CLINICAL TRIALS PROFILE FOR UROCIT-K

505(b)(2) Clinical Trials for UROCIT-K

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
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 UROCIT-K

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT06335537 ↗	Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers	RECRUITING	University of California, Irvine	PHASE1	2025-05-01	The incidence of kidney stone disease continues to rise globally. Although the treatment of kidney stone disease has dramatically improved in recent years, surgical management remains invasive and expensive. Patients who develop kidney stones are at high risk of recurrence during their lifetime; therefore, prevention of stones should be a primary focus. Low levels of citrate and acidic urine are risk factors for the formation of kidney stones such as calcium oxalate and uric acid, respectively. Calcium oxalate stones are the predominant stone composition in the United States, accounting for over 2/3rds of stones. Citrate is a key inhibitor of calcium oxalate crystal formation and thus increasing it in the urine of a calcium oxalate stone former is quite beneficial. Uric acid stones account for approximately 10 percent of all stone types. These stones form primarily due to an acidic urinary environment which is a prerequisite for crystal formation. Common medications for stone formers include potassium citrate which help to make the urine more alkaline. Although effective, these medications have side effects and may prove to be too expensive (upwards of $450/month). Consuming baking soda (sodium bicarbonate) may prove to be an inexpensive ($0.34/month) equally effective alternative with respect to increasing urinary citrate levels and alkalinizing the urine. Investigators hypothesize that twice a day oral baking soda in a liquid medium (e.g., water, orange juice, soda, etc.) can be an effective, and inexpensive alternative to urocit K with regard to alkalinizing the urine and raising urinary citrate levels.
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.

Clinical Trial Conditions for UROCIT-K

Condition Name

Condition Name for UROCIT-K
Intervention	Trials
Kidney Calculi	1
Kidney Stone	1
Uric Acid Stones	1

Condition MeSH

Condition MeSH for UROCIT-K
Intervention	Trials
Kidney Calculi	2

Clinical Trial Locations for UROCIT-K

Trials by Country

Trials by Country for UROCIT-K
Location	Trials
United States	1

Trials by US State

Trials by US State for UROCIT-K
Location	Trials
California	1

Clinical Trial Progress for UROCIT-K

Clinical Trial Phase

Clinical Trial Phase for UROCIT-K
Clinical Trial Phase	Trials
PHASE1	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for UROCIT-K
Clinical Trial Phase	Trials
Not yet recruiting	1
NOT_YET_RECRUITING	1
RECRUITING	1

Clinical Trial Sponsors for UROCIT-K

Sponsor Name

Sponsor Name for UROCIT-K
Sponsor	Trials
University of Texas Southwestern Medical Center	2
University of California, Irvine	1

Sponsor Type

Sponsor Type for UROCIT-K
Sponsor	Trials
Other	3

UROCIT-K Market Analysis and Financial Projection

Last updated: May 1, 2026

UROCIT-K (potassium citrate): clinical trials update, market analysis, and projection

What is UROCIT-K and how is it positioned clinically?

UROCIT-K is a potassium citrate drug used to increase urinary citrate and alkalinize urine to reduce risk of certain types of kidney stones. In practice, it is prescribed most often for uric acid stone prevention and for conditions involving low urinary citrate (hypocitraturia). The product is widely characterized as a long-established, off-patent branded medicine competing with generics and multiple citrate formulations.

Clinical-development reality: UROCIT-K is not a platform for new registrational evidence in the way modern pipeline assets operate. Commercial updates typically come through:

• label maintenance,
• generic interchangeability and market access changes,
• formulation and supply continuity events,
• payer coverage shifts tied to step therapy and cost.

Because this is a legacy product, “clinical trials update” in the strict sense usually means verifying whether any new pivotal trials are underway that would materially change the label or indicate expanded indications.

Is there meaningful new clinical trial readout activity that changes the UROCIT-K label?

No. There is no evidence-based basis to claim that UROCIT-K is currently generating new pivotal-phase clinical readouts that would modify its core approved use or expand indications in a way comparable to a new molecular entity.

Implication for R&D and investment: UROCIT-K should be treated as a commercial product with incremental evidence needs (label maintenance, post-marketing surveillance, and bioavailability-related documentation for generics), not as an actively developing clinical program.

What does the competitive landscape look like for potassium citrate?

UROCIT-K competes in a class with:

• generic potassium citrate tablets and liquids,
• other potassium citrate brands,
• alternative stone-prevention regimens that target urine chemistry (e.g., other alkalinization approaches).

Competitive pressure is driven by:

• WAC/AWP-to-net price erosion typical for long-established products,
• formulary placement based on cost and prior authorization rules,
• patient adherence considerations (dose frequency and pill burden),
• availability and manufacturing continuity.

Where does demand come from in the kidney stone market?

Demand correlates with:

• prevalence of nephrolithiasis in the adult population,
• recurrence risk after first stone episode,
• clinician practice patterns for urine chemistry modification.

Key clinical demand drivers:

• high recurrence rates for kidney stones,
• increasing outpatient management and imaging that identifies stone risk,
• rising rates of metabolic factors that contribute to stones (dietary patterns, obesity correlations, dehydration patterns).

How does payer behavior affect UROCIT-K economics?

For legacy stone-prevention drugs, payer policies commonly steer patients toward:

• least-cost generics,
• preferred brand if there is a contracted value,
• step therapy when multiple formulary options exist.

That dynamic compresses margin potential and shifts commercial value toward:

• pharmacy benefit execution,
• contracting strategy,
• channel management.

How big is the potassium citrate addressable market?

Potassium citrate sits inside a broader nephrolithiasis supportive-care market. The addressable population is not “all stone formers,” but those for whom clinicians target urine chemistry with citrate/alkalinization rather than other interventions.

A practical market segmentation framework used in commercial models:

• patients with uric acid stones or uric acid physiology who benefit from alkalinization,
• patients with hypocitraturia and recurrent risk who need citrate supplementation,
• patients transitioning to citrate therapy after recurrence.

Market share: what determines brand vs generic outcomes?

UROCIT-K brand share is primarily determined by:

• formulary access (commercial and government plans),
• generic substitution rates,
• contract terms,
• patient out-of-pocket cost differentials.

In most mature markets, branded share persists only if:

• generics are constrained at the pharmacy level,
• the brand has contracted preferred status,
• specific dosing forms are favored.

Market projection: what trajectory is realistic?

Given typical dynamics for mature, off-patent legacy brands:

• unit demand generally tracks nephrolithiasis recurrence prevalence and adherence,
• revenue growth is capped by generic substitution and price compression,
• growth upside comes from market expansion via better guideline adherence or increased diagnosis, not from label expansion.

Projection framing for UROCIT-K:

• Base case: modest volume stability or low single-digit growth with continued pricing pressure from generics.
• Downside case: accelerated net price erosion from formulary switches and higher substitution.
• Upside case: temporary supply constraints on competitors or a favorable contracting environment that preserves branded net revenue.

What is the most actionable commercial outlook for the next 3 to 5 years?

1. Net revenue is the primary variable, not demand.
   • With generics, branded revenue depends on net pricing after rebates and contracting.
2. Formulary execution is the primary lever.
   • Small changes in payer status move share quickly in mature categories.
3. Clinical differentiation is limited.
   • UROCIT-K and generics treat the same physiology; differentiation hinges on access and patient tolerability (pill burden, formulation).

Operational checklist: what to monitor for UROCIT-K in 2026+

• Pharmacy benefit trend reports for citrate therapies (preferred list changes).
• Competitive generic launches or supply interruptions for potassium citrate.
• Evidence of payer tightening for non-preferred brand coverage.
• Any regulatory label maintenance announcements for citrate indications.
• Claims data shifts: recurrence management patterns and adherence persistence.

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Key Takeaways

• UROCIT-K is a legacy potassium citrate product with established clinical use in kidney stone prevention via urine chemistry modification.
• There is no evidence basis for meaningful new pivotal clinical trial activity that would change its core label in a way that materially shifts the product’s R&D posture.
• Market outcomes are dominated by generic substitution, net price erosion, and formulary placement rather than novel clinical differentiation.
• Near-term projections favor stability with modest volume movement and continued pressure on branded revenue unless payer contracting or supply conditions improve.

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FAQs

1) Is UROCIT-K undergoing new phase 3 development that could expand indications?

No. The product behaves like a mature, off-patent medicine with no substantiated active registrational program driving label expansion.

2) What clinical conditions drive UROCIT-K prescribing most often?

UROCIT-K is used to alkalinize urine and increase urinary citrate, most commonly in prevention of kidney stones linked to uric acid physiology and hypocitraturia.

3) How does generic substitution typically affect UROCIT-K revenue?

Generic substitution usually compresses net pricing and brand share unless the branded product holds preferred status or competitor supply constraints emerge.

4) What payer levers matter most for UROCIT-K?

Formulary preference, step therapy, prior authorization, and contracted net pricing drive branded outcomes more than differences in clinical evidence.

5) What is the highest-probability market scenario over the next 3 to 5 years?

A base case of stable to modest volume with ongoing pricing pressure, resulting in flat-to-slightly growing revenue only if contracting offsets erosion.

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References

[1] FDA. (n.d.). Drug approvals and labeling resources for potassium citrate products (UROCIT-K label information). U.S. Food and Drug Administration.
[2] DailyMed. (n.d.). UROCIT-K (potassium citrate) prescribing information. U.S. National Library of Medicine.
[3] American Urological Association (AUA). (n.d.). Kidney stone guidelines relevant to urine chemistries and citrate/alkalinization strategies.