Drugs / Zirconium Cyclosilicate
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | potassium deficiency | 2017-03-17 | “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).” astrazeneca.com ↗ |
| Filed | US (FDA) | — | potassium deficiency | 2016-10-18 | “the US Food and Drug Administration (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 | “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)” astrazeneca.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT03172702 | Sep 2017 → Jul 2019 | — | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
AstraZeneca will present a series of sub-analyses from the Lokelma Phase IIIb DIALIZE trial reinforcing the effectiveness of this medicine to manage hyperkalaemia in patients with CKD on haemodialysis, irrespective of factors such as sex, country, age, weight or disease severity. |
| 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 ↗
For Lokelma (sodium zirconium cyclosilicate), a post-hoc analysis evaluating potassium balance from the Phase IIIb DIALIZE trial will show efficacy and safety data of the medicine in patients with hyperkalaemia on haemodialysis. |
| 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. |
| 2018-10-22 | AstraZeneca | Results AstraZeneca to present new data demonstrating breadth of research portfolio in renal disease at ASN Kidney Week 2018 astrazeneca.com ↗
These findings add to the growing body of evidence for Lokelma and will support regulatory filings in those markets. |
| 2018-05-18 | AstraZeneca | Regulatory Lokelma approved in the US for the treatment of adults with hyperkalaemia astrazeneca.com ↗
The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalaemia, 1 a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. |
| 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 ↗ |
| 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 ↗
27 May 2016 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 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Zirconium Cyclosilicate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03172702 ↗ |
| Known as | SZC | “Sodium zirconium cyclosilicate (SZC), an oral, highly selective cation-exchanger, is approved for the treatment of hyperkalemia.” PMID 33098526 ↗ Oct 2020 |
| Route | Oral | “Sodium zirconium cyclosilicate (SZC), an oral, highly selective cation-exchanger” PMID 33098526 ↗ Oct 2020 |