TheraRadar
Data updated: May 26, 2026

SPS (sodium polystyrene sulfonate)

Potassium Ion Exchange Activity
Renal Approved 1982-12-08

SPS is indicated for the treatment of Hyperkalemia.

Source: FDA Label • CMP PHARMA INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
43
Years on Market

Details

Status
Prescription
First Approved
1982-12-08
Routes
ORAL, RECTAL
Dosage Forms
SUSPENSION

Companies

CMP PHARMA INC
Active Ingredient: SODIUM POLYSTYRENE SULFONATE

SPS Approval History

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Original
New Indication
New Form
Label Update
12 FDA actions from 1982 to 2011
Jun 2011 SUPPL
Label · Labeling
Mar 2011 SUPPL
Label · Labeling
Mar 2004 SUPPL
Label · Labeling

What SPS Treats

1 indications

SPS is approved for 1 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyperkalemia
Source: FDA Label

SPS 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 SPS

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
📋

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
🔬

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.

SPS FDA Label Details

Indications & Usage

SPS is indicated for the treatment of Hyperkalemia.

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Data Sources

FDA Approval: ANDA087859 → Label: DailyMed → Trials: ClinicalTrials.gov →

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