VALSARTAN
Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension ,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which valsartan principally belongs.
Details
- Status
- Prescription
- First Approved
- 2014-06-26
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
Companies
VALSARTAN Approval History
What VALSARTAN Treats
16 FDA approvalsOriginally approved for its first indication in 2014 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (Jun 2014)Label Letter
- • Approved indication (Jan 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Jan 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Apr 2018)
- • Approved indication (May 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Oct 2021)
- • Approved indication (Oct 2021)
- • Approved indication (Nov 2021)Letter
- • Approved indication (Jul 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Jun 2025)
- • Approved indication (Apr 2026) New
VALSARTAN Boxed Warning
FETAL TOXICITY When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( ...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )
Clinical Trial Registry
66 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07539298 VALORIA | 2026-4550 | Ph 2, Ph 3 | not yet recruiting | Effects of VALsartan On atRIAl Mitral Regurgitation |
| NCT05194111 TREAT-HF | MCC-21-18830 HM20023601 | Ph 1, Ph 2 | recruiting | Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan |
| NCT06536309 | 2024P001894 1K23HL168163-01A1 | Ph 4 | not yet recruiting | Neprilysin Inhibition to Reduce Myocardial Fibrosis in Heart Failure With Preserved Ejection Fraction |
| NCT05528419 | SUPERIOR | Ph 4 | completed | Sacubitril Valsartan in Preventing the Recurrence of Atrial Fibrillation After Ablation in Elderly Hypertensive Patients With Atrial Fibrillation |
| NCT07331389 | HDM1002-111 | Ph 1 | recruiting | A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin |
| NCT05056727 STABILIZE-CKD results posted | D9488C00001 2021-001911-96 | Ph 3 | terminated | 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 |
| NCT06643819 | A119_01HTN2312 | Ph 3 | recruiting | Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-202A |
| NCT03738878 results posted | IRB#170762 | Ph 4 | terminated | Mechanism(s) Underlying Hypotensive Response to ARB/NEP Inhibition - Aim 1 |
| NCT03553810 REVERSE-LVH | 2018/2182 | Ph 2 | completed | Role of ARNi in Ventricular Remodeling in Hypertensive LVH |
| NCT05170061 ACRPP results posted | BYS-IT-76 | Ph 3 | completed | 24 Hour Ambulatory Cardiac Oxygen Consumption |
| NCT03928158 | AAAA-A18-118022290061-2 | Ph 2 | completed | LCZ696 in Advanced LV Hypertrophy and HFpEF |
| NCT03988634 PARAGLIDE-HF results posted | CLCZ696DUS01 | Ph 3 | completed | Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF) |
| NCT06771245 | SYH9056-002 | Ph 3 | not yet recruiting | A Phase III Clinical Trial Evaluating the Efficacy and Safety of Valsartan/Levamlodipine (SYH9056) Tablets In Hypertensive Patients |
| NCT02884206 PERSPECTIVE results posted | CLCZ696B2320 2016-001254-17 | Ph 3 | completed | Efficacy and Safety of LCZ696 Compared to Valsartan on Cognitive Function in Patients With Chronic Heart Failure and Preserved Ejection Fraction |
| NCT06501651 Hyper-Save | Ethical Review 2024(15-1) | Ph 4 | not yet recruiting | Sacubitril/Valsartan Treats Patients With Essential Hypertension and Type 2 Diabetic Nephropathy |
| NCT05359068 | SPH3127-301 | Ph 3 | completed | Study to Evaluate the Efficacy and Safety of SPH3127 In Patients With Mild-moderate Essential Hypertension |
| NCT03300427 TurkuPET results posted | CLCZ696BFI03 2017-002113-64 | Ph 4 | completed | The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients |
| NCT02924727 PARADISE-MI results posted | CLCZ696G2301 2016-002154-20 | Ph 3 | completed | Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI |
| NCT05681273 | CGZ110 | Ph 1 | completed | Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects. |
| NCT03279861 | HP-00076889 | Ph 4 | withdrawn | Sacubitril-valsartan Versus Usual Anti-hypertensives in LVAD |
| NCT03552575 RECOVER-LV results posted | GN16CA007 | Ph 3 | completed | The Effects of Sacubitril/Valsartan Compared to Valsartan on LV Remodelling in Asymptomatic LV Systolic Dysfunction After MI |
| NCT03315832 ARISTOTE | I16007 (ARISTOTE) | Ph 2, Ph 3 | withdrawn | Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study |
| NCT04606563 ARBs CORONA II | H20-01984 | Ph 3 | terminated | Host Response Mediators in Coronavirus (COVID-19) Infection - Is There a Protective Effect of Losartan and Other ARBs on Outcomes of Coronavirus Infection? |
| NCT04688294 | 3/2019 | Ph 4 | completed | The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure |
| NCT00657241 results posted | 111704 | Ph 3 | completed | Cardioprotective Benefits of Carvedilol-CR or Valsartan Added to Lisinopril |
| NCT02816736 HFN-LIFE results posted | Pro00071722 5U01HL084904 | Ph 4 | completed | EntrestoTM (LCZ696) In Advanced Heart Failure (LIFE Study) |
| NCT03066804 PARALLAX results posted | CLCZ696D2302 2016-003410-28 | Ph 3 | completed | A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients |
| NCT04912167 PERI-STEMI | WestChinaH-CVD-003 | Ph 3 | not yet recruiting | The Effects of Sacubitril-Valsartan vs Enalapril on Left Ventricular Remodeling in ST-elevation Myocardial Infarction |
| NCT03893526 NEPT2D | NEPT2D | Ph 4 | completed | Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes |
| NCT01912534 VANISH | VANISH 5P50HL112349 | Ph 2 | completed | Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCM |
| NCT01920711 PARAGON-HF results posted | CLCZ696D2301 2013-001747-31 | Ph 3 | completed | Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction |
| NCT04047940 | 16968 I9J-MC-DIPA | Ph 1 | completed | A Study of LY900020 in Healthy Chinese Participants |
| NCT02973035 | YMC016 | Ph 4 | completed | Amlodipine Versus Valsartan for Improvement of Diastolic Dysfunction Associated With Hypertension |
| NCT02480764 results posted | TAK-491_305 U1111-1159-5579 | Ph 3 | completed | Azilsartan Medoxomil (TAK-491) Compared to Valsartan in Chinese Participants With Hypertension |
| NCT03532854 | LG-EVCL001 | Ph 1 | completed | Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802 |
| NCT02058823 IH2 | 2011-32 P-2011-32-HI2 | Ph 4 | terminated | Intermittent Hypoxia 2: Cardiovascular and Metabolism |
| NCT03415906 ARNI-Sy | M17-05-LCZ-ARNI | Ph 2 | withdrawn | Influences of Angiotensin-neprilysin Inhibition on Sympathetic Activity in Heart Failure |
| NCT02572960 AldOst | 2014-LSB | Ph 4 | completed | Physiologic Interactions Between the Adrenal- and the Parathyroid Glands |
| NCT02687932 PRIME | 2015-0938 | Ph 4 | completed | Pharmacological Reduction of Functional, Ischemic Mitral REgurgitation |
| NCT02631031 | Ph.D (No.26) | Ph 1 | completed | Chronopharmacology of Valsartan in Normotensive Subjects |
| NCT02495324 FAST | BR-FVO-CT-401 | Ph 4 | completed | Fimasartan Achieving SBP Target (FAST) Study |
| NCT01541189 | CVAL489ACN14 | Ph 4 | completed | Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients. |
| NCT03012763 | GIT-Physiol_2016 | Ph 1 | completed | Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums |
| NCT00839683 | MB102-036 | Ph 1 | completed | Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects |
| NCT01365481 results posted | CVAL489K2305 2009-017594-37 | Ph 3 | completed | Safety and Tolerability of Valsartan in Children 6 to 17 Years of Age |
| NCT01672476 fimasartan | A657-BR-CT-L301 | Ph 3 | completed | A Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension |
| NCT02815657 | HR-SP-106 | Ph 1 | completed | The Drug-drug Interaction of SP2086 and Valsartan |
| NCT01281306 results posted | CLCZ696A2223 2010-022326-32 | Ph 2 | completed | An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension |
| NCT01353508 results posted | CLCZ696B2223 | Ph 2 | completed | Sodium Excretion of LCZ696 in Patients With Hypertension; Heart Failure and Healthy Volunteers |
| NCT01681576 results posted | CLCZ696A2222 | Ph 2 | completed | Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension |
Showing 50 of 66 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VALSARTAN FDA Label Details
Indications & Usage
FDA Label (PDF)Valsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Hypertension ,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV); valsartan tablets significantly reduced hospitalization for heart failure Post-myocardial infarction ; for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction 1.1 Hypertension Valsartan tablets are indica...
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete box...
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Full clinical data, patents, trials, and competitive landscape for valsartan.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.