Skip to main content

Hyperkalemia

20
Pipeline Programs
6
Companies
19
Clinical Trials
3 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
5
1
7
5
Early DiscoveryClinical DevelopmentMarket

On Market (3)

Approved therapies currently available

AstraZeneca
LOKELMAApproved
sodium zirconium cyclosilicate
AstraZeneca
oral2018
205M Part D
VELTASSAApproved
patiromer
Unknown Company
Potassium Binder [EPC]oral2015
154M Part D
AstraZeneca
SODIUM ZIRCONIUM CYCLOSILICATEApproved
sodium zirconium cyclosilicate
AstraZeneca

Competitive Landscape

6 companies ranked by most advanced pipeline stage

AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
11 programs
1
1
5
2
LOKELMA 5 GM Powder for Oral SuspensionPhase 41 trial
Sodium zirconium cyclosilicatePhase 41 trial
Sodium Zirconium CyclosilicatePhase 31 trial
Sodium Zirconium CyclosilicatePhase 31 trial
Sodium Zirconium CyclosilicatePhase 31 trial
+6 more programs
Active Trials
NCT05408039Completed1,331Est. Dec 2024
NCT06884267Recruiting1,000Est. Nov 2027
NCT03283267Completed22Est. Nov 2017
+8 more trials
Waterstone Pharmaceuticals
3 programs
1
1
1
WS016Phase 31 trial
WS016 3gPhase 21 trial
WS016 Single DosePhase 11 trial
Active Trials
NCT06281470Completed66Est. Jun 2023
NCT06277128Unknown140Est. Aug 2024
NCT07251309Recruiting420Est. Nov 2026
Syneos Health
Syneos HealthNC - Morrisville
1 program
1
PatiromerPhase 31 trial
Active Trials
NCT03888066Completed1,195Est. Sep 2021
Ardelyx
ArdelyxCA - Fremont
2 programs
2
RDX013Phase 21 trial
RDX227675Phase 21 trial
Active Trials
NCT04780841Completed109Est. Mar 2022
NCT03018067Terminated60Est. May 2017
Zeria Pharmaceutical
1 program
1
patiromerPhase 21 trial
Active Trials
NCT03799926Completed184Est. Feb 2021
Medpace
MedpaceCINCINNATI, OH
1 program
1
patiromerPhase 21 trial
Active Trials
NCT00868439Completed120Est. Dec 2009

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
AstraZenecaSodium zirconium cyclosilicate
AstraZenecaLOKELMA 5 GM Powder for Oral Suspension
Waterstone PharmaceuticalsWS016
AstraZenecaSodium Zirconium Cyclosilicate 5g
AstraZenecaSodium Zirconium Cyclosilicate
AstraZenecaSodium Zirconium Cyclosilicate
Syneos HealthPatiromer
AstraZenecaZirconium Cyclosilicate
AstraZenecaSodium Zirconium Cyclosilicate
AstraZenecaSodium Zirconium Cyclosilicate
Waterstone PharmaceuticalsWS016 3g
ArdelyxRDX013
Zeria Pharmaceuticalpatiromer
ArdelyxRDX227675
Medpacepatiromer

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 8,365 patients across 19 trials

NCT06365684AstraZenecaSodium zirconium cyclosilicate

Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4

Start: Apr 2024Est. completion: May 202516 patients
Phase 4Recruiting
NCT05535920AstraZenecaLOKELMA 5 GM Powder for Oral Suspension

A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia

Start: Apr 2022Est. completion: Apr 202488 patients
Phase 4Completed

A Two-Part, Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia

Start: Dec 2024Est. completion: Nov 2026420 patients
Phase 3Recruiting
NCT03528681AstraZenecaSodium Zirconium Cyclosilicate 5g

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.

Start: May 2021Est. completion: Sep 2022270 patients
Phase 3Completed
NCT04847232AstraZenecaSodium Zirconium Cyclosilicate

Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

Start: Apr 2021Est. completion: Mar 20242,690 patients
Phase 3Terminated
NCT04217590AstraZenecaSodium Zirconium Cyclosilicate

Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects

Start: Nov 2020Est. completion: Jan 2022134 patients
Phase 3Completed

Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

Start: Apr 2019Est. completion: Sep 20211,195 patients
Phase 3Completed
NCT03172702AstraZenecaZirconium Cyclosilicate

Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

Start: Sep 2017Est. completion: Jul 2019150 patients
Phase 3Completed
NCT02875834AstraZenecaSodium Zirconium Cyclosilicate

A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia

Start: Mar 2017Est. completion: Feb 2018267 patients
Phase 3Completed
NCT03127644AstraZenecaSodium Zirconium Cyclosilicate

ZS Ph2/3 Dose-response Study in Japan

Start: Jun 2017Est. completion: Feb 2018103 patients
Phase 2/3Completed

A Study to Evaluate the Safety and Efficacy of WS016 in Patients With Hyperkalemia.

Start: Sep 2023Est. completion: Aug 2024140 patients
Phase 2Unknown

A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia

Start: Jan 2021Est. completion: Mar 2022109 patients
Phase 2Completed

Exploratory Study of ZG-801 for the Treatment of Hyperkalemia

Start: Feb 2019Est. completion: Feb 2021184 patients
Phase 2Completed

A Study Evaluating the Onset-of-Action, Safety, and Efficacy of RDX227675 for the Treatment of Hyperkalemia

Start: Jan 2017Est. completion: May 201760 patients
Phase 2Terminated

Evaluation of Patiromer in Heart Failure Patients

Start: Apr 2009Est. completion: Dec 2009120 patients
Phase 2Completed

The Safety and Tolerability of WS016 in Healthy Chinese Volunteers

Start: Feb 2023Est. completion: Jun 202366 patients
Phase 1Completed
NCT03283267AstraZenecaSodium Zirconium Cyclosilicate

A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)

Start: Oct 2017Est. completion: Nov 201722 patients
Phase 1Completed
NCT06884267AstraZenecastandard hyperkalemia management implementation

Hyperkalemia Quality Improvement Program (HK-QIP) Study

Start: Jun 2025Est. completion: Nov 20271,000 patients
N/ARecruiting
NCT05408039AstraZenecaTracking Treatment Pathways in Adult Patients With Hyperkalemia.

Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

Start: Jul 2022Est. completion: Dec 20241,331 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

7 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 8,365 patients
6 companies competing in this space

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.