AstraZeneca Gets SEC Approval to Conduct Phase IV Trial of Hyperkalemia Drug Sodium Zirconium Cyclosilicate
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO), has granted approval to the drug major AstraZeneca Pharma India to conduct a Phase-IV Clinical trial of Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g, used to treat hyperkalemia.
This came after AstraZeneca Pharma India presented the Phase IV clinical trial protocol of the drug Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g (Protocol no. D9480L00025, Ver. 1.0 dated 30.05.2025), before the committee.
The firm presented the study objective, study design, inclusion and exclusion criteria, risk assessment and mitigation strategy, dose modification criteria, management and reporting of adverse event (AE), safety evaluation, statistical analysis methodology, and sample size to be enrolled in the study, etc.
Sodium zirconium cyclosilicate is approved as the trade product Lokelma, developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent.
Hyperkalemia is a condition defined by elevated potassium levels in the blood, often caused by cardiovascular, renal, and metabolic diseases. Hyperkalemia occurs in 23 to 47% of patients with chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death.
Sodium zirconium cyclosilicate is subsequently a non-absorbed, non-polymer inorganic powder with a uniform micropore structure that preferentially captures potassium in exchange for hydrogen and sodium cations. Sodium zirconium cyclosilicate is highly selective for potassium ions, even in the presence of other cations such as calcium and magnesium, in vitro. Sodium zirconium cyclosilicate captures potassium throughout the entire gastrointestinal (GI) tract and reduces the concentration of free potassium in the GI lumen, thereby lowering serum potassium levels and increasing fecal potassium excretion to resolve hyperkalemia.
At the recent SEC meeting, the expert panel reviewed the Phase IV clinical trial protocol of the drug Sodium Zirconium Cyclosilicate powder for oral Suspension 5/ 10 g (Protocol no. D9480L00025, Ver. 1.0 dated 30.05.2025).
After detailed deliberation, the committee recommended the grant of permission to conduct a Phase-IV Clinical trial as per the protocol presented by the firm.
