RLY5016 is a high capacity cation binder being developed for the treatment of hyperkalemia in patients with diabetes, chronic kidney disease (CKD) and heart failure. The company is currently enrolling patients in a pivotal Phase 3 clinical study under an agreed upon special protocol assessment with the U.S. Food and Drug Administration.
Hyperkalemia is a serious medical condition that may lead to arrhythmia and sudden cardiac death. Currently, only acute treatments in the hospital setting are available and significantly limited by side effects. Chronic kidney disease and heart failure patients are the most likely populations to develop hyperkalemia due to impaired kidney function.
Use of renin-angiotensin-aldosterone system (RAAS) inhibitors (ACE inhibitors, ARBs, aldosterone antagonists) has been shown to reduce mortality in CHF and CKD patients. However, potassium retention, leading to increased serum potassium, is a significant challenge to the broader use of RAAS inhibitor treatment.
Summarized below is the status of Relypsa's leading drug candidates:
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