TheraRadar
Data updated: May 26, 2026

SODIUM POLYSTYRENE SULFONATE

Potassium Ion Exchange Activity
Renal Approved 1984-09-11

SODIUM POLYSTYRENE SULFONATE is indicated for the treatment of Hyperkalemia.

Source: FDA Label • ROXANE
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
11
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Discontinued
First Approved
1984-09-11
Routes
ORAL, RECTAL
Dosage Forms
SUSPENSION, POWDER

Companies

ROXANE CITRUSPHRMA UPSHER SMITH LABS ANI PHARMS MORTON GROVE PAI HOLDINGS PHARM CMP PHARMA INC NUVO PHARMS INC Hikma EPIC PHARMA LLC CHARTWELL RX AJENAT PHARMS LYNE
Active Ingredient: SODIUM POLYSTYRENE SULFONATE

SODIUM POLYSTYRENE SULFONATE Approval History

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Original
New Indication
New Form
Label Update
57 FDA actions from 1984 to 2025
Jun 2025 ORIGINAL
Update
Feb 2020 SUPPL
Label · Labeling
Feb 2020 SUPPL
Label · Labeling

What SODIUM POLYSTYRENE SULFONATE Treats

1 indications

SODIUM POLYSTYRENE SULFONATE is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyperkalemia
Source: FDA Label

SODIUM POLYSTYRENE SULFONATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

LOKELMA
AstraZeneca
2018 1 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SODIUM POLYSTYRENE SULFONATE

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

KALEXATE
SODIUM POLYSTYRENE SULFONATE
1 shared
KVK TECH
Shared indications:
Hyperkalemia
KIONEX
SODIUM POLYSTYRENE SULFONATE
1 shared
ANI PHARMS
Shared indications:
Hyperkalemia
LOKELMA
SODIUM ZIRCONIUM CYCLOSILICATE
1 shared
AstraZeneca
Shared indications:
Hyperkalemia
View all 4 similar drugs Pro
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02065076 SKIP 13089 Ph 4 completed Efficacy of Sodium Polystyrene Sulfonate in the Treatment of Hyperkaliemia in Pre-dialysis Patients
NCT01866709 results posted SPS-001 Ph 4 terminated Safety and Efficacy of Sodium Polystyrene Sulfonate in Hyperkalemia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SODIUM POLYSTYRENE SULFONATE FDA Label Details

Indications & Usage

SODIUM POLYSTYRENE SULFONATE is indicated for the treatment of Hyperkalemia.

Looking for the branded version?

SPS

Full clinical data, patents, trials, and competitive landscape for sodium polystyrene sulfonate.

See SPS

Data Sources

FDA Approval: ANDA088453 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.