TheraRadar
Data updated: Jul 17, 2026

PREXXARTAN (valsartan) · CARMEL BIOSCIENCES

Approved 2017-12-19

PREXXARTAN is FDA-approved to treat 5 conditions (same as DIOVAN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-12-19
Routes
ORAL
Dosage Forms
SOLUTION

Companies

CARMEL BIOSCIENCES
Active Ingredient: VALSARTAN

PREXXARTAN Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Dec 2017 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What PREXXARTAN Treats

5 indications

PREXXARTAN is approved for 5 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as DIOVAN (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

67 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
NCT07139405 RESILIENCE-2a MYP-001 IND136121 Ph 2 not yet recruiting TriGlytza®-01 Versus Metformin in Overweight and Obese Adults With Type 2 Diabetes and Inadequate Glycaemic Control Despite Metformin Therapy
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

Showing 50 of 67 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

PREXXARTAN FDA Label Details

Indications & Usage

FDA Label (PDF)

PREXXARTAN is FDA-approved to treat 5 conditions — same approved indications as DIOVAN.

Track PREXXARTAN with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA209139 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.