Thalitone

(Chlorthalidone)

ApprovedSmall molecule

Chlorthalidone is used to treat high blood pressure and to remove excess fluid from the body in people with heart or kidney problems.[2] Thalitone is currently approved and in use across 12 indications[4].[1]

Thalitone is one of 289 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

288

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Liver TransplantActive, not recruiting

StrokeActive, not recruiting

GlomerulonephritisActive, not recruiting

Angina PectorisActive, not recruiting

Nephrotic SyndromeActive, not recruiting

Congestive Heart FailureActive, not recruiting

Diabetes MellitusActive, not recruiting

HypertensionCompleted

Kidney StonesRecruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Liver TransplantApproved

Active, not recruiting

StrokeApproved

Active, not recruiting

GlomerulonephritisApproved

Active, not recruiting

Angina PectorisApproved

Active, not recruiting

Nephrotic SyndromeApproved

Active, not recruiting

Congestive Heart FailureApproved

Active, not recruiting

Diabetes MellitusApproved

Active, not recruiting

HypertensionApproved

Completed

Kidney StonesApproved

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

160 competitors in Hypertension

#DrugCompanyPhaseTrials

Thalitone

Jazz Pharmaceuticals

Approved

18 2

Foundayo

Eli Lilly

Phase 3

3 3

Nitrostat

VViatris Specialty LLC

Phase 3

5 4

Alka-Seltzer

AAbbott

Phase 3

1 5

SGLT2

PProf. Dr. med. Ingo Eitel

Phase 3

1 6

Avastin

Roche

Preclinical

1 7

Winrevair

Alphagan

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 10

Disalcid

JJoslin Diabetes Center

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Kidney Stone

NCT06111885

Q4 2027

Post-ApprovalRecruiting

Hypertension

NCT05593055

ApprovedRecruiting

Kidney Stones

NCT07225764

Q1 2029

Phase 2Recruiting

Hypertension

NCT07238400

Clinical

Trials by Indication[1]

Hypertension18 trials

Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension

Recruiting·—·Phase 4·NCT05593055·75 enrolled

Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000499

Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension.

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT06287580·27 enrolled

Show 15 more trials

Uric Acid and Hypertension in African Americans

Completed·UUniversity of Florida·Phase 3·NCT00241839·150 enrolled

Systolic Hypertension in the Elderly Program (SHEP)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000514

Resistant Arterial Hypertension Cohort Study

Completed·UUniversity Hospital, Geneva··NCT01083017·74 enrolled

Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Completed·AAnthony J Viera, MD, MPH·N/A·NCT02121041·28 enrolled

Treatment of Mild Hypertension Study (TOMHS)

Completed·UUniversity of Minnesota·Phase 2·NCT00000522

Study to Evaluate the Efficacy and Safety of the Combination of Valturna and Amlodipine or Valturna and Chlorthalidone Versus Valturna Alone in Patients With Stage 2 Hypertension and Diabetes

Terminated· Novartis logo

Novartis·Phase 4·NCT01368536·975 enrolled

Hypertension Screening and Treatment Program

Completed·UUS Department of Veterans Affairs··NCT00007592

Genetics of Hypertension Associated Treatments (GenHAT)

Completed·DDonna Arnett, 257-5678··NCT00006294·37,939 enrolled

Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension

Completed· Takeda logo

Takeda·Phase 3·NCT00847626·1,711 enrolled

Diuretics, Hypertension, and Arrhythmias Clinical Trial

Completed·UUniversity of California, San Francisco·Phase 3·NCT00000525·233 enrolled

A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Completed·IIndiana University·Phase 4·NCT01750294·14 enrolled

Efficacy of Chlorthalidone and Hydrochlorothiazide Combined With Amiloride on Blood Pressure in Primary Hypertension.

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 3·NCT03928145·84 enrolled

Efficacy/Safety Study of Valsartan and Chlorthalidone Conjugate Treatment Compared to Simple Treatment for Hypertension

Completed·FFarma de Colombia SA·Phase 3·NCT01850160·124 enrolled

Mechanisms of Refractory Hypertension (Carvedilol)

Withdrawn·UUniversity of Alabama at Birmingham·N/A·NCT02357004

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy

Recruiting·MMassachusetts General Hospital·Phase 2·NCT07238400·90 enrolled

Hypertensive4 trials

Tissue Sodium in Pre-hypertensive Patients

Completed·VVanderbilt University·Phase 2·NCT02236520·71 enrolled

Trial of Antihypertensive Intervention Management

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000513

Pharmacogenomic Evaluation of Antihypertensive Responses 2

Completed·UUniversity of Florida·Phase 4·NCT01203852·839 enrolled

Show 1 more trial

Use of Impedance Cardiography and Applanation Tonometry for Prediction of the Antihypertensive Effect of Two Drugs

Completed·—·N/A·NCT03560804·60 enrolled

MPA3 trials

Chlorthalidone and HCTZ Impacts on Platelet Activation

Unknown status·—·Phase 4·NCT02100462·30 enrolled

PK Study of YH22162 FDC Compared to Combination of Twynsta and Hygroton

Completed·YYuhan Corporation·Phase 1·NCT02496910·180 enrolled

Diuretic Comparison Project

Completed·VVA Office of Research and Development·Phase 3·NCT02185417·20,723 enrolled

Chronic Kidney Disease2 trials

Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial

Completed·HHospital General de México Dr. Eduardo Liceaga·Phase 2·NCT03923933·34 enrolled

Chlorthalidone in Chronic Kidney Disease

Completed·IIndiana University·Phase 2·NCT02841280·160 enrolled

Kidney Transplant2 trials

Thiazide Diuretics for Hypertension in Kidney Transplant Recipients Using Tacrolimus

Completed·EErasmus Medical Center·Phase 3·NCT02644395·49 enrolled

The Management of Resistant Hypertension in Kidney Transplant Patients Using Chlorthalidone

Withdrawn·VVirginia Commonwealth University·Phase 4·NCT02030314

16 more indications

Interaction2 trials

Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)

Completed·YYuhan Corporation·Phase 1·NCT02152969·66 enrolled

Pharmacokinetic Interactions and Safety Study of Telmisartan and Chlorthalidone

Completed·HHanAll BioPharma Co., Ltd.·Phase 1·NCT01806363·60 enrolled

Dialysis Patients1 trial

Diuretic Use in Hemodialysis Patients With Residual Renal Function

Suspended·UUniversity of Alberta·Phase 4·NCT05915286·34 enrolled

Spironolactone1 trial

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Unknown status·IIndiana Institute for Medical Research·Phase 2·NCT05222191·24 enrolled

Liver Transplant1 trial

Mechanism of Hypertension Treatments in Liver Transplant Recipients (BLOCK LTR-HTN)

Withdrawn·NNorthwestern University·Phase 4·NCT05275907

Essential Hypertension1 trial

Efficacy and Safety of Azilsartan Medoxomil Co-Administered With Chlorthalidone in Participants With Essential Hypertension

Completed· Takeda logo

Takeda·Phase 3·NCT00591773·551 enrolled

Terminated·UUniversity of Rochester·Phase 2·NCT03325114·1 enrolled

Age1 trial

Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.

Completed·PParc de Salut Mar·Phase 1·NCT04757532·9 enrolled

Trial1 trial

EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network

Withdrawn·JJohns Hopkins University·Phase 4·NCT01748123

Endothelial Function1 trial

Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Withdrawn·—·Phase 4·NCT01822860

Fasting Conditions1 trial

Non-interaction Study of Chlorthalidone and Losartan in Fixed Combination, in Healthy Subjects, Under Fasting Conditions

Completed·LLaboratorios Silanes S.A. de C.V.·Phase 1·NCT05090449·36 enrolled

Kidney Stone1 trial

Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

Recruiting·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT06111885·99 enrolled

Tics1 trial

Night Time Use of Thiazide Diuretics for Improved Reduction in Stone Risk in Stone Formers With Elevated Urine Calcium

Completed·VVA New York Harbor Healthcare System·N/A·NCT02711670·10 enrolled

Metabolic Syndrome1 trial

Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity

Completed·BBrigham and Women's Hospital·Approved·NCT04519164·79 enrolled

Kidney Stones1 trial

Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial

Recruiting·IIcahn School of Medicine at Mount Sinai·Approved·NCT07225764·80 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

HYGROTON

NDA NDA012283

Dec 20, 1988

THALITONE

NDA NDA019574

Feb 12, 1992

THALITONE

NDA NDA019574

Oct 15, 1992

THALITONE

NDA NDA019574

Jun 26, 1993

THALITONE

NDA NDA019574

Apr 8, 1994

THALITONE

NDA NDA019574

Jun 27, 1994

THALITONE

NDA NDA019574

Oct 26, 1995

THALITONE

NDA NDA019574

Oct 23, 1997

THALITONE

NDA NDA019574

Mar 16, 1999

THALITONE

NDA NDA019574

Feb 11, 2000

THALITONE

NDA NDA019574

Jun 21, 2001

THALITONE

NDA NDA019574

Jun 1, 2004

THALITONE

NDA NDA019574

Apr 19, 2018

THALITONE

NDA NDA019574

Sep 17, 2019

THALITONE

NDA NDA019574

Mar 17, 2025

HEMICLOR

NDA NDA218647

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Chlorthalidone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Thalitone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Chlorthalidone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Chlorthalidone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218647). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Thalitone. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Thiazide-Sensitive Sodium-Chloride Cotransporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Sep 3, 2045

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12667554Sep 3, 2045

Thalitone

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2029

Trials by Indication[1]

Hypertension18 trials

Hypertensive4 trials

MPA3 trials

Chronic Kidney Disease2 trials

Kidney Transplant2 trials

Interaction2 trials

Dialysis Patients1 trial

Spironolactone1 trial

Liver Transplant1 trial

Essential Hypertension1 trial

Heart Attack1 trial

Side Effects1 trial

Type 1 Diabetes1 trial

Age1 trial

Trial1 trial

Endothelial Function1 trial

Fasting Conditions1 trial

Kidney Stone1 trial

Tics1 trial

Metabolic Syndrome1 trial

Kidney Stones1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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