sodium valproate

Phase 3Small molecule

AstraZeneca

sodium valproate is one of 245 small molecule programs targeting Tics. It is currently in Phase 3.

Indications

Total Trials

Active Trials

244

Competitors

Pipeline

Status by Indication[3][1]

Indication

TicsRecruiting

Metastatic Colorectal CancerRecruiting

EpilepsyActive, not recruiting

Heart FailureRecruiting

Bipolar DisorderActive, not recruiting

Chronic Kidney DiseasesRecruiting

IntravenousActive, not recruiting

HyperkalaemiaRecruiting

CKD Stage 3Recruiting

Dialysis PatientsTerminated

TicsPhase 3

Recruiting

Metastatic Colorectal CancerPhase 2

Recruiting

EpilepsyPreclinical

Active, not recruiting

Heart FailurePhase 3

Recruiting

Bipolar DisorderPreclinical

Active, not recruiting

Chronic Kidney DiseasesPhase 3

Recruiting

IntravenousPhase 2

Active, not recruiting

HyperkalaemiaPhase 3

Recruiting

CKD Stage 3Phase 3

Recruiting

Dialysis PatientsPhase 3

Terminated

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

sodium valproate

AstraZeneca

Phase 3

3 2

Amidate

Pfizer

Preclinical

1 3

Savaysa

Xifaxan

2 5

Potassium Iodide

MMeda Pharmaceuticals

Preclinical

1 6

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 7

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

1 8

Statin

Bristol-Myers Squibb

Preclinical

1 9

Optimal Medical Therapy

HHelios Health Institute GmbH

Preclinical

2 10

Jardiance

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Heart Failure

NCT06578078

Post-ApprovalNot yet recruiting

Dialysis Patients

NCT06736184

Q2 2027

Phase 2Recruiting

Metastatic Colorectal Cancer

NCT05694936

Q3 2027

Phase 3Recruiting

Chronic Kidney Diseases

NCT06578533

Q1 2030

Phase 3Recruiting

Hyperkalaemia

NCT03813407

Clinical

Trials by Indication[1]

Hyperkalemia8 trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02875834·267 enrolled

Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.

Completed·ZZS Pharma, Inc.·Phase 3·NCT02107092·123 enrolled

Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy

Completed·GGuangdong Provincial People's Hospital·Phase 3·NCT05382988·62 enrolled

Show 5 more trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03528681·270 enrolled

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

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT04847232·2,690 enrolled

SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients

Completed·—·N/A·NCT06029179·120 enrolled

Safety & Efficacy of Zirconium Silicate Dosed for 28 Days in Hyperkalemia.

Completed·ZZS Pharma, Inc.·Phase 3·NCT02088073·258 enrolled

Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)

Unknown status·—·Phase 1·NCT04727840·20 enrolled

Chronic Kidney Disease4 trials

A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT05056727·1,112 enrolled

Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia

Completed· AstraZeneca logo

AstraZeneca··NCT04566653·147 enrolled

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

Completed· AstraZeneca logo

AstraZeneca··NCT06185660·125 enrolled

Show 1 more trial

Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease

Terminated· AstraZeneca logo

AstraZeneca·Phase 3·NCT04727528·39 enrolled

Heart Failure3 trials

Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure

Terminated· AstraZeneca logo

AstraZeneca·Phase 2·NCT03532009·182 enrolled

OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure

Active, not recruiting·MMichael Fu·Phase 2·NCT04789239·110 enrolled

A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients

Recruiting·FFundación para la Investigación del Hospital Clínico de Valencia·Phase 3·NCT06578078·94 enrolled

Epilepsy3 trials

Levetiracetam Versus Valproate in Idiopathic Generalized Epilepsy

Completed·MMazandaran University of Medical Sciences··NCT06393309·169 enrolled

Hormone Profiles in Adults With Newly Diagnosed Epilepsy

Unknown status·—·Phase 4·NCT00137709·80 enrolled

Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study

Not yet recruiting·—·Phase 4·NCT05881928·50 enrolled

Treatment2 trials

A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT03337477·70 enrolled

Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania

Completed·—·Phase 2·NCT00206778·36 enrolled

28 more indications

Hyperkalaemia2 trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT04217590·134 enrolled

An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT03813407·140 enrolled

Dialysis Patients2 trials

The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients

Not yet recruiting·QQianfoshan Hospital·Phase 4·NCT06736184·100 enrolled

Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

Terminated· AstraZeneca logo

AstraZeneca·Phase 4·NCT04997161·3 enrolled

Status Epilepticus2 trials

Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus

Completed·—·Phase 2·NCT02920060·80 enrolled

Efficacy Study of Intravenous Sodium Valproate in Addition to First Line Anti Epileptic Treatment of Generalized Convulsive Status Epilepticus.

Completed·AAssistance Publique - Hôpitaux de Paris·N/A·NCT01791868·245 enrolled

Bipolar Disorder2 trials

To Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder.

Unknown status·SShanghai Jiao Tong University School of Medicine·N/A·NCT00742638·70 enrolled

Drug Treatment for Alcoholics With Bipolar Disorder

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00000439·72 enrolled

Intravenous1 trial

Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement

Active, not recruiting·TTanta University·Phase 2·NCT07487675·10 enrolled

Rubinstein-Taybi Syndrome1 trial

Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial

Completed·UUniversity Hospital, Bordeaux·Phase 2·NCT01619644·41 enrolled

Asthma1 trial

Study of Efficacy of Sodium Valproate in Therapy of Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00153270·46 enrolled

Ischemic stroke1 trial

Sodium Valproate in Patients With Acute Ischemic Stroke

Unknown status·RRenJi Hospital·Phase 2·NCT06020898·40 enrolled

MPA1 trial

Comparison of Potassium Binders in the ER

Terminated·UUniversity of California, Irvine·Phase 4·NCT04585542·37 enrolled

Efficacy and Safety1 trial

Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT04676646·366 enrolled

Tacrolimus1 trial

Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT04788641·62 enrolled

CKD Stage 31 trial

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

Recruiting·LLeiden University Medical Center·Phase 4·NCT06365684·16 enrolled

Safety and Efficacy1 trial

Open-label Safety and Efficacy of Sodium Zirconium Cyclosilicate for up to 12 Months

Completed·ZZS Pharma, Inc.·Phase 3·NCT02163499·751 enrolled

AIN1 trial

Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

Completed· Roche logo

Roche··NCT00870688·82 enrolled

Neuropathic Pain1 trial

Efficacy of Valproate in Peripheral Neuropathic Pain

Terminated·UUniversity Hospital, Bordeaux·Phase 2/3·NCT00221637·40 enrolled

Cognition1 trial

Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate

Completed· Eisai logo

Eisai·Phase 4·NCT00713622·2 enrolled

Excretion1 trial

Study of Excretion Balance and Pharmacokinetics of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects

Completed· Sanofi logo

Sanofi·Phase 1·NCT03681158·5 enrolled

Randomized1 trial

Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012

Withdrawn·CCenters for Disease Control and Prevention·Phase 2·NCT01730313

Migraine1 trial

Efficacy of Pregabalin in Migraine Prevention

Withdrawn·—·Phase 3·NCT00447369·70 enrolled

Hemophilia1 trial

Combination Regimen With Sodium Valproate for Severe Hemophilia: a Single-arm, Phase 1, Pilot Trial.

Unknown status·XXue-chun Lu·Phase 1/2·NCT05920512·10 enrolled

Prolonged1 trial

Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets

Completed· Roche logo

Roche·Phase 1·NCT06214130·22 enrolled

Amyotrophic Lateral Sclerosis1 trial

Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis

Completed·UUMC Utrecht·Phase 3·NCT00136110·165 enrolled

Tics1 trial

Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate

Recruiting·TThe First Affiliated Hospital of University of South China·Phase 4·NCT07046676·312 enrolled

Metastatic Colorectal Cancer1 trial

Combining Sodium Valproate With Standard-of-care EGFR (Epidermal Growth Factor Receptor) Monoclonal Antibody Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·AAustralasian Gastro-Intestinal Trials Group·Phase 2·NCT05694936·90 enrolled

Monotherapy1 trial

Seroquel in Acute Mania: Study to Investigate if Valproate Add-On Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients

Terminated· AstraZeneca logo

AstraZeneca·Phase 4·NCT00139074·17 enrolled

Chronic Kidney Diseases1 trial

Phase III, Multicenter, Open-label, Randomized Clinical Trial to Evaluate Efficacy of Sodium Zirconium Cyclosilicate (Lokelma) Compared to Standard of Care to Manage Hyperkalemia in Patients With Chronic Kidney Disease (CKD)

Recruiting·FFundación para la Investigación del Hospital Clínico de Valencia·Phase 3·NCT06578533·78 enrolled

Cardiac Valve Disease1 trial

A Randomised Controlled Trial of Pre-surgery Sodium ValpRoate, for the Prevention of Organ Injury in Cardiac Surgery: THE Val-CARD TRIAL

Terminated·UUniversity of Leicester·Preclinical·NCT03825250·45 enrolled

Unspecified7 trials

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT05347693·186 enrolled

The ORTIZ Study: Optimising RASi Therapy With SZC

Terminated·BBarts & The London NHS Trust·Phase 2·NCT04983979·18 enrolled

ZS Ph2/3 Dose-response Study in Japan

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT03127644·103 enrolled

Show 4 more trials

A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03303521·196 enrolled

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

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03283267·22 enrolled

Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects.

Completed· Roche logo

Roche·Phase 1·NCT06211283·28 enrolled

Sodium Valproate for GSDV

Completed·UUniversity College, London·Phase 2·NCT03112889·8 enrolled

Sources

References

[1]
ClinicalTrials.gov — 58 trial records for sodium valproate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sodium valproate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sodium valproate. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

sodium valproate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q1 2030

Trials by Indication[1]

Hyperkalemia8 trials

Chronic Kidney Disease4 trials

Heart Failure3 trials

Epilepsy3 trials

Treatment2 trials

Hyperkalaemia2 trials

Dialysis Patients2 trials

Status Epilepticus2 trials

Bipolar Disorder2 trials

Intravenous1 trial

Rubinstein-Taybi Syndrome1 trial

Asthma1 trial

Ischemic stroke1 trial

MPA1 trial

Efficacy and Safety1 trial

Tacrolimus1 trial

CKD Stage 31 trial

Safety and Efficacy1 trial

AIN1 trial

Neuropathic Pain1 trial

Cognition1 trial

Excretion1 trial

Randomized1 trial

Migraine1 trial

Hemophilia1 trial

Prolonged1 trial

Amyotrophic Lateral Sclerosis1 trial

Tics1 trial

Metastatic Colorectal Cancer1 trial

Monotherapy1 trial

Chronic Kidney Diseases1 trial

Cardiac Valve Disease1 trial

Unspecified7 trials

References

Drug Info

Quick Facts

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