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Last update 10 Sep 2025

Valsartan

Last update 10 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryValsartan, a diminutive molecular compound, falls within the pharmacological group of angiotensin receptor blockers (ARBs), which exhibit the ability to selectively obstruct the angiotensin receptor type 1 (AR1R), hence deterring the effects of angiotensin II on the blood vessels, and consequently regulating the blood pressure. It is noteworthy that Valsartan is primarily intended to treat hypertension, heart failure, and myocardial infarction, with its debut approval by the FDA dating back to December 1996, all thanks to the efforts of Novartis in developing it. Valsartan has become widely recognized and hailed as a vital drug in the management of cardiovascular diseases, which serves as a testament to its efficacy and utility.

Drug Type

Small molecule drug

Synonyms

(S)-N-Valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]-methyl}-valine, Diovane, Kalpress

+ [25]

Target

AT1R

Action

antagonists

Mechanism

AT1R antagonists(Angiotensin II Receptor Type 1 antagonists)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Myocardial InfarctionHeart FailureHypertension

Inactive Indication

Acute Coronary SyndromeAcute Ischemic StrokeChronic heart failure+ [13]

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Pharmaceuticals Australia Pty Ltd.

Novartis Pharmaceuticals Corp.

Novartis Pharma KK

Inactive Organization

Novartis AG

Novartis Pharmaceuticals Canada, Inc.

Carmel Biosciences, Inc.

License Organization

Medicure, Inc.

Carmel Biosciences, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (23 Dec 1996),

Heart FailureHypertension

Regulation-

Structure/Sequence

Molecular FormulaC24H29N5O3

InChIKeyACWBQPMHZXGDFX-QFIPXVFZSA-N

CAS Registry137862-53-4

385

Clinical Trials associated with Valsartan

NCT07139405

/ Not yet recruitingPhase 2

A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, PHASE II TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND SUPERIORITY OF TRIGLYTZA® OVER METFORMIN IN PATIENTS WITH INADEQUATE GLYCEMIC CONTROL OVER 24 WEEKS OF TREATMENT

Type 2 diabetes (T2DM) is still very difficult to treat because current medicines mostly help with symptoms but don't stop the damage happening inside the pancreas. Many people who start on common treatments like Metformin, and even newer drugs like Ozempic, eventually stop responding to them. This is because these drugs don't address the real problem: the gradual loss of the pancreas' ability to make insulin and the body's increasing resistance to it.
Myopharm is developing a new treatment called TriGlytza®, which combines existing medicines (Celecoxib and Valsartan) with Metformin. This new approach is designed to target the inflammation and biological pathways that cause ongoing damage in Type 2 diabetes, aiming to protect the pancreas and reduce insulin resistance. Early animal studies and past clinical trials with the individual drugs show promising results.
The number of people with Type 2 diabetes is expected to double by 2045, and the disease brings huge health and financial costs. It also raises the risk of heart disease, stroke, kidney damage, nerve problems, vision loss, certain cancers, and even conditions like Alzheimer's. Because of this, a treatment that addresses the root causes rather than just symptoms could make a major difference.
TriGlytza® aims to provide a safe, affordable, and more effective long-term treatment than current options, helping people manage their diabetes better and avoid related health problems.

Start Date01 Feb 2026

Sponsor / Collaborator

Myopharm Ltd.

ChiCTR2500108026

Not ApplicableIIT

Efficacy and safety of Ambrisentan on idiopathic membranous nephropathy----a prospective, multi-center, randomized and controlled study

Start Date01 Sep 2025

Sponsor / Collaborator

The Second Military Medical University

[+1]

CTR20251636

/ Active, not recruitingNot Applicable

缬沙坦胶囊人体生物等效性试验

[Translation] Bioequivalence study of valsartan capsules in human body

主要目的：本研究以江苏万高药业股份有限公司生产并持有的缬沙坦胶囊（规格：80 mg）为受试制剂，按生物等效性研究的有关规定，以原研厂家北京诺华制药有限公司生产并持有的缬沙坦胶囊（规格：80 mg，商品名：代文®）为参比制剂，评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。次要目的：观察受试制剂缬沙坦胶囊和参比制剂缬沙坦胶囊（商品名：代文®）在健康受试者中的安全性。

[Translation]

Main purpose: This study uses valsartan capsules (specification: 80 mg) produced and owned by Jiangsu Wangao Pharmaceutical Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, valsartan capsules (specification: 80 mg, trade name: Diovan®) produced and owned by the original manufacturer Beijing Novatis Pharmaceutical Co., Ltd. are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions. Secondary purpose: Observe the safety of the test preparation valsartan capsules and the reference preparation valsartan capsules (trade name: Diovan®) in healthy subjects.

Start Date07 May 2025

Sponsor / Collaborator

Jiangsu Vanguard Pharmaceutical Co.,Ltd.

100 Clinical Results associated with Valsartan

100 Translational Medicine associated with Valsartan

100 Patents (Medical) associated with Valsartan

7,795

Literatures (Medical) associated with Valsartan

01 Dec 2025·Journal of Gastrointestinal Cancer

Retraction Note: Angiotensin II Receptor Antagonist, Valsartan, Has Beneficial Effect in Lung Metastasis of Colorectal Cancer Treated with Fluorouracil

Article

Author: Naghibzadeh, Niloufar ; Avan, Amir ; Khazaei, Majid ; Mostafapour, Asma ; Hassanian, Seyed Mahdi ; Hashemzehi, Milad ; Asgharzadeh, Fereshteh

01 Dec 2025·AMERICAN JOURNAL OF CARDIOLOGY

Differences in Characteristics and Clinical Outcomes According to Age in Patients Following High-Risk Myocardial Infarction: Insights from PARADISE-MI

Article

Author: Solomon, Scott David ; Rouleau, Jean Lucien ; Køber, Lars ; Merkely, Bela ; Amir, Offer ; Landmesser, Ulf ; DePasquale, Carmine ; Maggioni, Aldo Pietro ; Senni, Michele ; McMurray, John Jv ; Claggett, Brian Lee ; Pfeffer, Marc Alan ; Opolski, Grzegorz ; Claeys, Marc J ; Jering, Karola Simone ; Lewis, Eldrin Foster ; van der Meer, Peter ; Granger, Christopher Bull ; Cikes, Maja

The prevalence of coronary heart disease is increasing in an aging population. A better understanding of how risk profiles and outcomes differ by age may allow for targeted treatment and prevention strategies. PARADISE-MI randomized 5661 adults without prior heart failure (HF) to sacubitril/valsartan versus ramipril within 0.5 to 7 days of a MI complicated by pulmonary congestion and/or LVEF ≤40%. Associations between age and clinical outcomes were analyzed using Cox models, adjusted for potential confounders. Mean age was 63.7 ± 11.5 years. Patients aged ≥75 years (n = 1051, 18.6%) were more often women, had more atrial fibrillation and lower eGFR. They more commonly presented with non-ST-segment elevation MI and were less likely to receive primary reperfusion and guideline-based medical therapies. Age was associated with all-cause death (HR 1.54 per 10-year increase; 95% CI, 1.41 to 1.68) and was more strongly associated with non-CV death (HR 2.09; 95% CI, 1.70 to 2.56) than with CV death (HR 1.43; 95% CI, 1.29 to 1.57). Age was associated with incident HF (HR 1.37; 95% CI, 1.25 to 1.49) and stroke (HR 1.31; 95% CI, 1.11 to 1.54). These risk relationships were similar after multivariable adjustment. The treatment effect of sacubitril/valsartan versus ramipril was not significantly modified by age (p-interaction = 0.19) and tolerability did not differ by treatment arm. In conclusion, the heightened risk of death, HF and stroke after MI with advancing age was not explained by differences in clinical characteristics. Older patients may require closer surveillance and more guidelines-based therapies after MI to mitigate the elevated risk of death and HF.

01 Nov 2025·JOURNAL OF PHOTOCHEMISTRY AND PHOTOBIOLOGY A-CHEMISTRY

Effect of microplastics on the photodegradation of high-consumption drugs under simulated sunlight: The critical role of aging and reactive oxygen species

Author: Kyzas, George Z. ; Kalaronis, Dimitrios ; Bikiaris, Dimitrios N. ; Evgenidou, Eleni ; Lambropoulou, Dimitra A. ; Teknetzi, Aikaterini ; Vourlias, George

The main aim of this study was to examine the effect of polypropylene (PP), poly(ethylene terephthalate) (PET), and poly(lactic acid) (PLA) microplastics (MPs) on the photolytic degradation of a mixture of seven commonly used pharmaceuticals under simulated solar irradiation (SSL).The target mixture included four common antibiotics (metronidazole, trimethoprim, indomethacin, isoniazid), two non-steroidal anti-inflammatory drugs (diclofenac, ketoprofen), and one antihypertensive drug (valsartan).The selected MPs were aged using three different procedures: (i) SSL light, (ii) UV/H₂O₂, and (iii) Fenton reagent.The effect of MPs mass concentration was examined using only the pristine MPs, while the aging effect was evaluated for the three different aged MPs for each polymer type.The results demonstrated that the presence of MPs generally accelerates the photolytic degradation of the drugs, and increasing their concentration further enhances the reaction rate.Aging of the MPs also appeared to enhance the photodegradation of the selected pharmaceuticals.Among the various aging processes applied, UV/H2O2 had the greatest impact on surface alteration of the MPs and consequently, UV/H₂O₂-aged PET MPs exhibited the highest influence on the photolytic degradation of the drugs.To gain a deeper understanding of the mechanism behind the photolytic degradation of the examined pharmaceuticals, a systematic characterization of pristine and aged MPs was conducted using Fourier transformed IR spectroscopy (FTIR), XPS, and SEM-energy dispersive X-ray spectroscopy (SEM-EDX) techniques, which detected the formation of oxygen containing groups on the MPs' surfaces.Finally, scavenger experiments were also conducted to explore the formation and role of reactive oxygen species (singlet oxygen, superoxide anions, and hydroxyl radicals) in the degradation of the target compounds

News (Medical) associated with Valsartan

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

29 Aug 2025

·www.einpresswire.com

April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab and hyaluronidase human) Ruxience (rituximab-pvvr) Truxima (rituximab-abbs) Colitis FDA determined that no action is necessary at the time based on available information. Balversa (erdafitinib) Calciphylaxis The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis. Balversa labeling Bavencio (avelumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Yervoy (ipilimumab) Imfinzi (durvalumab) * Necrotizing fasciitis FDA determined that no action is necessary at this time based on available information. *An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted. Beta-blockers Betapace (sotalol hydrochloride) Brevibloc (esmolol hydrochloride) Bystolic (nebivolol) Byvalson (nebivolol and valsartan) Coreg (carvedilol) Coreg CR (carvedilol) Corgard (nadolol) Corzide (nadolol and bendroflumethiazide) Dutoprol (metoprolol succinate and hydrochlorothiazide) Kapspargo Sprinkle (metoprolol succinate) Lopressor HCT (metoprolol tartrate and hydrochlorothiazide) Sectral (acebutolol hydrochloride) Sotylize (sotalol hydrochloride) Tenoretic (atenolol and chlorthalidone) Toprol XL (metoprolol succinate) Trandate (labetalol hydrochloride) Ziac (bisoprolol fumarate and hydrochlorothiazide) Generic products containing beta-blockers Hemangeol (Propranolol Hydrochloride)* Inderal LA (Propranolol Hydrochloride)* Innopran XL (Propranolol hydrochloride)* Lopressor (metoprolol tartrate)* Tenormin (Atenolol)* Hypoglycemia in pediatric patients The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia. Example: Coreg labeling An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting. *An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted. Bosulif (bosutinib monohydrate) Gleevec (imatinib mesylate) Iclusig (ponatinib) Sprycel (dasatinib) Tasigna (nilotinib) Osteonecrosis The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis. Tasigna labeling FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time. FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information. Cablivi (caplacizumab-yhdp) Hemorrhage The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding. Cablivi labeling Cyramza (ramucirumab) Cardiac failure The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure. Cyramza labeling Doxil (doxorubicin hydrochloride) Acute interstitial pneumonitis FDA determined that no action is necessary at the time based on available information. Gleevec (imatinib mesylate) Tasigna (nilotinib) Myasthenia gravis FDA determined that no action is necessary at the time based on available information. Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (ribociclib; letrozole) Verzenio (abemaciclib) Radiation recall phenomenon FDA determined that no action is necessary at the time based on available information. Lokelma (sodium zirconium cyclosilicate) Gastrointestinal disorders FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pancreatitis FDA determined that no action is necessary at the time based on available information. Padcev (enfortumab vedotin-ejfv) Pneumonitis The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis. Padcev labeling Poteligeo (mogamulizumab-kpkc) Cytomegalovirus viraemia The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection. Poteligeo labeling Procysbi (cysteamine bitartrate) Generic products containing cysteamine bitartrate Fibrosing colonopathy The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy. Example: Procysbi labeling Sarclisa (isatuximab-irfc) Herpes zoster The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster. Sarclisa labeling Sprycel (dasatinib) Drug-induced liver injury The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity. Sprycel labeling Taxotere (docetaxel) Rhabdomyolysis FDA determined that no action is necessary at the time based on available information. Veklury (remdesivir) Bradycardia FDA determined that no action is necessary at the time based on available information. Zepzelca (lurbinectedin) Extravasation The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation. Zepzelca labeling Zepzelca (lurbinectedin) Tumor lysis syndrome The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome. Zepzelca labeling Zepzelca (lurbinectedin) Rhabdomyolysis The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis. Zepzelca labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

19 Aug 2025

·www.prnewswire.com

MSN Marks Major Milestone with U.S. Launch of Sacubitril and Valsartan Tablets Following Hard-Fought Legal Victory

PISCATAWAY, N.J., Aug. 19, 2025 /PRNewswire/ -- MSN Pharmaceuticals, the U.S. subsidiary of global pharmaceutical leader MSN Group, is pleased to announce the launch of its generic Sacubitril+Valsartan Tablets in the United States, which is indicated to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure and reduced ejection fraction. This marks a significant achievement in MSN's journey to expand access to affordable, high-quality cardiovascular medications for patients across the country. Sacubitril and Valsartan Tablets is an important combination therapy widely used in the management of chronic heart failure with reduced ejection fraction. It helps to reduce the risk of cardiovascular death and hospitalizations, offering hope and an improved quality of life to patients throughout the United States. MSN's path to launch was shaped by a rigorous legal and regulatory process. The company was at the forefront of a complex patent litigation that spanned multiple years. Despite facing multiple legal obstacles, including attempts to delay the approvals and launch of the product, MSN remained committed to its mission and engaged in a principled defence of its right to be first to introduce its cost effective generic product. Throughout this process, MSN Pharmaceuticals worked in close coordination with regulatory authorities and adhered to the highest standards of legal compliance and product quality. After multiple court hearings, temporary injunctions, and legal appeals, MSN ultimately secured the necessary approvals to bring its Sacubitril and Valsartan tablets to the U.S. market. "This launch stands as a symbol of our perseverance, integrity, and unwavering belief that lifesaving medicines must be accessible to all. Aligned with the U.S. government's vision and policy of promoting reduced drug prices through the promotion of robust generic pharmaceutical competition, this milestone reflects our enduring commitment to strengthening global healthcare access through our facilities in the USA as well" MSN Pharmaceuticals said in a statement. MSN Group is among the fastest-growing, fully integrated pharma companies with 25 state-of-the-art facilities in India and the USA. Its unified R&D drives both APIs and finished dosage research. With 1000+ patents, 200+ ANDAs, and the world's No.1 position in US DMF filings, MSN offers 500+ APIs and 400+ finished dosages across 35+ therapeutic areas, serving 50M+ patients in 100+ countries with speed, reliability, and trust. SOURCE MSN Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPatent Infringement

100 Deals associated with Valsartan

External Link

KEGG	Wiki	ATC	Drug Bank
D00400	Valsartan	C09CA03	DB00177

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Ventricular Dysfunction, Left	United States	Carmel Biosciences, Inc.	19 Dec 2017
Myocardial Infarction	Australia	Novartis Pharmaceuticals Australia Pty Ltd.	13 Nov 2001
Heart Failure	United States	Novartis Pharmaceuticals Corp.	23 Dec 1996
Hypertension	United States	Novartis Pharmaceuticals Corp.	23 Dec 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	Phase 3	United States	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Belgium	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	France	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Germany	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Hungary	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	India	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Italy	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Poland	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Chronic Kidney Diseases	Phase 3	Turkey	Novartis Pharmaceuticals Canada, Inc.	01 Jun 2007
Hypertrophy, Left Ventricular	Phase 3	Germany	Novartis AG	01 Mar 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05170061 (ACRPP, CTgov)	Phase 3	Hypertension	26	Nebivolol (Nebivolol)	hjurnodzsd(sesfkalisu) = xxqokgrepj kzfywzyalq (bbhtddtqpg, 400) View more	-	08 Jun 2025
				Valsartan (Valsartan)	hjurnodzsd(sesfkalisu) = zecvhztygm kzfywzyalq (bbhtddtqpg, 530) View more
NCT01912534 (VANISH, Pubmed \| JAMA Cardiol)	Phase 2	Cardiomyopathy, Hypertrophic	137	Valsartan	fpuijyzykd(zdqcuphiim) = qjaavsxinx oznyfkluey (vtmpgpmacc ) View more	Positive	01 Jun 2025
NCT03552575 (RECOVER-LV, CTgov)	Phase 3	Myocardial Infarction \| Heart Failure \| Left ventricular systolic dysfunction ... View more	93	sacubitril/valsartan (Sacubitril/Valsartan)	szdbeobkgp(ohahfvledj) = nmphqaddgd aoibkpuxoa (miwanefbzy, 6.6) View more	-	03 May 2023
				Valsartan (Valsartan)	szdbeobkgp(ohahfvledj) = vhpkzcctzr aoibkpuxoa (miwanefbzy, 7.3) View more
NCT02924727 (PARADISE-MI, Pubmed \| Circulation) Manual	Phase 3	Acute myocardial infarction	5,661	Sacubitril+Valsartan	olvkdcgwiq(sybtygicde): HR = 0.86 (95% CI, 0.74 - 0.99), P-Value = 0.04	Positive	02 Nov 2022
				Ramipril
NCT02816736 (HFN-LIFE \| LIFE, CTgov)	Phase 4	Heart Failure	365	valsartan placebo+LCZ696 (LCZ696 (Entresto) + Placebo)	bowlyiapnj(uczhvezxku) = josetgsuwx zabgqgychj (lrpylhldyi, 0.65) View more	-	03 Dec 2021
				LCZ696 placebo+valsartan (Valsartan + Placebo)	bowlyiapnj(uczhvezxku) = xgnwufjvxx zabgqgychj (lrpylhldyi, 0.50) View more
NCT01912534 (Pubmed \| Nat Med)	Phase 2	Cardiomyopathy, Hypertrophic	178	Valsartan	eaqoeciqwx(suarrhhjse): P-Value = 0.001	Positive	01 Oct 2021
				Placebo
NCT01617681 (Pubmed \| Curr Med Res Opin)	Phase 3	Hypertension \| Chronic Kidney Diseases	127	Valsartan 0.25 mg/kg/day	jfacxfvmta(swhptsanuc) = qnqftxaqtk jsfqxtobym (sxrripglhv )	-	20 Sep 2021
				Valsartan 4 mg/kg/day	jfacxfvmta(swhptsanuc) = uteuomhxxp jsfqxtobym (sxrripglhv )
NCT00457626 (CTgov)	Phase 3	Hypertension	66	Valsartan	wlezijkuon(pwpktxzepo) = rnxljtvvqu jvzprcpyyb (udtavumgue, 9.04) View more	-	20 May 2021
NCT01365481 (Pubmed \| Pediatr Nephrol) Manual	Phase 3	Hypertension	150	valsartan (CKD)	aeidluvmns(nidxttdral) = tueqeorcpx njflqcatvh (rpbeaioavw ) View more	Positive	01 Mar 2019
				valsartan (non-CKD)	aeidluvmns(nidxttdral) = yfcboherie njflqcatvh (rpbeaioavw ) View more

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