CLINICAL TRIALS PROFILE FOR VALSARTAN

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.

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.

Clinical Trial Conditions for Valsartan

Condition Name

Condition Name for Valsartan
Intervention	Trials
Hypertension	162
Heart Failure	35
Healthy	19
Essential Hypertension	14

Condition MeSH

Condition MeSH for Valsartan
Intervention	Trials
Hypertension	174
Heart Failure	70
Essential Hypertension	29
Diabetes Mellitus	26

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

Trials by US State

Trials by US State for Valsartan
Location	Trials
New Jersey	47
California	30
New York	26
Texas	26
Pennsylvania	25

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

Clinical Trial Status

Clinical Trial Status for Valsartan
Clinical Trial Phase	Trials
Completed	247
Recruiting	45
Not yet recruiting	30

Clinical Trial Sponsors for Valsartan

Sponsor Name

Sponsor Name for Valsartan
Sponsor	Trials
Novartis	91
Novartis Pharmaceuticals	56
Boehringer Ingelheim	7

Sponsor Type

Sponsor Type for Valsartan
Sponsor	Trials
Other	313
Industry	240
NIH	7

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)"