You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 28, 2025

CLINICAL TRIALS PROFILE FOR VALSARTAN


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Valsartan

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04047940 ↗ A Study of LY900020 in Healthy Chinese Participants Completed Eli Lilly and Company Phase 1 2019-11-29 This study will evaluate three new formulations of LY900020; a fixed dose, combination drug developed for people with type 2 diabetes mellitus. The study will be conducted in healthy participants to investigate the effect of different tablet formulations on the amount of LY900020 in the bloodstream. Side effects and tolerability will be documented. The study will last about 10 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Valsartan

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed Bayer Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed GlaxoSmithKline Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗ Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose Completed Boehringer Ingelheim Phase 4 2001-10-01 The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00089518 ↗ Optimal Treatment for Kidney Disease in HIV Infected Adults Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 1969-12-31 The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to ART alone in slowing kidney disease progression in people with HIV.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Valsartan

Condition Name

Condition Name for Valsartan
Intervention Trials
Hypertension 162
Heart Failure 35
Healthy 19
Essential Hypertension 14
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Valsartan
Intervention Trials
Hypertension 174
Heart Failure 70
Essential Hypertension 29
Diabetes Mellitus 26
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Valsartan

Trials by Country

Trials by Country for Valsartan
Location Trials
United States 698
Italy 181
China 111
Spain 87
Korea, Republic of 86
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Valsartan
Location Trials
New Jersey 47
California 30
New York 26
Texas 26
Pennsylvania 25
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Valsartan

Clinical Trial Phase

Clinical Trial Phase for Valsartan
Clinical Trial Phase Trials
Phase 4 164
Phase 3 104
Phase 2/Phase 3 6
[disabled in preview] 36
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Valsartan
Clinical Trial Phase Trials
Completed 247
Recruiting 45
Not yet recruiting 30
[disabled in preview] 24
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Valsartan

Sponsor Name

Sponsor Name for Valsartan
Sponsor Trials
Novartis 91
Novartis Pharmaceuticals 56
Boehringer Ingelheim 7
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Valsartan
Sponsor Trials
Other 313
Industry 240
NIH 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Valsartan: Clinical Trials, Market Analysis, and Projections

Introduction to Valsartan

Valsartan is a widely used angiotensin II receptor antagonist, primarily prescribed for the treatment of hypertension, heart failure, and heart attack. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

LIFE Trial

One of the significant clinical trials involving valsartan is the LIFE trial, which focused on patients with advanced heart failure with reduced ejection fraction (HFrEF) and comorbidities. The trial compared the combination therapy of sacubitril/valsartan with valsartan alone.

  • Study Design: Patients were randomized to receive either sacubitril/valsartan or valsartan. The starting doses were 24/26 mg or 49/51 mg BID for sacubitril/valsartan and 40 or 80 mg BID for valsartan, with the option to uptitrate to 97/103 mg BID and 160 mg BID, respectively, if tolerated after 4 weeks[1].
  • Outcomes: The trial found that the combination therapy did not reduce NT-proBNP levels or improve clinical outcomes among these patients, suggesting that valsartan alone may be sufficient in certain cases[1].

Market Analysis

Current Market Size

As of 2023, the global market for valsartan was estimated to be worth approximately $589 million. This market is diverse, with multiple players and various formulations.

Key Players

The valsartan market is dominated by several major pharmaceutical companies, including Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, and others. These companies are continually expanding their product portfolios and market presence[2][3].

Market Segmentation

The valsartan market is segmented based on type and application.

  • Types: The market includes various tablet strengths such as 40 mg, 80 mg, 160 mg, and 320 mg tablets. The 40 mg tablets segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth[3][5].
  • Applications: The primary applications of valsartan are in the treatment of hypertension, heart failure, and heart attack. The hypertension segment is expected to expand at a significant CAGR throughout the forecast period[3][5].

Market Projections

Forecasted Market Size

The global valsartan market is forecasted to grow to $866.2 million by 2030, with a compound annual growth rate (CAGR) of 6.4% during the period from 2024 to 2030[2].

Regional Analysis

The market analysis covers global, regional, and country-level insights. The report provides detailed forecasts and segment analysis, helping to understand the driving factors for growth in different regions[5].

Growth Factors and Trends

The growth of the valsartan market is driven by increasing prevalence of cardiovascular diseases, an aging population, and advancements in healthcare infrastructure. However, the market also faces challenges such as patent expirations and the impact of COVID-19 on the pharmaceutical industry[5].

Legal and Regulatory Updates

Valsartan Cancer Lawsuits

There have been significant legal developments surrounding valsartan due to contamination issues. The Mansouri study published in the Journal of the American Heart Association found that patients exposed to contaminated valsartan had a higher risk of liver cancer and melanoma. This has led to ongoing lawsuits, with the first trial set for November 2024. Settlement negotiations are underway, particularly with companies like Teva and Torrent[4].

Industry Trends and Opportunities

Technological and ESG Analysis

The valsartan market report includes analyses of technological trends, environmental, social, and governance (ESG) factors, and Porter's Five Forces analysis. These insights help in understanding the competitive landscape and identifying opportunities for growth[5].

Consumer Behavior Analysis

The report also includes an analysis of consumer behavior, which is crucial for pharmaceutical companies to tailor their strategies and product offerings to meet patient needs effectively[5].

Key Takeaways

  • Clinical Trials: The LIFE trial indicated that valsartan alone may be sufficient for certain patients with advanced heart failure.
  • Market Size: The global valsartan market was valued at $589 million in 2023 and is projected to reach $866.2 million by 2030.
  • Key Players: Major pharmaceutical companies like Novartis, Teva, and Mylan dominate the market.
  • Applications: Valsartan is primarily used for hypertension, heart failure, and heart attack.
  • Legal Updates: Ongoing lawsuits related to contaminated valsartan are a significant concern.

FAQs

What is the current market size of the valsartan drug market?

The global market for valsartan was estimated to be worth approximately $589 million in 2023[2].

What is the projected market size of the valsartan drug market by 2030?

The global valsartan market is forecasted to grow to $866.2 million by 2030[2].

What are the primary applications of valsartan?

The primary applications of valsartan are in the treatment of hypertension, heart failure, and heart attack[3][5].

Which companies are the key players in the valsartan market?

Key players include Novartis, Sun Pharmaceutical, Teva, Mylan, Alembic Pharmaceuticals, and others[2][3].

What are the legal issues surrounding valsartan?

There are ongoing lawsuits related to contaminated valsartan, which has been linked to an increased risk of liver cancer and melanoma[4].

Sources

  1. American College of Cardiology: "LCZ696 in Advanced Heart Failure - American College of Cardiology" (2021)
  2. Valuates Reports: "Valsartan Drug - Market Size - Valuates Reports"
  3. Cognitive Market Research: "Valsartan Drug Market Report 2024 (Global Edition)"
  4. Lawsuit Information Center: "Valsartan Cancer Lawsuit Settlement Update | January 2025"
  5. Cognitive Market Research: "Valsartan Market Report 2024 (Global Edition)"

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.