LOKELMA (sodium zirconium cyclosilicate)
LOKELMA is indicated for the treatment of Hyperkalemia.
How LOKELMA Works
Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate compound that acts as a selective cation exchanger. It preferentially captures potassium ions throughout the lumen of the gastrointestinal tract in exchange for hydrogen and sodium ions. By binding free potassium and increasing its excretion via the feces, the medication effectively lowers systemic serum potassium levels. It maintains high affinity for potassium even in the presence of competing cations such as calcium and magnesium.
Details
- Status
- Prescription
- First Approved
- 2018-05-18
- Patent Cliff
- 2035
- Revenue
- $181M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION
LOKELMA Approval History
What LOKELMA Treats
1 indicationsLOKELMA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hyperkalemia
LOKELMA 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.
Drugs Similar to LOKELMA
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04585542 KBindER results posted | HS# 2020-5780 | Ph 4 | terminated | Comparison of Potassium Binders in the ER |
| NCT06578078 SENEKA | SENEKA 2024-513971-42-00 | Ph 3 | recruiting | A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients |
| NCT04676646 REALIZE-K results posted | D9480C00018 2020-003312-27 | Ph 4 | completed | Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone |
| NCT04789239 OPRA-HF | ESR-19-20262 | Ph 2 | active not recruiting | OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure |
| NCT04983979 ORTIZ results posted | 136721 | Ph 2 | terminated | The ORTIZ Study: Optimising RASi Therapy With SZC |
| NCT06578533 KEEP-ON | KEEP-ON | Ph 3 | recruiting | Keeping RAASi Treatment With Optimal Potassium Control |
| NCT04788641 results posted | D9480C00012 2020-000515-68 | Ph 1 | completed | Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects |
| NCT04727528 NEUTRALIZE results posted | D9480C00022 | Ph 3 | terminated | Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease |
| NCT04217590 DIALIZE China results posted | D9485C00001 | Ph 3 | completed | Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects |
| NCT05382988 SZC | SZC AFTER PTX | Ph 3 | completed | Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy |
| NCT03532009 PRIORITIZE HF results posted | D9484C00001 | Ph 2 | terminated | Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure |
| NCT02088073 results posted | ZS-004 | Ph 3 | completed | Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia. |
| NCT02107092 results posted | ZS-004E | Ph 3 | completed | Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia. |
| NCT02163499 results posted | ZS-005 | Ph 3 | completed | Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months |
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.
LOKELMA FDA Label Details
Indications & Usage
FDA Label (PDF)LOKELMA is indicated for the treatment of Hyperkalemia.
LOKELMA Patents & Exclusivity
Patents (14 active)
Pro Intelligence Preview
Deep insights for LOKELMA
Revenue Insights
- • Q4-2025: $181M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 54 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.