TheraRadar
Data updated: Sep 20, 2026

SODIUM ZIRCONIUM CYCLOSILICATE · ALKEM LABS LTD

Generic · see LOKELMA Trial Activity: Stable 4 active trials
Renal Approved 2018-05-18

SODIUM ZIRCONIUM CYCLOSILICATE is FDA-approved to treat 1 condition (same as LOKELMA).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

AstraZeneca conducting 5 trials (33%)
14 indications explored (Broad Platform)
→ hyperkalemia (8 trials)
→ heart failure (3 trials)
→ hyperkalaemia (3 trials)
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2018-05-18
Routes
ORAL
Dosage Forms
POWDER, FOR SUSPENSION, FOR SUSPENSION

Companies

ALKEM LABS LTD Lupin
Active Ingredient: SODIUM ZIRCONIUM CYCLOSILICATE

SODIUM ZIRCONIUM CYCLOSILICATE Approval History

Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
Aug 2026 ORIGINAL
Update

What SODIUM ZIRCONIUM CYCLOSILICATE Treats

1 indications

SODIUM ZIRCONIUM CYCLOSILICATE is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyperkalemia

Same approved indications as LOKELMA (same active ingredient).

Source: FDA Label
📋

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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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 ZIRCONIUM CYCLOSILICATE FDA Label Details

Indications & Usage

SODIUM ZIRCONIUM CYCLOSILICATE is FDA-approved to treat 1 condition — same approved indications as LOKELMA.

Looking for the branded version?

LOKELMA

Full clinical data, patents, trials, and competitive landscape for sodium zirconium cyclosilicate.

See LOKELMA

Data Sources

FDA Approval: ANDA217558 → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment