Sodium Zirconium Cyclosilicate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOKELMA | — | 2020-04-24 | fda.gov ↗ |
| Approved | US (FDA) | LOKELMA | — | 2018-05-18 | fda.gov ↗ |
| Approved | EU (EMA) | Lokelma | — | 2018-03-22 | europa.eu ↗ |
Trials 29 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04788641 | Mar → Sep 2021 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04727840 | Mar 2021 → Jan 2022 | chronic kidney disease | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03283267 | Oct → Nov 2017 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04983979 | Jun 2022 → Mar 2023 | chronic kidney disease, type 2 diabetes mellitus | Barts & The London NHS Trust | Terminated | No outcome recorded |
| Phase 2 | NCT04789239 | Sep 2021 → Dec 2025 overdue | heart failure | Michael Fu | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03532009 | Jun 2018 → May 2020 | heart failure | AstraZeneca | Terminated | No outcome recorded |
| Phase 2 | NCT03337477 | Feb → Dec 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03127644 | Jun 2017 → Feb 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT06578078 | Oct 2024 → Dec 2026 expected | chronic kidney disease, heart failure | Fundación para la Investigación del Hospital Clínico de Valencia | Recruiting | No outcome recorded |
| Phase 3 | NCT06578533 | Sep 2022 → Jul 2025 overdue | chronic kidney disease | Fundación para la Investigación del Hospital Clínico de Valencia | Recruiting | No outcome recorded |
| Phase 3 | NCT05056727 | Sep 2021 → Feb 2024 | chronic kidney disease | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT03528681 | May 2021 → Sep 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT04847232 | Apr 2021 → Mar 2024 | — | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04727528 | Mar 2021 → Sep 2022 | chronic kidney disease, metabolic acidosis | AstraZeneca | Terminated | No outcome recorded |
| Phase 3 | NCT04217590 | Nov 2020 → Jan 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03813407 | Apr 2019 → Feb 2030 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT03303521 | Dec 2017 → Nov 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02875834 | Mar 2017 → Feb 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT05382988 | Nov 2016 → Dec 2021 | secondary hyperparathyroidism of renal origin | Guangdong Provincial People's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02163499 | Jun 2014 → Nov 2016 | — | ZS Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02107092 | May 2014 → Jul 2015 | — | ZS Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02088073 | Mar → Aug 2014 | — | ZS Pharma, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01737697 | Nov 2012 → Oct 2013 | — | ZS Pharma, Inc. | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06736184 | Mar 2025 → Dec 2026 expected | chronic kidney disease, potassium deficiency | Qianfoshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05535920 | Apr 2022 → Apr 2024 | — | NephroNet, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT05347693 | Mar 2022 → Dec 2024 | chronic kidney disease | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT04997161 | Aug → Nov 2021 | — | AstraZeneca | Terminated | No outcome recorded |
| Phase 4 | NCT04676646 | Mar 2021 → Jul 2024 | symptomatic heart failure | AstraZeneca | Completed | No outcome recorded |
| Phase 4 | NCT04585542 | Oct 2020 → Jan 2025 | — | University of California, Irvine | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07576257 Comparator | Sep 2026 → Dec 2029 expected | heart failure | Sahlgrenska University Hospital | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05004363 Comparator | Jan 2022 → Jul 2024 | chronic kidney disease, symptomatic heart failure | St George's, University of London | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06365684 Background | Apr 2024 → May 2025 | chronic kidney disease | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT04063930 Comparator | Oct 2019 → Dec 2020 | diabetic kidney disease | Steno Diabetes Center Copenhagen | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06029179 Comparator | Jan → Oct 2024 | — | Alexandria University | Completed | No outcome recorded |
| — | NCT04207203 Background | Nov 2020 → Apr 2023 | chronic kidney disease | Karolinska Institutet | Completed | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sodium zirconium cyclosilicate | “We investigated whether sodium zirconium cyclosilicate (ZS-9), a novel selective cation exchanger, could lower serum potassium levels in patients with hyperkalemia.” PMID 25415807 ↗ Nov 201433“the orally administered potassium binder sodium zirconium cyclosilicate (Lokelma) to treat interdialytic hyperkalemia” NCT05535920 ↗ “Investigational Medicinal Product Sodium Zirconium Cyclosilicate” NCT05004363 ↗ “Sodium zirconium cyclosilicate (a hyperkalemia treatment)” NCT04063930 ↗ “Sodium Zirconium Cyclosilicate” NCT07576257 ↗ |
| Known as | Lokelma | “A Randomized, Double-blind, Placebo Controlled, Parallel, Multicenter Study of the Effects of 12-weeks of Sodium Zirconium Cyclosilicate (Lokelma) on Albuminuria (UACR) in...” NCT04063930 ↗3“the orally administered potassium binder sodium zirconium cyclosilicate (Lokelma) to treat interdialytic hyperkalemia” NCT05535920 ↗ “Sodium zirconium cyclosilicate (SZC) (Lokelma)®, 5 g, 10 g, orally, is an approved drug in Sweden.” NCT04789239 ↗ |
| Known as | Sodium Zirconium Cyclosilicate (SZC) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05056727 ↗ |
| Known as | SZC | “The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients...” PMID 38878009 ↗ May 202416“We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.” PMID 31791288 ↗ Dec 2019 “This study aimed to determine whether using sodium zirconium cyclosilicate (SZC) would lower the risk of hyperkalemia in patients with maintenance hemodialysis after PTX.” PMID 39969301 ↗ Dec 2024 “Sodium zirconium cyclosilicate (SZC) is an orally administered non-absorbed intestinal potassium binder proven to lower serum potassium concentrations.” PMID 36564955 ↗ Dec 2022 “Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.” PMID 32779057 ↗ Aug 2020 “Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients.” PMID 35135481 ↗ Feb 2022 “Sodium zirconium cyclosilicate (SZC) is a nonabsorbed potassium binder proven to lower serum potassium (S-K) and maintain normokalaemia.” NCT06578078 ↗ “Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for the treatment of adults with hyperkalaemia.” PMID 32030422 ↗ Jan 2021 “Sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate (SPS) for treatment of hyperkalemia in HD patients.” PMID 40329202 ↗ May 2025 “New potassium binders, e.g. Sodium Zirconium Cyclosilicate (SZC), reduce incidence of hyperkalaemia in CKD-HF patients” NCT05004363 ↗ “PURPOSE: Sodium zirconium cyclosilicate (SZC) is an oral potassium (K+)-lowering therapy for adults with hyperkalemia.” PMID 39112102 ↗ Aug 2024 “Sodium zirconium cyclosilicate (SZC), a non-absorbed cation exchanger, selectively binds potassium in the intestine.” NCT04727840 ↗ “Sodium Zirconium Cyclosilicate (SZC) Dose: Paediatric dose based on body weight equivalent to an adult 2.5 g” NCT03813407 ↗ “the potassium binder sodium zirconium cyclosilicate (SZC)” PMID 39032787 ↗ Jul 2024 “Sodium Zirconium Cyclosilicate (SZC)” NCT04788641 ↗ “Sodium Zirconium Cyclosilicate (SZC)” NCT04847232 ↗ “Sodium Zirconium Cyclosilicate (SZC)” NCT06736184 ↗ |
| Known as | UXSi-9 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301592 ↗ |
| Known as | ZS-9 | “We examined the efficacy and safety of sodium zirconium cyclosilicate (SZC; formerly ZS-9) treatment for ≤ 48 h in patients with baseline serum potassium level ≥ 5.5 mmol/L.” PMID 31791288 ↗ Dec 20192“We investigated whether sodium zirconium cyclosilicate (ZS-9), a novel selective cation exchanger, could lower serum potassium levels in patients with hyperkalemia.” PMID 25415807 ↗ Nov 2014 “Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder for the treatment of adults with hyperkalaemia.” PMID 32030422 ↗ Jan 2021 |
| Modality | Other / unclassified | “Sodium zirconium cyclosilicate (SZC; formerly ZS-9) is a selective potassium (K+) binder” PMID 32030422 ↗ Jan 2021 |
| Route | Oral | “Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.” NCT01737697 ↗ |