Novel Hyperkalemia Drug Awaits FDA Action

ZS Pharma is requesting FDA approval for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalemia.

ZS-9 is an investigational insoluble, non-absorbed zirconium silicate with a crystalline lattice structure designed to trap potassium ions. In fact, the drug demonstrated a >25-­fold selectivity for potassium ions over calcium and magnesium ones in an in vitro study.

According to ZS Pharma, this selectivity helps lower and maintain serum potassium levels in patients with hyperkalemia, a condition caused by abnormally high levels of potassium in the blood.

"The submission of the [New Drug Application] for ZS-9 is a major milestone for ZS Pharma, and we look forward to working closely with the FDA during the review period," said ZS Pharma CEO Robert Alexander, PhD, in a statement. "If approved, ZS-9 would provide physicians with an important tool to treat hyperkalemia."

The product is currently not approved for any indication in any market.