Tekturna

(Aliskiren)

ApprovedSmall molecule

Aliskiren is used to treat high blood pressure. It helps relax blood vessels so blood can flow more easily, which lowers your blood pressure and reduces strain on your heart.[2] Tekturna is currently approved and in use across 34 indications[4].[1]

Tekturna is one of 672 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

131

Total Trials

Active Trials

671

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Vitamin D DeficiencyActive, not recruiting

Endothelial DysfunctionActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

AlbuminuriaActive, not recruiting

Essential HypertensionApproved

HyperuricemiaActive, not recruiting

Acute Coronary SyndromeActive, not recruiting

Coronary Artery DiseasePhase 3

Active, not recruiting

Metabolic SyndromeApproved

Active, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Vitamin D DeficiencyApproved

Active, not recruiting

Endothelial DysfunctionPhase 2

Active, not recruiting

Left Ventricular HypertrophyApproved

Active, not recruiting

AlbuminuriaApproved

Active, not recruiting

Essential HypertensionApproved

Approved

HyperuricemiaApproved

Active, not recruiting

Acute Coronary SyndromePhase 2

Active, not recruiting

Showing 10 of 34 indications

Competition

Competitive Landscape

885 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Tekturna

Tibotec Pharmaceuticals, Ireland

Approved

4 2

Byetta

AstraZeneca

Preclinical

55 3

Jardiance

Boehringer Ingelheim

Preclinical

31 4

NOVOLIN R

Novo Nordisk

Preclinical

5 5

Glargine

Eli Lilly

Preclinical

8 6

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 7

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 8

Cecon

MMcGuff Pharmaceuticals, Inc.

Preclinical

1 9

Aurlumyn

BBTG International Inc.

Preclinical

1 10

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

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

Timeline

Expected Milestones

Q4 2029

Phase 2Recruiting

C3 Glomerulopathy

NCT04183101

Clinical

Trials by Indication[1]

Hypertension22 trials

Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

Completed· Novartis logo

Novartis·Phase 1·NCT00933920·124 enrolled

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension

Terminated· Novartis logo

Novartis·Phase 2·NCT00498433·46 enrolled

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients With Hypertension Not Adequately Responding to Amlodipine Alone

Completed· Novartis logo

Novartis·Phase 3·NCT00778921·847 enrolled

Show 19 more trials

Blood Pressure Lowering of Aliskiren Hydrochlorothiazide (HCTZ) Versus Amlodipine in Stage 2 Hypertension in African Americans

Completed· Novartis logo

Novartis·Phase 4·NCT00739596·332 enrolled

Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00772577·386 enrolled

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

Completed·—·Phase 4·NCT01519635·24 enrolled

The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00856960·12 enrolled

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

Efficacy and Safety of Once Daily Dosing of Aliskiren (300 mg (qd) Once a Day) to Twice Daily Dosing of Aliskiren (150 mg (Bid) Twice a Day) in Treating Moderate Hypertension.

Completed· Novartis logo

Novartis·Phase 4·NCT00654875·328 enrolled

Treatment of Adiposity Related hypErTension (TARGET)

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

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00705575·688 enrolled

A Clinical Study to Compare the Safety and Efficacy of an Aliskiren-based Regimen With a Lisinopril Based Regimen in Patients With Severe Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00219050·180 enrolled

Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany

Completed·SStiftung Institut fuer Herzinfarktforschung··NCT01454583·15,337 enrolled

Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA's and Mild Hypertension

Terminated·AAmsterdam UMC, location VUmc·N/A·NCT01425242·3 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

Efficacy and Safety of Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Moderate-severe Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00765674·1,191 enrolled

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 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

Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00262236·693 enrolled

SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00299806·39 enrolled

8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT01570686·589 enrolled

Efficacy and Safety of Aliskiren in Patients With Mild to Moderate Hypertension During Exercise

Completed· Novartis logo

Novartis·Phase 2·NCT00819767·68 enrolled

Essential Hypertension10 trials

Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg

Completed· Novartis logo

Novartis·Phase 3·NCT00529451·1,613 enrolled

Efficacy and Safety of Aliskiren 300mg Compared to Irbesartan 300mg and Ramipril 10 mg in the Setting of a Missed Dose for Patients With Essential Hypertension.

Completed· Novartis logo

Novartis·Phase 3·NCT00343551·654 enrolled

A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

Completed· Novartis logo

Novartis·Phase 4·NCT00631917·774 enrolled

Show 7 more trials

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

Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00739973·2,694 enrolled

Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT01237223·1,342 enrolled

Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

Completed· Novartis logo

Novartis·Phase 3·NCT00706134·756 enrolled

Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00219037·1,955 enrolled

Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00344110·768 enrolled

Clinical Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Hydrochlorothiazide in Patients With Essential Hypertension.

Completed· Novartis logo

Novartis·Phase 3·NCT00219024·2,775 enrolled

Hypertensive9 trials

A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age

Completed· Novartis logo

Novartis·Phase 1/2·NCT00834041·39 enrolled

A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

Completed· Novartis logo

Novartis·Phase 3·NCT00219063·844 enrolled

A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

Completed· Novartis logo

Novartis·Phase 3·NCT00219115·493 enrolled

Show 6 more trials

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

Withdrawn·CCorewell Health East·Phase 4·NCT00994253

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

Completed· Novartis logo

Novartis·Phase 3·NCT01151410·208 enrolled

SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction

Completed· Novartis logo

Novartis·Phase 3·NCT00299832·40 enrolled

A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00219102·336 enrolled

Aliskiren or Amlodipine in Hypertensive Hemodialysed Patients

Unknown status·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT01394770·350 enrolled

Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients

Completed· Novartis logo

Novartis·Phase 4·NCT01042392·506 enrolled

Heart Failure8 trials

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT00853658·7,064 enrolled

Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure

Unknown status·TTaipei Veterans General Hospital, Taiwan·N/A·NCT01298258·120 enrolled

Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction

Completed·WWake Forest University Health Sciences·Phase 4·NCT00982033·52 enrolled

Show 5 more trials

"ALOFT - Aliskiren Observation of Heart Failure Treatment": Efficacy and Safety of Aliskiren Added on Top of Standard Therapy in Adults (≥ 18 Years) With Stable Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT00219011·280 enrolled

A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

Completed· Novartis logo

Novartis·Phase 2·NCT01125514·37 enrolled

Significance of Regional Ventriculo-arterial Coupling in Patients With Chronic Heart Failure

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01156207·120 enrolled

Six Months Efficacy and Safety of Aliskiren Therapy on Top of Standard Therapy, on Morbidity and Mortality in Patients With Acute Decompensated Heart Failure

Completed· Novartis logo

Novartis·Phase 3·NCT00894387·1,639 enrolled

Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

Terminated·UUniversity Medical Center Groningen·Phase 2·NCT00881439·41 enrolled

Safety and Efficacy6 trials

A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

Completed· Novartis logo

Novartis·Phase 3·NCT00219089·839 enrolled

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00219193·641 enrolled

Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

Completed· Novartis logo

Novartis·Phase 3·NCT01150357·267 enrolled

Show 3 more trials

Aliskiren Study of Safety and Efficacy in Senior Hypertensives

Withdrawn· Novartis logo

Novartis·Phase 4·NCT01922141

A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Amlodipine in Hypertensive Non Responders Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00219076·504 enrolled

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

50 more indications

High Blood Pressure6 trials

A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo in Patients With High Blood Pressure.

Completed· Novartis logo

Novartis·Phase 3·NCT00219128·671 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 Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00260923·641 enrolled

Show 3 more 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 Clinical Study to Assess Efficacy and Safety of Aliskiren in the Elderly With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00219167·355 enrolled

Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

Completed· Novartis logo

Novartis·Phase 3·NCT00219180·1,797 enrolled

Efficacy and Safety4 trials

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazide Based Treatment Regimen With Optional Addition of Amlodipine

Completed· Novartis logo

Novartis·Phase 3·NCT00294710·976 enrolled

A Clinical Study to Compare Long-term Efficacy and Safety of an Aliskiren Based Regimen to a Hydrochlorothiazidebased Treatment Regimen With Optional Addition of Amlodipine

Completed· Novartis logo

Novartis·Phase 3·NCT00219154·1,125 enrolled

Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

Completed· Novartis logo

Novartis·Phase 3·NCT00777946·818 enrolled

Show 1 more trial

Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

Completed· Novartis logo

Novartis·Phase 4·NCT00865020·822 enrolled

Type 2 Diabetes4 trials

Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes

Completed· Novartis logo

Novartis·Phase 1/2·NCT00461136·18 enrolled

Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)

Terminated· Novartis logo

Novartis·Phase 3·NCT00549757·8,606 enrolled

Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

Completed· Novartis logo

Novartis·Phase 2·NCT00097955·496 enrolled

Show 1 more trial

Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy

Completed· Novartis logo

Novartis·Phase 1/2·NCT00464776·26 enrolled

Diabetes Mellitus3 trials

Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus

Completed· Novartis logo

Novartis·Phase 4·NCT00927394·1,143 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

Aliskiren's Effect on Arterial Stiffness and Platelet Function in Patients With Diabetes Mellitus (DM)

Unknown status·—·N/A·NCT00732407·40 enrolled

Metabolic Syndrome3 trials

Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome

Terminated· Novartis logo

Novartis·Phase 4·NCT00542269·178 enrolled

Aldosterone and the Metabolic Syndrome

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

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

Completed· Novartis logo

Novartis·Phase 4·NCT00797316·532 enrolled

Endothelial Function3 trials

The Effect of Aliskiren on Endothelial Function in Pre-Diabetes and Diabetes

Completed·—·N/A·NCT01165983·124 enrolled

The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function

Completed·VVanderbilt University Medical Center·Phase 4·NCT03115853·31 enrolled

Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Terminated·UUniversity of Alabama at Birmingham·Phase 4·NCT01349114·21 enrolled

Blood Pressure3 trials

Comparison of Amlodipine and Aliskiren in Diabetic Hypertensive Patient With Blood Pressure Not Controlled by Losartan

Withdrawn·HHospital Universitario Pedro Ernesto·Phase 4·NCT01409408

Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

Completed· Novartis logo

Novartis·Phase 4·NCT00441064·132 enrolled

Evaluation of Aliskiren Efficacy by Different Methods of Blood Pressure Measurements

Terminated·MMeir Medical Center·Phase 4·NCT01060865·50 enrolled

Albuminuria2 trials

Shiga Microalbuminuria Reduction Trial-2

Completed·SShiga University·Phase 4·NCT01461499·237 enrolled

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

Terminated· Novartis logo

Novartis·Phase 2·NCT01302899·8 enrolled

Left Ventricular Hypertrophy2 trials

Aliskiren in Combination With Losartan Compared to Losartan on the Regression of Left Ventricular Hypertrophy in Overweight Patients With Essential Hypertension

Completed· Novartis logo

Novartis·Phase 3·NCT00219141·460 enrolled

Eplerenone and Aliskiren Research Targeting Hypertensive Patients With Left Ventricular Hypertrophy

Unknown status·NNagoya University·Phase 4·NCT01893788·100 enrolled

Chronic Kidney Disease2 trials

Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

Completed·JJichi Medical University·Phase 4·NCT01284114·23 enrolled

Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease

Completed·TThe University of Hong Kong·Phase 4·NCT01150201·80 enrolled

Biomarkers2 trials

Direct Renin Inhibition Effects on Atherosclerotic Biomarkers

Completed·TTexas Tech University Health Sciences Center·Phase 4·NCT00818779·38 enrolled

ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling

Completed· Novartis logo

Novartis·Phase 4·NCT01176032·74 enrolled

Kidney Transplant2 trials

Influence of Aliskiren on Albuminuria After Kidney Transplantation

Completed·MMedical University of Gdansk·N/A·NCT02446548·18 enrolled

Effect of Short Term Aliskiren Treatment in Kidney Transplant Patients

Terminated·—·Phase 4·NCT01437943·10 enrolled

Diabetic Macular Edema1 trial

Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Terminated· Novartis logo

Novartis·Phase 2·NCT00768040·39 enrolled

Congestive Heart Failure1 trial

Add-on Aliskiren Treatment in Patients With Chronic Congestive Heart Failure

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT01040494·60 enrolled

Dialysis Patients1 trial

RAAS Inhibitor Drugs in Dialysis Patients

Unknown status·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT01635387·350 enrolled

Combination Therapy1 trial

A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

Completed· Novartis logo

Novartis·Phase 4·NCT01056731·253 enrolled

Endothelial Dysfunction1 trial

Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome

Completed· Novartis logo

Novartis·Phase 2·NCT00417170·48 enrolled

Kidney1 trial

Direct Renin Inhibition and the Kidney

Completed·VVitae Pharmaceuticals, Inc.·Phase 1·NCT01217736·22 enrolled

Systolic Heart Failure1 trial

Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure

Completed· Novartis logo

Novartis·Phase 2·NCT00923156·123 enrolled

Cardiac Transplant1 trial

Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

Terminated·UUniversity of Colorado, Denver·Phase 4·NCT01235910·1 enrolled

Treatment1 trial

Aliskiren on Retinal Vasculature Treatment Study

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 3·NCT01318395·56 enrolled

Membranous Nephropathy1 trial

Aliskiren in Patients With Idiopathic Membranous Nephropathy

Withdrawn·MMayo Clinic·N/A·NCT01093781

Acute Coronary Syndrome1 trial

Efficacy and Safety of Aliskiren and Valsartan Versus Placebo in Patients Stabilized Following an Acute Coronary Syndrome

Completed· Novartis logo

Novartis·Phase 2·NCT00409578·1,101 enrolled

CLE1 trial

Aliskiren and Muscle Sympathetic Nerve Activity

Unknown status·UUMC Utrecht·Phase 4·NCT00719316·30 enrolled

IgA Nephropathy1 trial

A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Unknown status·KKagawa University·Phase 4·NCT01184599·30 enrolled

Atrial Fibrillation1 trial

Role of ALiskiren, a Direct Renin Inhibitor, in Preventing Atrial Fibrillation in Patients With a Pacemaker; RALF.

Unknown status·MMika Lehto·Phase 3·NCT02909166·70 enrolled

ESS1 trial

Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS

Completed·SSamsung Medical Center·Phase 3·NCT01715207·30 enrolled

C3 Glomerulopathy1 trial

Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy

Recruiting·RRegion Skane·Phase 2·NCT04183101·30 enrolled

Coronary Artery Disease1 trial

Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00853827·613 enrolled

Kidney Disease1 trial

Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease

Terminated·—·Phase 4·NCT01129557·46 enrolled

Diabetes1 trial

The Effect of Renin Inhibition on Nerve Function in Diabetes

Completed·CChristiana Care Health Services·N/A·NCT00935064·60 enrolled

Hyperuricemia1 trial

Non-Inferiority Study of Aliskiren vs Losartan in the Treatment of Hypertension With Hyperuricemia

Completed·—·Phase 4·NCT06718062·66 enrolled

Diabetic Nephropathy1 trial

Effects of Aliskiren, Irbesartan, and the Combination in Hypertensive Patients With Type 2 Diabetes and Diabetic Nephropathy

Completed· Novartis logo

Novartis·Phase 1/2·NCT00464880·24 enrolled

Type 2 Diabetes Mellitus1 trial

A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus

Completed· Novartis logo

Novartis·Phase 4·NCT00660309·45 enrolled

Medication1 trial

Bioavailability of Aliskiren and Valsartan Combined as a Single Tablet vs. the Same Medications Given Separately to Healthy Subjects.

Completed· Novartis logo

Novartis·Phase 1·NCT00416468·32 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

ALD1 trial

Triple Blockade of the Renin Angiotensin Aldosterone System in Diabetic (Type 1&2) Proteinuric Patients

Terminated·CCook County Health·Phase 4·NCT00961207·2 enrolled

Myocardial Infarction1 trial

Safety and Efficacy of Aliskiren in Post Myocardial Infarction Patients (ASPIRE)

Completed· Novartis logo

Novartis·Phase 3·NCT00414609·820 enrolled

Vitamin D Deficiency1 trial

Vitamin D Deficiency in Patients With Hypertension

Terminated·UUConn Health·Phase 4·NCT00974922·40 enrolled

Hemodynamic1 trial

Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

Completed· Novartis logo

Novartis·Phase 3·NCT00518765·32 enrolled

End-Stage Renal Disease1 trial

Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects

Completed· Novartis logo

Novartis·Phase 1·NCT01568775·12 enrolled

Drug1 trial

Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.

Completed· Novartis logo

Novartis·Phase 1·NCT00416728·32 enrolled

Nephropathy1 trial

Aliskiren for Immunoglobulin A (IgA) Nephropathy

Completed·—·Phase 3·NCT00870493·22 enrolled

Plaque1 trial

Aliskiren Effect on Aortic Plaque Progression

Terminated·OOhio State University·Phase 2/3·NCT01417104·71 enrolled

ART1 trial

RAS Quantification in Patients With Aliskiren or Candesartan

Completed·MMedical University of Vienna·Phase 4·NCT01827202·24 enrolled

Insulin Sensitivity1 trial

Assessment of Renin Inhibition on Insulin Sensitivity, Diastolic Function and Aortic Compliance

Terminated·—·N/A·NCT01252238·24 enrolled

Peritoneal Dialysis1 trial

The Effect of Aliskiren and Losartan on Peritoneal Membrane in Continuous Ambulatory Peritoneal Dialysis Patients

Unknown status·—·Phase 4·NCT01305850·100 enrolled

Atherosclerosis1 trial

The Effect of Tekturna on Endothelial Function and Endothelial Progenitor Cells in Patients With Early Atherosclerosis

Terminated·MMayo Clinic·Phase 3·NCT01067326·22 enrolled

IgAN1 trial

Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

Completed·TThe University of Hong Kong·Phase 4·NCT00922311·25 enrolled

Unspecified3 trials

SPP100 Dose Finding Study in Japan

Completed· Novartis logo

Novartis·Phase 2·NCT00311012·445 enrolled

A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg

Completed· Novartis logo

Novartis·Phase 3·NCT00171405·250 enrolled

Combined Renin Inhibition/Beta-blockade

Terminated·TThe Rogosin Institute·N/A·NCT00627861·1 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 5, 2007

TEKTURNA

NDA NDA021985

Nov 14, 2017

TEKTURNA

NDA NDA210709

Sources

References

[1]
ClinicalTrials.gov — 131 trial records for Aliskiren. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tekturna drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Aliskiren compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Aliskiren. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210709). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tekturna. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Tibotec Pharmaceuticals, Ireland company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Renin Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Tibotec Pharmaceuticals, Ireland

Patent Landscape[6]

Patent Cliff

Aug 19, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8617595Feb 19, 2026

8617595*PEDAug 19, 2026

Tekturna

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2029

Trials by Indication[1]

Hypertension22 trials

Essential Hypertension10 trials

Hypertensive9 trials

Heart Failure8 trials

Safety and Efficacy6 trials

High Blood Pressure6 trials

Efficacy and Safety4 trials

Type 2 Diabetes4 trials

Diabetes Mellitus3 trials

Metabolic Syndrome3 trials

Endothelial Function3 trials

Blood Pressure3 trials

Albuminuria2 trials

Left Ventricular Hypertrophy2 trials

Chronic Kidney Disease2 trials

Biomarkers2 trials

Kidney Transplant2 trials

Diabetic Macular Edema1 trial

Congestive Heart Failure1 trial

Dialysis Patients1 trial

Combination Therapy1 trial

Endothelial Dysfunction1 trial

Kidney1 trial

Systolic Heart Failure1 trial

Cardiac Transplant1 trial

Treatment1 trial

Membranous Nephropathy1 trial

Acute Coronary Syndrome1 trial

CLE1 trial

IgA Nephropathy1 trial

Atrial Fibrillation1 trial

ESS1 trial

C3 Glomerulopathy1 trial

Coronary Artery Disease1 trial

Kidney Disease1 trial

Diabetes1 trial

Hyperuricemia1 trial

Diabetic Nephropathy1 trial

Type 2 Diabetes Mellitus1 trial

Medication1 trial

Randomized Controlled Trial1 trial

ALD1 trial

Myocardial Infarction1 trial

Vitamin D Deficiency1 trial

Hemodynamic1 trial

End-Stage Renal Disease1 trial

Drug1 trial

Nephropathy1 trial

Plaque1 trial

ART1 trial

Insulin Sensitivity1 trial

Peritoneal Dialysis1 trial

Atherosclerosis1 trial

IgAN1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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