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# Fast Track for AstraZeneca Lokelma Indication
- URL: https://www.fdaweb.com/fast-track-for-astrazeneca-lokelma-indication/
- Published: 2021-11-17T12:00:00.000Z
- Updated: 2026-09-14T17:22:41.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150594

FDA has granted fast track designation to AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for a new indication to reduce arrhythmia-related cardiovascular outcomes in patients on chronic hemodialysis with recurrent hyperkalemia. The company [says](https://www.businesswire.com/news/home/20211117006015/en/LOKELMA%C2%AE-Granted-Fast-Track-Designation-in-the-US-to-Reduce-Cardiovascular-Outcomes-in-Patients-on-Chronic-Hemodialysis-With-Hyperkalemia?ref=fdaweb.com) the designation is based on Lokelma’s potential to reduce serious adverse cardiovascular outcomes in that patient population, addressing a significant unmet medical need, that is being investigated in the Phase 3 DIALIZE-Outcomes trial.

Lokelma is described as a highly selective oral potassium-removing agent currently approved in the U.S. and several other countries for treating hyperkalemia.