NDAORALFOR SUSPENSION
Approved
May 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
18
Data completeness
7/8 — Comprehensive
LOKELMA (sodium zirconium cyclosilicate) by AstraZeneca is (sodium zirconium cyclosilicate) is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium. Approved for hyperkalemia. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOKELMA (sodium zirconium cyclosilicate) is an oral suspension approved by the FDA in May 2018 for the treatment of hyperkalemia in adults. It is a non-absorbed zirconium silicate that selectively binds potassium ions in the gastrointestinal tract in exchange for hydrogen and sodium, increasing fecal potassium excretion and reducing serum potassium levels. The mechanism works even in the presence of other cations such as calcium and magnesium, making it effective across diverse patient populations. LOKELMA represents a novel ion-exchange approach to potassium management, distinct from traditional diuretics or dietary restriction.
$0.2BPart D
9.4 years to LOEMechanism of Action
(sodium zirconium cyclosilicate) is a non-absorbed zirconium silicate that preferentially captures potassium in exchange for hydrogen and sodium. In vitro , LOKELMA has a high affinity for potassium ions, even in the presence of other cations such as calcium and magnesium. LOKELMA increases fecal…
Indications (1)
Clinical Trials (18)
VITALIZE.Use and Effectiveness of Sodium Zirconium Cyclosilicate (LokelmaTM) in the Real-world Setting in Spain
Started Nov 2024
232 enrolled
Hyperkalaemia
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
Started Apr 2024
16 enrolled
HyperkalemiaDiet ModificationChronic Kidney Disease+1 more
A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece
Started Feb 2024
125 enrolled
Hyperkalaemia
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia
Started Apr 2022
88 enrolled
Hyperkalemia
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
Started Mar 2022
186 enrolled
HyperkalaemiaChronic Kidney Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.