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# AstraZeneca Resubmits NDA for Hyperkalemia Drug
- URL: https://www.fdaweb.com/astrazeneca-resubmits-nda-for-hyperkalemia-drug/
- Published: 2016-10-18T12:00:00.000Z
- Updated: 2026-09-14T21:40:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137097

FDA has accepted an AstraZeneca NDA re-submission for sodium zirconium cyclosilicate (ZS-9), indicated for treating hyperkalemia (high potassium level in the blood serum). A complete response letter was sent in May to the company that identified observations cited during a pre-approval manufacturing inspection. The agency did not request any new data, AstraZeneca says.

ZS-9 is an insoluble, non-absorbed zirconium silicate with a three-dimensional crystalline lattice structure that was designed to preferentially trap potassium ions, AstraZeneca says. “The unique potassium selectivity of ZS-9 enables high in-vitro binding capacity for potassium ions even in the presence of other competing ions,” it says. The therapy has been studied in three double-blind, placebo-controlled trials, and in two ongoing 12-month open label studies in over 1,600 patients.