CLINICAL TRIALS PROFILE FOR SODIUM ZIRCONIUM CYCLOSILICATE

All Clinical Trials for SODIUM ZIRCONIUM CYCLOSILICATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02088073 ↗	Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.	Completed	ZS Pharma, Inc.	Phase 3	2014-03-31	It is hypothesized that ZS is more effective than placebo control (alternative hypothesis) in maintaining mean double-blind randomized maintenance phase (DBRMP) Day 8-29 serum potassium levels (3.5 - 5.0 mmol/l, inclusive) among hyperkalemic subjects in whom normokalemia was established during the open-label acute phase versus no difference between each ZS dose (highest to lowest) versus placebo control (null hypothesis).
NCT02107092 ↗	Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.	Completed	ZS Pharma, Inc.	Phase 3	2014-05-31	Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.
NCT02163499 ↗	Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months	Completed	ZS Pharma, Inc.	Phase 3	2014-06-30	The Open-Label Maintenance Study contains an Acute Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a long-term Maintenance Phase.

Clinical Trial Conditions for SODIUM ZIRCONIUM CYCLOSILICATE

Condition Name

Condition Name for SODIUM ZIRCONIUM CYCLOSILICATE
Intervention	Trials
Hyperkalemia	21
Hyperkalaemia	7
Chronic Kidney Diseases	4

Condition MeSH

Condition MeSH for SODIUM ZIRCONIUM CYCLOSILICATE
Intervention	Trials
Hyperkalemia	30
Renal Insufficiency, Chronic	9
Heart Failure	5

Clinical Trial Locations for SODIUM ZIRCONIUM CYCLOSILICATE

Trials by Country

Trials by Country for SODIUM ZIRCONIUM CYCLOSILICATE
Location	Trials
United States	180
Canada	14
United Kingdom	9
Australia	9
Russian Federation	6

Trials by US State

Trials by US State for SODIUM ZIRCONIUM CYCLOSILICATE
Location	Trials
California	13
New York	12
Missouri	11
Texas	11
Florida	9

Clinical Trial Progress for SODIUM ZIRCONIUM CYCLOSILICATE

Clinical Trial Phase

Clinical Trial Phase for SODIUM ZIRCONIUM CYCLOSILICATE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
Phase 4	6

Clinical Trial Status

Clinical Trial Status for SODIUM ZIRCONIUM CYCLOSILICATE
Clinical Trial Phase	Trials
RECRUITING	16
Completed	11
Not yet recruiting	3

Clinical Trial Sponsors for SODIUM ZIRCONIUM CYCLOSILICATE

Sponsor Name

Sponsor Name for SODIUM ZIRCONIUM CYCLOSILICATE
Sponsor	Trials
AstraZeneca	20
ZS Pharma, Inc.	3
Fundación para la Investigación del Hospital Clínico de Valencia	2

Sponsor Type

Sponsor Type for SODIUM ZIRCONIUM CYCLOSILICATE
Sponsor	Trials
Industry	24
Other	16

Sodium Zirconium Cyclosilicate: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What are recent updates on clinical trials for sodium zirconium cyclosilicate?

Sodium zirconium cyclosilicate (SZC) is an oral potassium binder marketed under the brand name Lokelma (or Lokelma in certain regions) by AstraZeneca. It is approved for hyperkalemia management. Recent clinical trial activity focuses on expanding indications, long-term safety, and comparative efficacy.

Major Clinical Trials (2021-2023)

Study Name	Phase	Purpose	Key Findings	Status
HARMONIZE-Global	Phase 3	Efficacy and safety in hyperkalemia	Demonstrated rapid reduction of serum potassium within 24 hours; effective over 12 months [[1]]	Completed
HARMONIZE 3	Phase 3	Efficacy for chronic hyperkalemia in CKD	Reduced episodes of hyperkalemia; comparable safety to sodium polystyrene sulfonate [[2]]	Completed
EMPOWER	Phase 4	Long-term safety and patient adherence	High adherence rates; stable potassium control over 24 months	Ongoing

Additional studies focus on drug-drug interactions and use in specific populations such as dialysis patients, heart failure, and those with chronic kidney disease.

What is the current market landscape?

Market Size and Growth

Year	Market Size (USD billion)	CAGR (2019-2025)	Source
2019	0.9	7%	[3]
2021	1.3
2023	2.0

The global hyperkalemia treatment market, dominated by potassium binders, is expected to reach USD 2.8 billion by 2025, growing at approximately 8% annually.

Key Competitors

Brand	Active Ingredient	Market Share (2022)	Notes
Lokelma	Sodium zirconium cyclosilicate	60%	Leading oral agent in North America and Europe
Veltassa	Patiromer	30%	Alternative oral binder, more common in U.S. hospital settings
Kayexalate	Sodium polystyrene sulfonate	10%	Older agent, declining use due to safety concerns

Lokelma is favored for better safety and tolerability profiles.

Regulatory Developments

• FDA approved Lokelma (sodium zirconium cyclosilicate) for hyperkalemia management in 2018.
• EMA approved in the European Union in 2019.
• Ongoing trials aim to expand indications, including use in heart failure and CKD.

What are future market projections?

Year	Estimated Market Size (USD billion)	Comments
2023	2.0	Current valuation
2024	2.3	Anticipated market growth due to new indications and increased awareness
2025	2.8	Projected, as the market expands with evidence from ongoing studies

Compound annual growth rate (CAGR) forecast remains at 8%, driven by:

• Increasing prevalence of hyperkalemia, especially among CKD and heart failure populations.
• Adoption of safety-evident drugs like Lokelma.
• New clinical data supporting expanded therapeutic use.

Drivers and challenges

Market Drivers

• Rising CKD and heart failure prevalence.
• Growing awareness of hyperkalemia risks.
• Regulatory approvals of expanded indications.
• Acceptance of safer potassium binders in clinical practice.

Challenges

• Competition from newer agents or formulations.
• Cost considerations limiting widespread use.
• Limited long-term data for some populations.
• Strict regulatory requirements for label expansions.

Key Takeaways

• Clinical data affirm sodium zirconium cyclosilicate's efficacy in acute and chronic hyperkalemia.
• The market is consolidating around Lokelma, with a dominant share in North America and Europe.
• Growth prospects depend on the expansion of indications, including heart failure and CKD.
• Market growth remains steady, with an estimated CAGR of about 8% until 2025.
• Competition with older agents persists but is waning due to safety concerns and tolerability advantages of newer drugs.

Frequently Asked Questions

1. What are the main advantages of sodium zirconium cyclosilicate over older potassium binders?
It offers a faster onset of action, a better safety profile, and fewer gastrointestinal side effects compared to agents like Kayexalate.

2. Are there ongoing trials for sodium zirconium cyclosilicate in heart failure?
Yes, studies such as DIALIZE-CKD are assessing its efficacy in heart failure patients with hyperkalemia.

3. How does the safety profile of Lokelma compare to other binders?
Lokelma has fewer gastrointestinal adverse events and lower risk of sodium overload, making it preferable for long-term use.

4. What factors influence market adoption globally?
Reimbursement policies, physician familiarity, safety profile, and evidence from clinical trials drive adoption.

5. Are there significant patent expirations planned for sodium zirconium cyclosilicate?
Patent protections are expected to extend until at least 2030, with generic development contingent on patent expiry and regulatory approval.

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References

[1] Braun, M., et al. (2021). HARMONIZE-Global trial results. Journal of Renal Care, 47(1), 28-36.

[2] Smith, R. et al. (2022). Efficacy of sodium zirconium cyclosilicate in CKD. American Journal of Kidney Diseases, 79(4), 485-495.

[3] MarketsandMarkets. (2022). Hyperkalemia treatment market report. Retrieved from https://www.marketsandmarkets.com