Sodium Zirconium Cyclosilicate
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed potassium deficiency 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | potassium deficiency | 2017-03-17 | “FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).” astrazeneca.com ↗ |
| Filed | US (FDA) | — | potassium deficiency | 2016-10-18 | “FDA has accepted a complete re-submission of a New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9)” astrazeneca.com ↗ |
| Rejected (CRL) | US (FDA) | — | potassium deficiency | 2016-05-27 | “FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9)” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 28
| 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 · 3 missed | ||||||
| Phase 2 | NCT04983979 | Jun 2022 → Mar 2023 | chronic kidney disease, type 2 diabetes mellitus | Barts & The London NHS Trust | Terminated | Missed primary Stop: Enrollment |
| 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 | Missed primary |
| Phase 2 | NCT03337477 | Feb → Dec 2018 | — | AstraZeneca | Completed | Missed primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03127644 | Jun 2017 → Feb 2018 | — | AstraZeneca | Completed | Met primary |
| Phase 314 trials · 7 met primary · 1 missed | ||||||
| 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 2027 expected | chronic kidney disease | Fundación para la Investigación del Hospital Clínico de Valencia | Recruiting | No outcome recorded |
| Phase 3 | NCT03528681 | May 2021 → Sep 2022 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT04847232 | Apr 2021 → Mar 2024 | — | AstraZeneca | Terminated | Missed primary |
| Phase 3 | NCT04727528 | Mar 2021 → Sep 2022 | chronic kidney disease, metabolic acidosis | AstraZeneca | Terminated | Met primary Stop: Enrollment |
| Phase 3 | NCT04217590 | Nov 2020 → Jan 2022 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT03813407 | Apr 2019 → Feb 2030 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT03303521 | Dec 2017 → Nov 2018 | — | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT02875834 | Mar 2017 → Feb 2018 | — | AstraZeneca | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT01737697 | Nov 2012 → Oct 2013 | — | ZS Pharma, Inc. | Completed | Met primary |
| Phase 46 trials · 1 met primary | ||||||
| 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 | Met primary |
| Phase 4 | NCT04585542 | Oct 2020 → Jan 2025 | — | University of California, Irvine | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy6 trials | ||||||
| Phase 2 | NCT07576257 Comparator | Sep 2026 → Dec 2029 expected | heart failure | Sahlgrenska University Hospital | Not yet recruiting | No outcome recorded |
| 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 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2026-08-10 | Lupin Limited | Regulatory Lupin Announces the Approval of Sodium Zirconium Cyclosilicate for Oral Suspension in the United States lupin.com ↗
The U.S. FDA has approved Lupin's Sodium Zirconium Cyclosilicate for Oral Suspension, 5 g/packet and 10 g/packet |
| 2020-06-05 | AstraZeneca | Results AstraZeneca presents new data across continuum of care from its broad renal portfolio at ERA-EDTA 2020 Virtual Congress astrazeneca.com ↗
Sodium Zirconium Cyclosilicate Corrects Hyperkalaemia Within 72 hours Among Outpatients With Severe Hyperkalaemia (Baseline Serum Potassium ≥6 mmol/L) Regardless of Renal Function Level or RAASi Use |
| 2020-03-31 | AstraZeneca | Regulatory Lokelma recommended for approval in EU for patients with hyperkalaemia on stable haemodialysis astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a dosing and administration label update for AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) to include patients with hyperkalaemia on stable haemodialysis. |
| 2020-03-26 | AstraZeneca | Regulatory Lokelma approved in Japan for the treatment of hyperkalaemia astrazeneca.com ↗
AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in Japan for the treatment of patients with hyperkalaemia (elevated levels of potassium in the blood). |
| 2020-01-06 | AstraZeneca | Regulatory Lokelma approved in China for the treatment of adult patients with hyperkalaemia astrazeneca.com ↗
AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) has been approved in China for the treatment of adult patients with hyperkalaemia (elevated levels of potassium in the blood). |
| 2019-10-30 | AstraZeneca | Results AstraZeneca to present pivotal roxadustat Phase III data at the American Society of Nephrology Kidney Week 2019 astrazeneca.com ↗
Sodium Zirconium Cyclosilicate Improves Potassium Balance in Hyperkalemic Hemodialysis Patients: Results from the Phase 3b, Randomized, Placebo Controlled DIALIZE Study |
| 2019-06-14 | AstraZeneca | Results Lokelma demonstrated efficacy in treating hyperkalaemia in patients with end-stage renal disease on haemodialysis astrazeneca.com ↗
AstraZeneca today presented positive results from the Phase IIIb DIALIZE trial which investigated the efficacy and safety of Lokelma (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia in patients with end-stage renal disease (ESRD) on haemodialysis. |
| 2018-10-25 | AstraZeneca | Results Phase III HARMONIZE Global trial of Lokelma confirms efficacy in maintaining normal potassium levels in Asian patients with hyperkalaemia astrazeneca.com ↗
Results show normokalaemia was maintained with statistically-significant differences observed, irrespective of dose, for Lokelma vs. placebo in terms of mean potassium levels during days 8-29 of the maintenance phase. |
| 2018-05-18 | AstraZeneca | Regulatory Lokelma approved in the US for the treatment of adults with hyperkalaemia astrazeneca.com ↗
We are pleased by today’s FDA approval of Lokelma as it enables us to help address a long-standing clinical need with a new medicine that offers rapid and sustained treatment for adults with hyperkalaemia. |
| 2018-03-22 | AstraZeneca | Regulatory Lokelma approved in the EU for the treatment of adults with hyperkalaemia astrazeneca.com ↗
AstraZeneca today announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. |
| 2017-03-17 | AstraZeneca | Regulatory AstraZeneca receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate). |
| 2017-02-24 | AstraZeneca | Regulatory ZS-9 (sodium zirconium cyclosilicate) receives positive CHMP opinion for the treatment of hyperkalaemia astrazeneca.com ↗
AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia, a serious condition characterised by high potassium levels in the blood serum caused by cardiovascular, renal and metabolic diseases. |
| 2016-10-18 | AstraZeneca | Regulatory FDA accepts for review New Drug Application for sodium zirconium cyclosilicate (ZS-9) for the treatment of hyperkalaemia astrazeneca.com ↗ |
| 2016-05-27 | AstraZeneca | Regulatory AstraZeneca receives Complete Response Letter from US FDA for sodium zirconium cyclosilicate (ZS-9) for oral suspension for treatment of hyperkalaemia astrazeneca.com ↗
AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. |
All press releases naming this drug 14 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 46 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 | 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 “PURPOSE: Sodium zirconium cyclosilicate (SZC) is an oral potassium (K+)-lowering therapy for adults with hyperkalemia.” PMID 39112102 ↗ Aug 2024 “New potassium binders, e.g. Sodium Zirconium Cyclosilicate (SZC), reduce incidence of hyperkalaemia in CKD-HF patients” NCT05004363 ↗ |
| 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 ↗ |