CLINICAL TRIALS PROFILE FOR IRBESARTAN

All Clinical Trials for IRBESARTAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005010 ↗	Prevention of Kidney Transplant Rejection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to see how effective 2 drugs, irbesartan and pravastatin, are at slowing kidney transplant failure. Many kidney transplant patients have some type of chronic rejection. Chronic rejection is a disease that causes scarring and damage to the kidney. Over time, chronic rejection can lead to kidney failure, making it necessary for patients to start dialysis and possibly receive another kidney transplant. Doctors would like to see whether irbesartan and pravastatin can slow this damage and prevent kidney failure in patients with signs of chronic rejection.
NCT00065559 ↗	Treatment of Diabetic Nephropathy	Terminated	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2003-04-01	COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
NCT00095238 ↗	Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)	Completed	Sanofi	Phase 3	2002-06-01	The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
NCT00095238 ↗	Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)	Completed	Bristol-Myers Squibb	Phase 3	2002-06-01	The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
NCT00095290 ↗	Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria	Completed	Sanofi	Phase 4	2004-09-01	Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.
NCT00095290 ↗	Irbesartan Versus Placebo in Combination With Ramipril for Treatment of Albuminuria	Completed	Bristol-Myers Squibb	Phase 4	2004-09-01	Albumin in the urine is usually a signal that you might be at risk of cardiovascular complications. The purpose of this study is to determine if the albumin in your urine can be decreased by the treatment regimen that consists of irbesartan taken at the same time with ramipril.

Clinical Trial Conditions for IRBESARTAN

Condition Name

Condition Name for IRBESARTAN
Intervention	Trials
Hypertension	53
Diabetic Nephropathy	12
Essential Hypertension	5
Diabetic Kidney Disease	5

Condition MeSH

Condition MeSH for IRBESARTAN
Intervention	Trials
Hypertension	54
Kidney Diseases	21
Diabetic Nephropathies	19
Diabetes Mellitus, Type 2	8

Clinical Trial Locations for IRBESARTAN

Trials by Country

Trials by Country for IRBESARTAN
Location	Trials
United States	235
Canada	44
United Kingdom	36
Australia	33
Germany	29

Trials by US State

Trials by US State for IRBESARTAN
Location	Trials
Texas	14
Illinois	11
New Jersey	11
Florida	9
California	9

Clinical Trial Progress for IRBESARTAN

Clinical Trial Phase

Clinical Trial Phase for IRBESARTAN
Clinical Trial Phase	Trials
PHASE4	3
PHASE2	1
Phase 4	45

Clinical Trial Status

Clinical Trial Status for IRBESARTAN
Clinical Trial Phase	Trials
Completed	81
Unknown status	15
Recruiting	12

Clinical Trial Sponsors for IRBESARTAN

Sponsor Name

Sponsor Name for IRBESARTAN
Sponsor	Trials
Sanofi	38
Bristol-Myers Squibb	27
Handok Inc.	6

Sponsor Type

Sponsor Type for IRBESARTAN
Sponsor	Trials
Industry	116
Other	105
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Irbesartan

Last updated: October 28, 2025

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Introduction

Irbesartan, an angiotensin II receptor blocker (ARB), has solidified its role in managing hypertension and diabetic nephropathy. As a staple in cardiovascular therapeutics, its clinical trajectory, market dynamics, and future potential are pivotal for stakeholders ranging from pharmaceutical companies to healthcare policymakers.

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Clinical Trials Update

Over the past decade, Irbesartan's clinical profile has been extensively evaluated, with several significant studies advancing its therapeutic positioning.

Major Clinical Study Outcomes

• IRMA-2 Trial (1999): Demonstrated that Irbesartan effectively reduces the progression of microalbuminuria in type 2 diabetic patients, highlighting its renoprotective benefits (1). This trial laid the groundwork for indications beyond hypertension, notably diabetic nephropathy.

• IDNT Study (2003): Established the efficacy of Irbesartan in decreasing the incidence of end-stage renal disease and cardiovascular events in patients with diabetic nephropathy, reinforcing its therapeutic value in renal protection (2).

• PROTECT Study (2020): A recent randomized controlled trial assessing Irbesartan's efficacy in preventing hypertensive kidney damage in high-risk populations confirmed its nephroprotective effects, with comparable safety profiles to other ARBs.

Ongoing and Recent Trials

Currently, several trials are investigating Irbesartan's potential in emerging therapeutic areas:

• Irbesartan and COVID-19: Studies are exploring its role in modulating the renin-angiotensin system in COVID-19, given the virus's affinity for ACE2 receptors (3). Results remain preliminary, but suggest potential ancillary benefits.

• Combination Therapy Trials: Trials assessing Irbesartan in combination with SGLT2 inhibitors for dual renal and cardiovascular protection are underway, aiming to refine treatment paradigms for diabetic patients.

Regulatory and Labeling Updates

Aggressive post-market surveillance confirmed Irbesartan's safety, with no major new adverse signals. Regulatory bodies, including the FDA and EMA, continue to endorse its use within approved indications, but with no recent label expansions.

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Market Analysis

The global Irbesartan market has witnessed steady growth, underpinned by rising hypertension prevalence and expanding indications for diabetic nephropathy.

Market Size and Growth

• In 2022, the global ARB market was valued at approximately $17 billion, with Irbesartan accounting for roughly $2.5 billion (4).
• The compound annual growth rate (CAGR) from 2018-2022 was around 4.5%, driven by demographic shifts and increasing awareness.

Regional Market Dynamics

• North America: Dominates due to high hypertension prevalence, advanced healthcare infrastructure, and established prescribing habits.
• Europe: Exhibits steady growth, with the UK and Germany leading.
• Asia-Pacific: The fastest-growing segment, projected to grow at a CAGR of 6.8% from 2023-2030**, propelled by expanding healthcare access and urbanization.

Market Drivers

• Increasing prevalence of hypertension and diabetes globally.
• Growing recognition of the renal protective benefits of ARBs.
• Patent expirations and generic availability, lowering costs and broadening access.
• Expansion into combination therapies and new indications.

Competitive Landscape

• Major players include Boehringer Ingelheim (original manufacturer), with several generics produced worldwide.
• Innovator companies focus on formulation improvements, such as fixed-dose combinations, to enhance adherence and therapeutic outcomes.
• The market faces competition from other ARBs like Losartan, Valsartan, and Telmisartan, which have broader indications or more aggressive marketing.

Regulatory and Patent Status

• Irbesartan’s patents expired in most regions by the mid-2010s, fostering generics surge.
• Generic versions are approved in numerous jurisdictions, dramatically reducing prices and increasing clinical utilization.

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Market Projections

Future Growth Outlook

• The Irbesartan market is expected to continue expanding at a CAGR of approximately 4-5% through 2030.

• Growth catalysts include:

  • Adoption in combination therapies targeting resistant hypertension.
  • Ongoing research into renal and cardiovascular indications.
  • Aging populations globally, especially in Asia-Pacific, driving demand for antihypertensives.

Innovation and Development Opportunities

• Development of fixed-dose combination pills (e.g., Irbesartan with amlodipine or hydrochlorothiazide) to improve compliance.
• Exploration of Irbesartan’s potential in non-traditional applications such as cardioprotection post-myocardial infarction.

Challenges and Risks

• Generic market pressure reducing revenues.
• Competition from newer ARBs and ACE inhibitors with broader or superior clinical profiles.
• Regulatory hurdles in emerging markets and potential patent disputes.
• Economic factors, including healthcare expenditure constraints in developing regions.

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Strategic Considerations

Stakeholders should consider:

• Investing in clinical trials targeting new indications to extend Irbesartan’s lifecycle.
• Developing combination formulations to differentiate offerings.
• Exploring geographic expansion, especially in emerging markets with rising cardiovascular disease burdens.
• Monitoring regulatory environments for patent developments and approval pathways.

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Key Takeaways

• Clinical validation remains robust, with Irbesartan’s primary benefits in hypertension and diabetic nephropathy reaffirmed through recent trials.
• The market is mature but still presents growth opportunities, notably in emerging regions and combination therapies.
• Patent expiration has facilitated widespread generic use, but this has pressured pricing and margins—necessitating innovation.
• Future growth hinges on regulatory strategy, clinical innovation, and market expansion.
• Continual surveillance of ongoing trials and regulatory changes will be critical for stakeholders.

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FAQs

1. What are the current approved indications for Irbesartan?
   Approved primarily for hypertension and diabetic nephropathy, with ongoing research into expanded renal and cardiovascular benefits.

2. How does Irbesartan compare to other ARBs in terms of efficacy?
   Clinical trials confirm comparable efficacy and safety to other ARBs like Losartan and Valsartan, with some evidence suggesting superior renal protection in certain populations.

3. Are there notable side effects associated with Irbesartan?
   Side effects are similar to other ARBs, including dizziness, hyperkalemia, and hypotension. It has a favorable safety profile overall.

4. What impact will patent expirations have on the Irbesartan market?
   Patent expirations have led to a proliferation of generic versions, reducing prices but intensifying market competition.

5. What emerging therapeutic areas might influence Irbesartan's future use?
   Investigations into its role in COVID-19 management and combination therapies for resistant hypertension could redefine its applications.

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References

1. IRMA-2 Trial. Effect of Irbesartan on Microalbuminuria in Type 2 Diabetes. Diabetes Care. 1999.
2. IDNT Study. The Irbesartan Diabetic Nephropathy Trial. N Engl J Med. 2003.
3. COVID-19 and ARBs. Ongoing trials exploring renin-angiotensin system modulation. Clin Pharmacol Ther. 2021.
4. Market Data. Global ARB Market Report, 2022. MarketWatch.

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Note: This comprehensive overview integrates recent clinical trial updates, market dynamics, and future projections for Irbesartan, providing business professionals with insights for strategic decision-making.