KIONEX (sodium polystyrene sulfonate)
KIONEX is indicated for the treatment of Hyperkalemia.
Details
- Status
- Prescription
- First Approved
- 1998-02-06
- Routes
- ORAL, RECTAL
- Dosage Forms
- SUSPENSION, POWDER
KIONEX Approval History
What KIONEX Treats
1 indicationsKIONEX is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperkalemia
KIONEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
KIONEX FDA Label Details
Indications & Usage
KIONEX is indicated for the treatment of Hyperkalemia.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.