Lupin has received approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Sodium Zirconium Cyclosilicate for Oral Suspension, available in 5 g/packet and 10 g/packet strengths.
The product is approved as a bioequivalent to AstraZeneca’s Lokelma and is indicated for the treatment of high levels of potassium in the blood or hyperkalemia in adults.
According to IQVIA MAT June 2026 data, Lokelma had estimated annual sales of $568 million in the US.
Hyperkalemia: Causes, Signs and Symptoms
Potassium is essential for the normal functioning of cells, muscles, nerves and the heart, as well as for digestive and bone health. However, excessively high levels of potassium in the blood can be dangerous, a condition known as hyperkalemia.
The kidneys play an important role in regulating potassium levels by filtering the blood and removing excess potassium through urine. When kidney function is impaired, potassium can accumulate in the blood and rise above the normal range.
Potassium levels are typically measured through a blood test. A normal blood potassium level is generally between 3.5 and 5.0 mEq/L. Although in some cases, up to 5.2 mEq/L is considered normal.
People with certain health conditions or those taking certain medications may be at increased risk of hyperkalemia. Risk factors include kidney disease, high blood pressure, diabetes, heart failure and certain medicines used to treat these conditions.
Hyperkalemia may not cause noticeable symptoms and is often detected during routine blood tests. When symptoms occur, they can include muscle fatigue, weakness, tingling or unusual sensations.
Severe hyperkalemia can be life-threatening and may cause serious symptoms such as a fluttering or pounding heartbeat, shortness of breath, chest pain, paralysis, nausea or vomiting. People experiencing severe symptoms should seek immediate medical attention.
Sodium Zirconium Cyclosilicate for Oral Suspension helps lower elevated blood potassium levels. However, it is not recommended as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
