium-based kidney stones and to treat metabolic conditions associated with low citrate and/or acidosis. Public clinical-trial activity is sparse because potassium citrate is widely marketed as an established generic and non-proprietary therapy in most jurisdictions, which reduces sponsor incentives for large, brand-led Phase 3 programs.

No complete, current “all-trials” snapshot can be produced from the information provided in this prompt alone.

What does the market look like for potassium citrate in 2026?

Potassium citrate has two main demand drivers:

• Kidney-stone prevention and recurrence reduction (especially calcium stones) via urine alkalinization and citrate supplementation.
• Metabolic acidosis or hypocitraturia-related indications in clinical practice, depending on local labeling and guideline alignment.

The market is structurally characterized by:

• High generic penetration in most developed markets.
• Price competition across tablet, effervescent, and extended-release formats.
• Fragmented channel mix: hospital urology and nephrology prescribing plus outpatient primary care and nephrology.

No complete, current market sizing and forecast can be produced from the information provided in this prompt alone.

What product and formulation factors move demand?

For potassium citrate, formulation and patient adherence affect real-world utilization:

• Dose flexibility and pill burden (smaller tablets vs larger extended-release tablets)
• Effervescent formulations (improved tolerability for some patients)
• Titration protocols based on urine pH and urinary citrate targets in nephrolithiasis management

In markets with tight formularies, cost per daily dose is often the decisive factor, which favors lower-priced generics unless a product has a clear adherence or tolerability advantage.

What is the near-term outlook for uptake and competitive dynamics?

Near-term trajectory is driven by:

• Guideline-driven recurrence prevention in calcium nephrolithiasis.
• Older demographics in key markets, which tend to increase incidence and recurrence.
• Generic substitution and payer protocols that keep unit prices compressed.

Key risks:

• Clinical practice variability in how strongly citrate therapy is adopted across stone types and risk profiles.
• Safety and tolerability constraints in patients with impaired renal function or hyperkalemia risk.
• Adherence barriers from multi-daily dosing regimens.

How should investors and R&D planners model demand and growth?

Because potassium citrate is largely mature and generic, demand modeling should be built around:

• Total treated patient counts (rather than brand penetration).
• Adherence and dosing regimen mix by formulation type.
• Payer coverage durability for alkalinizing agents.
• Regional nephrolithiasis treatment trends (imaging and recurrence management intensity).

A credible projection must segment by:

• Indication (kidney stone prevention vs metabolic indications)
• Geography (policy and reimbursement patterns)
• Form factor (tablet vs effervescent vs extended-release)
• Payer tiering (preferred generic status)

A complete projection cannot be generated from the information provided in this prompt alone.

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Clinical Trials Update: What should be monitored next?

Trial types typically relevant to potassium citrate

In a mature, generic molecule, any meaningful new clinical evidence usually falls into narrow categories:

• Comparative effectiveness studies of different potassium citrate formulations
• Dose-ranging and adherence studies (tolerability, urine pH targets, urinary citrate response)
• Subgroup analyses tied to stone recurrence risk and renal function
• Real-world evidence studies that quantify persistence and discontinuation drivers

Monitoring signals with business value

Track:

• Protocol postings and active recruitment in nephrolithiasis cohorts
• Endpoints focused on urinary citrate, urine pH, and recurrence proxies
• Safety reporting focused on hyperkalemia and renal impairment

A full “current status” list of trials cannot be produced from the information provided in this prompt alone.

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Market Analysis and Projection: How is growth likely to behave?

Demand mechanics

Potassium citrate demand is mostly “volume” rather than “price” in mature markets due to generic competition. The growth profile usually tracks:

• Nephrolithiasis incidence and recurrence management practices
• Persistence of long-term prophylaxis
• Expanded use in patients at higher recurrence risk under guideline-based care

Competitive landscape

Competition mainly comes from:

• Multiple generic manufacturers
• Formulation-specific substitution
• Alternative alkalinizing regimens used in some settings

Market share is typically won on:

• Net price after payer rebates
• Formulation preference under formulary rules
• Availability and stability supply

2026 projection framework (what can be modeled without proprietary data)

A robust projection should use:

• Scenario bands anchored to expected treated population growth
• Assumption sets for persistence and discontinuation
• Unit price decline assumptions driven by generic dynamics

A numeric forecast cannot be produced from the information provided in this prompt alone.

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Key Takeaways

• Potassium citrate is a mature, widely genericized therapy with demand anchored in kidney-stone prevention and urine chemistry targets.
• Clinical-trial activity is typically limited to formulation, dosing, adherence, and real-world evidence rather than large brand-led Phase 3 programs.
• Market growth is likely constrained by generic competition, with emphasis on volume, payer formularies, and formulation-led adherence.
• Any actionable 2026 forecast needs current public trial and market data that are not present in the prompt.

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FAQs

1. What are the primary clinical use cases for potassium citrate?
   Kidney-stone prevention (especially calcium stones) and correction of hypocitraturia/metabolic conditions where urine alkalinization is indicated.

2. Is there meaningful brand differentiation for potassium citrate?
   Differentiation exists mainly through formulation, dosing convenience, and tolerability, but competitive dynamics are dominated by generics.

3. What endpoints matter most if new trials appear?
   Urinary citrate response, urine pH targets, recurrence proxies, persistence/adherence, and hyperkalemia/renal safety.

4. What drives payer decisions for potassium citrate?
   Net cost per daily dose, preferred formulary status, and patient adherence considerations tied to formulation.

5. Where is upside most likely to come from in 2026?
   Increased treated population and improved persistence through formulation and adherence, not major price expansion.

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References

[1] No external sources were provided in the prompt, and no additional sources can be cited without them.