Last Updated: May 1, 2026

CLINICAL TRIALS PROFILE FOR SODIUM POLYSTYRENE SULFONATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Sodium Polystyrene Sulfonate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004328 ↗ Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I Completed University of Texas Phase 2 1992-12-01 OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004328 ↗ Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I Completed National Center for Research Resources (NCRR) Phase 2 1992-12-01 OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT01189344 ↗ Levothyroxine (L-T4) Absorption After Bariatric Surgery Completed University of Sao Paulo N/A 2007-09-01 Intestinal absorption of levothyroxine (LT4) tablets depends on its dissolution in gastric acid secretion, which is reduced after bariatric interventions. Impaired LT4 absorption due to low gastric dissolution has been reported in patients with atrophic or chronic gastritis. The objective of this study is to evaluate the absorption of LT4 tablets in morbidly obese patients before and after Roux-en-Y bariatric surgery.
NCT01866709 ↗ Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia Terminated ZS Pharma, Inc. Phase 4 2013-05-01 It is hypothesized that SPS is more effective than placebo control (alternative hypothesis) in lowering i-STAT potassium levels in subjects with i-STAT potassium levels between 5.0 - 6.5 mmol/l versus no difference between SPS and placebo control (null hypothesis).
NCT02065076 ↗ Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients Completed Department of Pharmacy, Maisonneuve Rosemont Hospital Phase 4 2014-02-01 The purpose of this trial is to determine if sodium polystyrene sulfonate (SPS) is an effective treatment of mild hyperkalemia in chronic kidney disease patients followed at a pre-dialysis or nephrology outpatient clinic. Subjects will be randomized to one of two treatment arms: 30 g of placebo or SPS to be taken orally once daily for seven days. The change in serum potassium levels will be compared in both treatment groups. The proportion of subjects attaining normokalemia (3.5 to 5.0 mmol/L) after seven days of treatment will also be compared. Finally, side effects will be reported for each treatment arm.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Polystyrene Sulfonate

Condition Name

Condition Name for Sodium Polystyrene Sulfonate
Intervention Trials
Hyperkalemia 4
Acute Hyperkalemia 1
Attention Deficit Hyperactivity Disorder 1
Chronic Kidney Disease Stage 3 and 4 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Sodium Polystyrene Sulfonate
Intervention Trials
Hyperkalemia 6
Attention Deficit Disorder with Hyperactivity 1
Renal Insufficiency 1
Kidney Failure, Chronic 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Sodium Polystyrene Sulfonate

Trials by Country

Trials by Country for Sodium Polystyrene Sulfonate
Location Trials
United States 4
Canada 1
Italy 1
Brazil 1
Egypt 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Sodium Polystyrene Sulfonate
Location Trials
Florida 2
California 1
New York 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Sodium Polystyrene Sulfonate

Clinical Trial Phase

Clinical Trial Phase for Sodium Polystyrene Sulfonate
Clinical Trial Phase Trials
PHASE3 1
Phase 4 5
Phase 2 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Sodium Polystyrene Sulfonate
Clinical Trial Phase Trials
Completed 6
RECRUITING 2
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Sodium Polystyrene Sulfonate

Sponsor Name

Sponsor Name for Sodium Polystyrene Sulfonate
Sponsor Trials
National Center for Research Resources (NCRR) 1
Alexandria University 1
University of Sao Paulo 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Sodium Polystyrene Sulfonate
Sponsor Trials
Other 11
Industry 2
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sodium Polystyrene Sulfonate (SPS): Clinical Trial Signals, Market Read, and Value Outlook

Last updated: April 25, 2026

What is sodium polystyrene sulfonate in the clinical landscape?

Sodium polystyrene sulfonate (SPS) is a potassium-binding cation-exchange resin used to treat hyperkalemia. The product is best understood as a high-volume, low-complexity generic medicine with entrenched clinical positioning in acute and chronic hyperkalemia management.

From a trial and development standpoint, SPS is not a modern “pipeline” drug. The clinical record largely reflects older prescribing experience and manufacturing normalization rather than new mechanism-driven development.

What clinical trial updates matter for SPS right now?

No complete, current, trial-level update set is available in the provided material to support a status call (recruiting, active, completed), endpoints (e.g., time to potassium normalization), or regulatory-relevant outcomes for specific new studies.

What can be stated from the available record is that SPS’s clinical utilization pattern and prescriber reliance sit in a mature segment where new entrants typically target formulation, dosing, tolerability, and speed-to-effect rather than proving a new binding mechanism. This is consistent with the FDA labeling history for the class and the long-standing use of resin binders in hyperkalemia.

Because a concrete “clinical trials update” requires verifiable trial identifiers, dates, and results, this report does not project incremental performance claims or timelines for SPS trials.

How does SPS compete in market context?

SPS faces competition across three axes: efficacy speed, tolerability, and setting of care (ED/inpatient vs ambulatory).

Market structure

  1. Resin binders (older class positioning)
    SPS and other resins have established use and supply chains. Their market share is constrained by speed-to-effect perceptions and gastrointestinal tolerability concerns that have shifted share toward newer agents.
  2. Newer potassium binders (share-inflow pressure)
    New potassium binders with different physicochemical behaviors and dosing regimens tend to capture new prescriptions, particularly where clinicians want predictable onset and improved GI tolerability.
  3. Renal disease and CKD hyperkalemia management programs
    SPS demand is tied to CKD and dialysis-related hyperkalemia prevalence, and to institutional formulary practices.

Pricing and substitution dynamics

SPS is a generic, so pricing is driven by:

  • Wholesale acquisition and contracted pricing in hospital and payer formularies
  • Dispensing economics (oral vs other forms, kit/bundle handling)
  • Institutional protocols that may favor specific binders by evidence tier and nursing workflow

This generally results in a slower rate of market expansion than branded or “new mechanism” binders, even when SPS remains clinically acceptable in practice.

What do the label and risk facts imply for commercial use?

SPS use is shaped by safety considerations that affect formulary acceptance and dosing protocols. Resin binders are associated with rare but serious GI adverse events, and label warnings typically influence clinician behavior.

The most defensible commercial implication is that SPS is managed through:

  • Institutional patient selection (risk stratification)
  • Dosing and administration protocol controls
  • Preference for alternative agents when a facility has standardized on newer binders

Practical implications for demand

  • Higher share in settings that already stock resins and have well-worn nursing protocols
  • Lower share where outcomes and tolerability metrics are prioritized and where newer agents are preferred

Where is SPS likely to grow or decline?

SPS’s market trajectory is driven by two opposing forces: hyperkalemia prevalence growth and binder substitution.

Growth tailwinds

  • Increasing CKD and cardiovascular comorbidity burden increases hyperkalemia incidence.
  • Dialysis-related hyperkalemia management sustains chronic binder demand.
  • SPS can remain a backstop option where formularies include multiple binders.

Decline or share erosion pressures

  • Institutional substitution toward newer agents.
  • GI tolerability and rare serious adverse event concerns shift new patient starts toward alternatives.
  • Competitive procurement: when payers and hospitals negotiate broader binder portfolios, SPS competes on cost and protocol fit.

Market projection framework (what can be projected with confidence from mature generics)?

A numerical projection requires a base year, market size, and a forecast methodology anchored in credible, cited sales data. No such sales dataset is present in the available input. Under the operating constraint, this report therefore does not provide market-size numbers or EPS-style financial forecasts.

Instead, this section provides a decision-grade projection structure used by institutional forecasters for mature, generics-heavy drug classes:

Value drivers and sensitivity levers

  • Formulary penetration rate (hospitals adopting resin-inclusive protocols)
  • Share within the binder basket (SPS mix vs newer binders)
  • Net price trend (contracting and tender dynamics)
  • Utilization intensity (ED/inpatient use vs chronic outpatient use)
  • Protocol adherence and administration constraints (impacts dosing and re-dosing frequency)

Expected directional outlook (non-numeric)

  • Net utilization likely grows with hyperkalemia prevalence, but
  • Relative share likely compresses versus newer binders in formularies prioritizing tolerability and speed-to-effect.

Regulatory and product strategy signals

SPS is historically regulated as a potassium-binding resin, and modern commercial differentiation in this space typically comes from:

  • Formulation improvements (handling, patient experience)
  • Packaging and administration protocols
  • Dose standardization within labeling constraints
  • Localization of supply and manufacturing

For SPS specifically, the near-term strategic posture is more about defending formulary placement and supply continuity than launching brand-new clinical programs.

Competitive positioning snapshot

SPS competes against two categories rather than one:

  • Older resins (direct class substitution)
  • Newer binders (indirect substitution driven by tolerability and workflow)

SPS wins when:

  • It is included in binder formularies as a lower-cost option
  • Hospital protocols allow flexible use
  • Patients are managed safely within GI risk mitigation protocols

SPS loses when:

  • Formularies standardize on newer binders as first-line
  • GI risk mitigation requires tighter controls that favor alternative binders
  • Competitive tender drives binder basket pricing

Key Takeaways

  • SPS is a mature potassium-binding resin used for hyperkalemia; it is not in an active, mechanism-driven development phase that supports a fresh “trial update” with verifiable endpoints and timelines.
  • Commercial performance is dominated by formulary inclusion, contracted pricing, and substitution versus newer potassium binders, not by new clinical trial breakthroughs.
  • Without cited sales datasets and specific trial identifiers, numeric market projections are not supported. Directionally, demand follows hyperkalemia prevalence, while SPS share faces pressure from newer binders that improve tolerability and workflow.
  • The strategic focus is formulary defense, protocol-aligned utilization, and supply continuity rather than new clinical differentiation.

FAQs

  1. Is sodium polystyrene sulfonate considered a new-generation hyperkalemia therapy?
    No. It is a mature resin binder used in hyperkalemia with an entrenched clinical and commercial profile.

  2. What drives SPS demand most: ED, inpatient, or chronic outpatient use?
    Demand is primarily driven by where binder protocols are used for acute management and where CKD and dialysis populations require ongoing hyperkalemia control.

  3. Why do newer potassium binders take share from SPS?
    Newer agents tend to align better with clinician priorities on gastrointestinal tolerability, predictable administration, and speed of potassium reduction in practice settings.

  4. What is the biggest commercial risk for SPS?
    Ongoing formulary substitution toward newer binders and tender-driven basket pricing pressures that compress mix.

  5. What is the biggest commercial lever for SPS manufacturers?
    Securing and maintaining binder-inclusive hospital formularies with contracts that sustain net price and utilization under GI safety protocols.


References

  1. FDA. Hyperkalemia drug information and product labeling resources (SPS resin binder labeling and safety communications). U.S. Food and Drug Administration.
  2. Drugs@FDA. Product-specific labeling records for sodium polystyrene sulfonate (SPS). U.S. Food and Drug Administration.
  3. PubMed. Sodium polystyrene sulfonate clinical studies and reviews. National Library of Medicine.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.