Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia
Phase of Trial: Phase III
Latest Information Update: 18 Jun 2019
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At a glance
- Drugs Zirconium silicate (Primary)
- Indications Hyperkalaemia
- Focus Adverse reactions; Registrational
- Sponsors ZS Pharma
- 18 May 2018 According to an AstraZaneca media release, based on the data of these studies (238578, 240595,240601, 242292 and 242482), the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
- 24 Feb 2017 According to an AstraZaneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia. The recommendation was based on data from this and three other phase III trials.
- 05 Jan 2017 Status changed from active, no longer recruiting to completed.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History