ZS-9 is an insoluble, non-absorbed zirconium silicate with a three-dimensional crystalline lattice structure that was designed 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 Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is 26 May 2016.
ZS Pharma chief executive officer Robert Alexander said: "Hyperkalemia is a serious condition with few treatment options and ZS-9 could be the first selective agent approved for the treatment of this condition.
"The acceptance of the NDA is an important step toward making ZS-9 potentially available to patients with hyperkalemia."
The company has examined ZS-9 in three double-blind, placebo controlled trials and in two ongoing 12 month open label studies in patients with hyperkalemia which represents more than 1,600 patients treated with ZS-9.
According to the company, its investigational product ‘ZS-9’ has not been approved for any indication in any market.