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news.US-based biopharmaceutical firm ZS Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for its lead therapeutic candidate, ZS-9 (sodium zirconium cyclosilicate), to treat hyperkalemia.
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ZS-9 is an insoluble, non-absorbed zirconium silicate and it has a clearly defined three-dimensional crystalline lattice structure that was designed and engineered to preferentially trap potassium ions.
The potassium selectivity of ZS-9 allows high in-vitro binding capacity for potassium ions even in the presence of other competing ions.
The company said that ZS-9, an investigational product, is not approved for any indication in any market.
ZS Pharma chief executive officer Robert Alexander said: "The submission of the NDA for ZS-9 is a major milestone for ZS Pharma and we look forward to working closely with the FDA during the review period.
"If approved, ZS-9 would provide physicians with an important tool to treat hyperkalemia."
ZS Pharma’s ZS-9 is being evaluated in late-stage clinical trials to show its ability to safely and effectively remove excess potassium from the blood and maintain normal potassium levels.
The company is also pursuing the discovery of additional drug candidates that use its new selective ion-trap technology to treat kidney and liver diseases.