HydroDIURIL

(Hydrochlorothiazide)

ApprovedSmall molecule

Hydrochlorothiazide is used to lower high blood pressure and reduce excess fluid buildup in the body caused by heart, kidney, or liver disease.[2] HydroDIURIL is currently approved and in use across 35 indications[4].[1]

HydroDIURIL is one of 708 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

150

Total Trials

Active Trials

707

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeApproved

Cirrhosis of LiverActive, not recruiting

Cutaneous PhotosensitivityApproved

Cardiovascular DiseaseActive, not recruiting

Vitamin D DeficiencyActive, not recruiting

Cardiac ArrhythmiaActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

AlbuminuriaActive, not recruiting

Essential HypertensionActive, not recruiting

Cerebral Small Vessel DiseaseActive, not recruiting

Metabolic SyndromeApproved

Approved

Cirrhosis of LiverApproved

Active, not recruiting

Cutaneous PhotosensitivityApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Vitamin D DeficiencyPhase 2

Active, not recruiting

Cardiac ArrhythmiaApproved

Active, not recruiting

Left Ventricular HypertrophyPhase 3

Active, not recruiting

AlbuminuriaPhase 2

Active, not recruiting

Essential HypertensionApproved

Active, not recruiting

Cerebral Small Vessel DiseaseApproved

Active, not recruiting

Showing 10 of 34 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

HydroDIURIL

AbbVie

Approved

5 2

NOVOLIN R

Novo Nordisk

Preclinical

5 3

Glargine

Eli Lilly

Preclinical

8 4

Lovaza

AstraZeneca

Preclinical

1 5

Sulfonylureas

Eli Lilly

Preclinical

1 6

SGLT-2 Inhibitor

SSheffield Teaching Hospitals NHS Foundation Trust

Preclinical

2 7

Henagliflozin

TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Preclinical

1 8

Blank Control

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Preclinical

1 9

Routine Treatment

GSK

Preclinical

1 10

Dipeptidyl Peptidase-4 Inhibitors

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Obesity, Morbid

NCT03476551

Q2 2027

Phase 2Recruiting

Kidney Stone

NCT06111885

Q3 2027

Recruiting

Infants

NCT03511118

Q4 2027

Phase 1Active, not recruiting

Pain Management

NCT04676399

Clinical

Trials by Indication[1]

Hypertension35 trials

An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00185068·110 enrolled

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Effect of Aliskiren and Hydrochlorothiazide on Kidney Oxygenation in Patients With Hypertension

Completed·—·Phase 4·NCT01519635·24 enrolled

Show 32 more trials

Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

Completed· Novartis logo

Novartis·Phase 4·NCT00760266·451 enrolled

Treatment of Hypertension in Tibetan Adult Population

Unknown status·WWest China Hospital·Phase 4·NCT02217852·800 enrolled

Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension

Completed·IInVasc Therapeutics, Inc.·N/A·NCT00999752·40 enrolled

Behavioural Treatment of Hypertension

Completed·UUniversity of British Columbia·N/A·NCT00247910·150 enrolled

Olmesartan as an add-on to Amlodipine in Hypertension

Completed·SSankyo Pharma Gmbh·Phase 3·NCT00220233·632 enrolled

Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00765947·256 enrolled

A Study in People With Mild Hypertension

Completed· Eli Lilly logo

Eli Lilly·Phase 2·NCT00374855·153 enrolled

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension

Completed· Novartis logo

Novartis·Phase 2·NCT01692301·454 enrolled

Treatment of OSA Associated Hypertension With Alpha 2 Agonist or Diuretic

Completed·UUniversity of California, San Diego·Phase 4·NCT02699125·41 enrolled

Efficacy of Irbesartan/Hydrochlorothiazide Versus Valsartan/Hydrochlorothiazide in Mild to Moderate Hypertension

Completed· Sanofi logo

Sanofi·Phase 4·NCT00500604·1,617 enrolled

Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT00649389·2,500 enrolled

Candesartan Effect in Second Stage Arterial Hypertension

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00621153·214 enrolled

N-of-1 Trials In Children With Hypertension

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03461003·49 enrolled

Treatment of Adiposity Related hypErTension (TARGET)

Completed·UUMC Utrecht·Phase 4·NCT01138423·32 enrolled

A Study to Investigate the Magnitude and Duration of Response of MK0954 Compared to Placebo in Patients With Hypertension (0954-021)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00886600·122 enrolled

Efficacy and Safety of the Angiotensin II Receptor Antagonist Micardis® (Telmisartan) or Hydrochlorothiazide in the Management of Patients With Isolated Systolic Hypertension (ISH)

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02175355·1,039 enrolled

RAS Peptide Profiles in Patients With Arterial Hypertension

Completed·IInsel Gruppe AG, University Hospital Bern··NCT02449811·107 enrolled

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Telmisartan 80mg Plus Hydrochlorothiazide 25mg First Line in Moderate or Severe Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT00926289·894 enrolled

Vascular Dysfunction in Human Obesity Hypertension

Terminated·GGary L. Pierce·Phase 2·NCT01983462·33 enrolled

Diuretics, Hypertension, and Arrhythmias Clinical Trial

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

Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00171054·125 enrolled

Efficacy and Safety of Chronic Administration of Telmisartan as Monotherapy or in Combination With Hydrochlorothiazide or Other Antihypertensive Medications in Patients With Mild to Moderate Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT02177422·489 enrolled

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00797862·1,254 enrolled

Treatment of OSA Associated Hypertension With Nebivolol or Hydrochlorothiazide

Completed·UUniversity of California, San Diego·Phase 4·NCT02710071·41 enrolled

A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01658657·17 enrolled

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00523744·257 enrolled

Safety and Effect Study of SHR0532 (Drug Code) Tablets in Patients With Mild Hypertension

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT03971929·36 enrolled

A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01370655·46 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 and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00765674·1,191 enrolled

Efficacy of Candesartan on Reducing Blood Pressure in Insulin-Resistant, Obese Patients With Hypertension.

Completed· Takeda logo

Takeda·Phase 4·NCT00775814·188 enrolled

Hypertensive10 trials

Pharmacogenomic Evaluation of Antihypertensive Responses

Completed·UUniversity of Florida·Phase 4·NCT00246519·1,701 enrolled

Hypertensive Ambulatory Trial to Compare the Efficacy of HCTZ and Lisinopril

Completed·SScripps Translational Science Institute·N/A·NCT01258764·2 enrolled

Peripheral Vascular Effects of Sulfhydryl-containing Antihypertensive Pharmacotherapy on Microvessels in Humans

Terminated·PPenn State University·Phase 1/2·NCT03179163·10 enrolled

Show 7 more trials

Nijmegen Antihypertensive Management Improvement Study

Completed·RRadboud University Medical Center·Phase 4·NCT00457483·120 enrolled

Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02172586·363 enrolled

Evaluating the Effect of Aliskiren Versus HCTZ on Coronary Flow Reserve in Hypertensive Type II Diabetics

Withdrawn·CCorewell Health East·Phase 4·NCT00994253

Aliskiren vs Hydrochlorothiazide in Hypertensive Type II Diabetic Patients on Resistance Arteries

Withdrawn·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2·NCT01480791

Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population

Completed·TThe George Institute for Global Health, China·N/A·NCT02255253·1,410 enrolled

Genetic Epidemiology of Responses to Antihypertensives

Completed·MMayo Clinic··NCT00005520·1,200 enrolled

A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy

Completed· Novartis logo

Novartis·Phase 3·NCT00327145·894 enrolled

Essential Hypertension7 trials

A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Completed· Novartis logo

Novartis·Phase 3·NCT00311740·582 enrolled

Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.

Completed· Takeda logo

Takeda·Phase 2/3·NCT02072330·353 enrolled

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00667719·564 enrolled

Show 4 more trials

Series of N-of-1 Crossover Trials of Antihypertensive Therapy in Adolescents With Essential Hypertension

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02412761·42 enrolled

A Study on Molecular Genetics of Drug Responsiveness in Essential Hypertension

Completed·HHelsinki University Central Hospital·Phase 4·NCT03276598·233 enrolled

3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00153049·583 enrolled

A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 2·NCT01256411·341 enrolled

Interaction6 trials

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)

Completed·—·N/A·NCT01767298·24 enrolled

A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT03889145·30 enrolled

Drug Interaction Between Irbesartan and Hydrochlorothiazide

Completed·—·N/A·NCT01858610·18 enrolled

Show 3 more trials

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

Completed· Sanofi logo

Sanofi·Phase 1·NCT03387657·16 enrolled

Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide

Completed·—·N/A·NCT01767259·24 enrolled

Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide

Completed·—·N/A·NCT01858623·18 enrolled

Type 2 Diabetes5 trials

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

Unknown status·HHospital de Clinicas de Porto Alegre··NCT00935805·124 enrolled

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

Pharmacodynamics and Pharmacokinetics of Empagliflozin and Torasemide in Patients With Type 2 Diabetes

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01276288·23 enrolled

Show 2 more trials

Effects of Dapagliflozin on Kidney Function (Glomerular Filtration Rate) in Subjects With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00976495·154 enrolled

Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.

Withdrawn·—·Phase 4·NCT03640221

52 more indications

Metabolic Syndrome5 trials

Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome

Completed· Novartis logo

Novartis·Phase 4·NCT00821574·144 enrolled

Metabolic Effects of Antihypertensive Drugs on People With Metabolic Syndrome (The MEAD Study)

Completed·UUniversity of Florida·Phase 4·NCT00887510·24 enrolled

Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00110422·400 enrolled

Show 2 more trials

Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00797316·532 enrolled

Aldosterone and the Metabolic Syndrome

Completed·VVanderbilt University Medical Center·Phase 1·NCT01103245·69 enrolled

Chronic Kidney Disease5 trials

The Role of Skin Sodium Accumulation in Chronic Kidney Disease

Recruiting·—·N/A·NCT07020104·60 enrolled

The Effect of Diuretics on Mineral and Bone Disorder in Chronic Kidney Disease Patients

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT03082742·52 enrolled

Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT02646397·508 enrolled

Show 2 more trials

DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease

Completed·EErasmus Medical Center·Phase 4·NCT02875886·28 enrolled

A New Application of Amiloride in the Treatment of Patient With Chronic Kidney Disease In Reducing Urinary PROtein

Completed·GGuangdong Provincial People's Hospital·Phase 4·NCT03170336·40 enrolled

Safety and Efficacy4 trials

18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00654745·207 enrolled

Aliskiren Study of Safety and Efficacy in Senior Hypertensives

Withdrawn· Novartis logo

Novartis·Phase 4·NCT01922141

A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

Completed· Novartis logo

Novartis·Phase 3·NCT00368277·901 enrolled

Show 1 more trial

Safety and Efficacy of Valsartan vs Atenolol and Hydrochlorothiazide Combination on Blood Flow in Hypertensive Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00396656·30 enrolled

Heart Failure3 trials

Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure

Completed·SSpanish Society of Internal Medicine·Phase 3·NCT01647932·232 enrolled

POcus INTERvention for Tailoring Diuretic Strategy in Acute Decompensated Heart Failure

Not yet recruiting·HHospital de Clinicas de Porto Alegre·Phase 2/3·NCT07469722·128 enrolled

Protocol of Diuretics Use in Congestive Therapy in Heart Failure

Completed·UUniversity Hospital, Clermont-Ferrand·Phase 4·NCT03892148·299 enrolled

Tics3 trials

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

Compare the Pharmacokinetics of TAH(80/10/12.5) Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT03032315·44 enrolled

Examining the Effect of Different Diuretics on Fluid Retention in Diabetics Treated With Rosiglitazone.

Completed· GSK logo

GSK·Phase 4·NCT00306696·388 enrolled

Trial3 trials

INTERVENCION Trial

Completed·PPrevencion·Phase 4·NCT02373163·166 enrolled

Add-on to Micamlo BP Trial

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT01975246·309 enrolled

EBMtrialcentral- Comparing Initial Diuretic Therapies Using a Collaborative Network

Withdrawn·JJohns Hopkins University·Phase 4·NCT01748123

High Blood Pressure3 trials

An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00402103·556 enrolled

A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

Completed· Novartis logo

Novartis·Phase 3·NCT00386607·601 enrolled

A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00791258·999 enrolled

MPA3 trials

Chlorthalidone and HCTZ Impacts on Platelet Activation

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

A Study To Compare Effects Of GSK189075 In Combination With Either Furosemide Or Hydrochlorothiazide

Completed· GSK logo

GSK·Phase 1·NCT00671424·48 enrolled

Diuretic Comparison Project

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

Efficacy and Safety2 trials

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/25 mg in Comparison With Individual Components and Placebo

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00434967·2,207 enrolled

Antihypertensive Efficacy and Safety of Candesartan/HCT 32/12.5 and 32/25 mg in Comparison With Candesartan 32 mg

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00383929·1,979 enrolled

Oral2 trials

A Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Fimasartan and Hydrochlorothiazide in Healthy Male Volunteers

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 1·NCT00923533·34 enrolled

Relative Oral Bioavailability of Telmisartan / Hydrochlorothiazide (HCTZ) Fixed Dose Combination (FDC) Compared With Its Monocomponents in Healthy Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02187523·32 enrolled

Hypercalciuria2 trials

Dose-Dependent Effect of Thiazide in Dent's Disease Hypercalciuria

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT00638482·10 enrolled

Comparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria

Unknown status·HHospital Infantil de Mexico Federico Gomez·N/A·NCT03951558·90 enrolled

Clinical Trial2 trials

Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers

Completed· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 1·NCT02739672·40 enrolled

A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide

Completed· Boryung Pharmaceutical Co., Ltd logo

Boryung Pharmaceutical Co., Ltd·Phase 2·NCT02222480·103 enrolled

Blood Pressure2 trials

N-of-1 Trials for Blood Pressure Medications in Adults

Completed·—·Phase 1·NCT02744456·10 enrolled

Multi-Omics to Predict the Blood Pressure Response to Antihypertensives

Recruiting·RRadboud University Medical Center·Phase 4·NCT05917275·96 enrolled

Diabetes Mellitus2 trials

Aldosterone and Vascular Disease in Diabetes Mellitus

Completed·—·N/A·NCT00214825·46 enrolled

Aliskiren HCTZ Compared to Amlodipine in Patients With Stage 2 Systolic Hypertension and Diabetes Mellitus

Completed· Novartis logo

Novartis·Phase 4·NCT00787605·860 enrolled

Dapagliflozin2 trials

Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

Unknown status·MMedical University of Vienna·Phase 4·NCT05443932·32 enrolled

Dapagliflozin Effect on Erythropoiesis and Physical Fitness

Withdrawn·UUniversity Hospital Tuebingen·Phase 4·NCT03423355

ART2 trials

Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)

Completed·OOrganon and Co·Phase 1·NCT00953680·77 enrolled

Influence of Food on the Bioavailability of Two Doses of Telmisartan/HCTZ Fixed-dose Combination in Japanese Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02276378·32 enrolled

Kidney Stone2 trials

Hydrochlorothiazide for Kidney Stone Recurrence Prevention

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT03057431·416 enrolled

Indapamide and Chlorthalidone to Reduce Urine Supersaturation for Kidney Stone Prevention

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

Overweight1 trial

VALENCE: Valsartan Versus Atenolol on Exercise Capacity in Hypertensive Overweight Postmenopausal Women

Completed· Novartis logo

Novartis·Phase 4·NCT00171132·64 enrolled

Anxiety1 trial

Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System

Terminated·UUniversity of Iowa·Phase 4·NCT03109795·35 enrolled

Children1 trial

Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age

Completed· Novartis logo

Novartis·Phase 3·NCT01365481·150 enrolled

SMA1 trial

Effect of Licorice and Hydrochlorothiazide on Plasma Potassium

Completed·UUniversity of Oulu·Phase 4·NCT00605202·10 enrolled

Atherosclerosis1 trial

Olmesartan Medoxomil in Atherosclerosis

Completed·SSankyo Pharma Gmbh·Phase 3·NCT00185185·165 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Dilation1 trial

Telmisartan, Amlodipine and Flow Mediated Dilation

Unknown status·JJohannes Gutenberg University Mainz·Phase 4·NCT01180205·576 enrolled

Pilot Study1 trial

Study to Evaluate the Influence of Hydrochlorothiazide on Dermal Photosensitivity and DNA Stability - a Pilot Study (HCTox Study)

Completed·UUniversität des Saarlandes·Phase 1·NCT04654312·30 enrolled

Double-blind1 trial

Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo

Completed·UUmeå University·Phase 2·NCT00282178·26 enrolled

Angiotensin Converting Enzyme1 trial

Reversal of an Unfavorable Effect of Hydrochlorothiazide Compared to Angiotensin Converting Enzyme Inhibitor on Serum Uric Acid and Oxypurines Levels by Estrogen-progestin Therapy in Hypertensive Postmenopausal Women.

Completed·AAnna Posadzy-Małaczyńska·Phase 4·NCT03921736·180 enrolled

Drug Repurposing1 trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Dihydropyridine Calcium Channel Blockers Versus Hydrochlorothiazide

Completed·—··NCT05125224·163,720 enrolled

Type 2 DM1 trial

A Comparison of Indapamide SR 1.5 mg With HCTZ 25 mg, in Combination With an ACE-inhibitor, in Patients With Mild to Moderate AHT and Type 2 DM

Completed·LLaborMed Pharma S.A.·Phase 4·NCT00980187·56 enrolled

Cerebral Small Vessel Disease1 trial

Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients

Unknown status·YYining Huang·Phase 4·NCT01819441·1,200 enrolled

Left Ventricular Hypertrophy1 trial

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

Completed· Novartis logo

Novartis·Phase 3·NCT00446563·90 enrolled

Regression1 trial

Regression of Fatty Heart by Valsartan Therapy

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00745953

Cognitive Function1 trial

The Antihypertensives and Vascular, Endothelial and Cognitive Function Trial

Completed·UUniversity of Southern California·Phase 2·NCT00605072·53 enrolled

Renal insufficiency1 trial

Indapamide Versus Hydrochlorothiazide in Elderly Hypertensive Patients With Renal Insufficiency

Completed·WWest China Hospital·Phase 4·NCT01172431·240 enrolled

Skin Cancer1 trial

Hydrochlorothiazide and Risk of Skin Cancer

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT04334824·2,953,748 enrolled

Humans1 trial

Sympathetic Regulation of Large Artery Stiffness in Humans With ISH

Completed·UUniversity of Iowa·Phase 1·NCT04423627·100 enrolled

Pain Management1 trial

Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 1·NCT04676399·36 enrolled

Prevention1 trial

Use of Nanotechnology Structured Water for the Prevention of Recurrent Stone Formation

Completed·AALI KAMAL M. SAMI·N/A·NCT06681116·325 enrolled

Endothelial Function1 trial

Chlorthalidone Compared to Hydrochlorothiazide on Endothelial Function

Withdrawn·—·Phase 4·NCT01822860

Empagliflozin1 trial

Empagliflozin and Sympathetic Nerve Traffic

Completed·PProfil Institut für Stoffwechselforschung GmbH·Phase 4·NCT03254849·75 enrolled

Vitamin D Deficiency1 trial

Efficacy of the Dose Regimen of Oral Vitamin D 50,000 IU in the Treatment of Vitamin D Deficiency

Unknown status·UUnknown Sponsor·Phase 2·NCT02192229·80 enrolled

Type 2 Diabetic Patients1 trial

Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy

Unknown status·UUniversity of Pisa·Phase 4·NCT04242758·30 enrolled

Albuminuria1 trial

To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy

Terminated· Novartis logo

Novartis·Phase 2·NCT01302899·8 enrolled

Hypernatremia1 trial

Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients

Unknown status·UUniversity of Sao Paulo·Phase 2·NCT03658850·184 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00776646·36 enrolled

Homeostasis1 trial

Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00871871·64 enrolled

Biomarkers1 trial

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Completed· Novartis logo

Novartis·Phase 4·NCT01176032·74 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

Terminated· Novartis logo

Novartis·Phase 3·NCT01259297·2,336 enrolled

Polycystic Kidney Disease1 trial

HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

Recruiting·UUniversity Medical Center Groningen·Phase 3·NCT05373264·300 enrolled

Completed·PParc de Salut Mar·Phase 1·NCT04197622·3 enrolled

A Translational Approach to Gitelman Syndrome

Completed·OOregon Health and Science University·N/A·NCT00822107·8 enrolled

Factorial Study of Metoprolol Succinate TOPROL-XL (324A)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00642096·1,900 enrolled

Show 3 more trials

Salt Loading and Thiazide Intervention Study

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00896389·124 enrolled

Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim··NCT01050062·1,452 enrolled

Fasting Study of Hydrochlorothiazide Tablets 50 mg to Hydrochlorothiazide Tablets 50 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649324·40 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ESIDRIX

NDA NDA011793

Jan 1, 1982

HYDRODIURIL

NDA NDA011835

Jan 1, 1982

ORETIC

NDA NDA011971

Dec 27, 1996

MICROZIDE

NDA NDA020504

Jan 28, 2025

INZIRQO

NDA NDA219141

Sources

References

[1]
ClinicalTrials.gov — 150 trial records for Hydrochlorothiazide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — HydroDIURIL drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Hydrochlorothiazide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Hydrochlorothiazide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219141). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for HydroDIURIL. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie 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: AbbVie

Patent Landscape[6]

Patent Cliff

Jan 23, 2044

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11878022Jan 23, 2044

HydroDIURIL

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Hypertension35 trials

Hypertensive10 trials

Essential Hypertension7 trials

Interaction6 trials

Type 2 Diabetes5 trials

Metabolic Syndrome5 trials

Chronic Kidney Disease5 trials

Safety and Efficacy4 trials

Heart Failure3 trials

Tics3 trials

Trial3 trials

High Blood Pressure3 trials

MPA3 trials

Efficacy and Safety2 trials

Oral2 trials

Hypercalciuria2 trials

Clinical Trial2 trials

Blood Pressure2 trials

Diabetes Mellitus2 trials

Dapagliflozin2 trials

ART2 trials

Kidney Stone2 trials

Overweight1 trial

Anxiety1 trial

Children1 trial

SMA1 trial

Atherosclerosis1 trial

Infants1 trial

Dilation1 trial

Pilot Study1 trial

Double-blind1 trial

Angiotensin Converting Enzyme1 trial

Drug Repurposing1 trial

Type 2 DM1 trial

Cerebral Small Vessel Disease1 trial

Left Ventricular Hypertrophy1 trial

Regression1 trial

Cognitive Function1 trial

Renal insufficiency1 trial

Skin Cancer1 trial

Humans1 trial

Pain Management1 trial

Prevention1 trial

Endothelial Function1 trial

Empagliflozin1 trial

Vitamin D Deficiency1 trial

Type 2 Diabetic Patients1 trial

Albuminuria1 trial

Hypernatremia1 trial

Fasting Conditions1 trial

Homeostasis1 trial

Biomarkers1 trial

Randomized Controlled Trial1 trial

Polycystic Kidney Disease1 trial

Obesity, Morbid1 trial

Preeclampsia1 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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