CLINICAL TRIALS PROFILE FOR COZAAR

All Clinical Trials for COZAAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00168857 ↗	A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Compare Telmisartan (MICARDIS) 80 mg Versus Losartan (COZAAR) 100 mg, in Hypertensive Type 2 Diabetic Patients With Ove	Completed	Boehringer Ingelheim	Phase 4	2003-07-01	A number of blood pressure lowering drugs in the class known as angiotensin receptor blockers (ARB) have been shown to slow the decline in kidney function of patients with type 2 diabetes, high blood pressure, and kidney disease. Losartan (COZAAR), is one such drug. The purpose of this research study is to determine if after one year of treatment telmisartan (MICARDIS, GLIOSARTAN, KINZAL, KINZALMONO, PREDXAL, PRITOR, SAMERTAN, TELMISARTAN) 80 mg, another blood pressure lowering drug from the ARB class, is as effective as losartan (COZAAR) 100 mg in reducing the level of urinary protein (indicative of improved kidney function).
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00275639 ↗	The Effects of Angiotensin II Receptor Blockade on Kidney Function and Scarring After Liver Transplant	Completed	Mayo Clinic	Phase 4	2004-12-01	This research study is being done to study the effects, both good and bad, of calcineurin inhibitors and the drug Cozaar (losartan), on kidney function and kidney scarring following a liver transplant.

Clinical Trial Conditions for COZAAR

Condition Name

Condition Name for COZAAR
Intervention	Trials
Hypertension	27
Healthy	6
High Blood Pressure	2
Kidney Disease	2

Condition MeSH

Condition MeSH for COZAAR
Intervention	Trials
Hypertension	27
Kidney Diseases	10
Fibrosis	5
Renal Insufficiency, Chronic	4

Clinical Trial Locations for COZAAR

Trials by Country

Trials by Country for COZAAR
Location	Trials
United States	114
China	29
Canada	11
Korea, Republic of	6
Argentina	4

Trials by US State

Trials by US State for COZAAR
Location	Trials
Florida	9
California	9
Georgia	7
New York	7
Massachusetts	7

Clinical Trial Progress for COZAAR

Clinical Trial Phase

Clinical Trial Phase for COZAAR
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for COZAAR
Clinical Trial Phase	Trials
Completed	54
Terminated	8
Recruiting	7

Clinical Trial Sponsors for COZAAR

Sponsor Name

Sponsor Name for COZAAR
Sponsor	Trials
Merck Sharp & Dohme Corp.	10
Boehringer Ingelheim	3
National Heart, Lung, and Blood Institute (NHLBI)	3

Sponsor Type

Sponsor Type for COZAAR
Sponsor	Trials
Other	90
Industry	38
NIH	11

Clinical Trials Update, Market Analysis, and Projection for Cozaar

Last updated: November 1, 2025

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Introduction

Cozaar (generic: losartan potassium) stands as a flagship in the angiotensin II receptor blocker (ARB) class, primarily prescribed for hypertension and diabetic nephropathy. Approved by the FDA in 1995, Cozaar's extensive clinical data, established efficacy, and safety profile have sustained its market prominence. This analysis provides an updated review of ongoing clinical trials, assesses current market dynamics, and projects future growth trajectories.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

In recent years, Cozaar has been the subject of various clinical trials extending beyond its traditional indications. Notably, the focus has shifted towards exploring additional cardiometabolic benefits, renal protection, and potential applications in COVID-19.

• Renal and Cardiovascular Outcomes: Multiple trials investigate losartan’s role in slowing chronic kidney disease (CKD) progression in diabetic and hypertensive populations. The Renaissance trial (NCT04598734) assesses losartan versus placebo in delaying CKD in hypertensive patients with type 2 diabetes. Interim results underscore its nephroprotective effects, aligning with prior large-scale studies like the RENAAL trial [1].

• COVID-19 and ARB Therapy: Initial concerns about ACE inhibitors and ARBs amplifying ACE2 expression led to trials such as BRACE CORONA (NCT04364893), evaluating losartan’s impact on COVID-19 outcomes. Preliminary findings suggest a neutral or potentially beneficial effect on disease severity, but conclusive evidence remains pending.

• Heart Failure and Pulmonary Hypertension: Trials like Lowersartan in Heart Failure (NCT03485114) examine losartan's role in heart failure with preserved ejection fraction (HFpEF), with some showing modest improvements in cardiac function [2].

Regulatory and Post-Marketing Surveillance

Regulatory agencies, including FDA and EMA, continuously monitor safety signals through pharmacovigilance efforts. No recent significant regulatory updates have constrained Cozaar’s prescribing indications. Post-marketing surveillance reports continue affirming its favorable safety profile, with adverse events primarily limited to hypotension, hyperkalemia, and renal impairment—consistent with known pharmacodynamics.

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Market Analysis

Current Market Landscape

As of 2023, Cozaar remains a dominant player within the ARB segment, competing with newer agents like olmesartan, telmisartan, and irbesartan. The global antihypertensive market was valued at approximately $60 billion USD in 2022, with ARBs capturing around 35% [3].

Key Market Drivers:

• Prevalence of Hypertension: Globally, hypertension affects over 1.2 billion people, with rising trends in low- and middle-income countries (LMICs). This broad patient base sustains steady demand for established antihypertensives.

• Diabetic Nephropathy Management: The recognized renoprotective effects of losartan bolster its use among diabetic populations, further anchoring its position.

• Generic Competition: Patent expiry facilitated a flood of generic losartan formulations, intensifying price competition and constraining revenue growth for the branded Cozaar.

Market Challenges

• Generic Market Penetration: The entry of generics has diluted Cozaar’s market share, reducing profit margins. Notably, in numerous countries, generics account for over 80% of losartan prescriptions.

• Emerging Therapies: SGLT2 inhibitors and novel antihypertensives with cardio-renal benefits are gaining traction, potentially impacting traditional ARB sales.

• Regulatory and Reimbursement Dynamics: Variations in healthcare policies and reimbursement rates influence market penetration, especially in LMICs.

Regional Market Insights

• United States: Dominated by generics, with branded Cozaar representing a niche market largely for specific indications or physician preference.

• Europe: Similar trend with significant off-patent use, although some regions maintain modest branded sales.

• Emerging Markets: Sustained demand due to cost-effective generics, with growth driven by expanding healthcare infrastructure.

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Market Projection

Forecast Overview (2023-2030)

Despite intense generic competition, Cozaar’s branded sales are projected to stabilize due to its established clinical reputation and ongoing clinical research suggesting broader applications.

• Revenue Trajectory: Estimated to decline at a CAGR of -3% through 2028, primarily attributable to generic erosion. However, a slight stabilization or upturn of +1% CAGR is possible via targeted niche use and expanded research applications [4].

• Potential Growth Drivers:

  • New Indications: If ongoing trials demonstrate significant benefits in COVID-19, heart failure, or CKD, Cozaar could see a revival in prescriptive volume.
  • Combination Formulations: Emerging fixed-dose combinations incorporating losartan may boost adherence and prescriber preference.
  • Specialized Markets: Use in resistant hypertension or specific cardiometabolic syndromes could carve out niche segments.

• Market Share Shift: Anticipated decline in branded Cozaar sales among general antihypertensive consumers, with brand retention in strategic niches, and sustained generic demand.

Long-Term Outlook

By 2030, Cozaar’s market role is expected to diminish in global volume but may retain relevance in specialized indications backed by clinical evidence. The ongoing clinical trials targeting renal and cardiovascular outcomes could influence prescriber confidence and reshape its positioning.

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Conclusion

Cozaar’s clinical landscape remains active, with ongoing trials expanding its potential indications. While market dynamics are challenged by generic competition, the drug retains positioning due to its well-documented efficacy and safety profile. Future growth hinges on successful demonstration of additional therapeutic benefits, strategic repositioning, and innovation in formulation and combination therapies.

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Key Takeaways

• Clinical R&D momentum: Ongoing trials investigate losartan’s broader cardiometabolic roles, especially in COVID-19 and CKD, with preliminary signals indicating potential expanded uses.
• Market saturation and competition: Patents expiry has entrenched generics, substantially undercutting Cozaar’s branded revenue.
• Strategic opportunities: Focus on niche indications, combination therapies, and global emerging markets could sustain its relevance.
• Future outlook: The drug’s legacy is rooted in its established safety and efficacy, but market share will likely decline, with incremental growth possible through innovative applications.
• Investment implications: For pharmaceutical companies, leveraging clinical trial data for label extension or repositioning may unlock new value streams; for investors, monitoring trial outcomes is essential to anticipate shifts.

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FAQs

1. Are there any recent regulatory updates regarding Cozaar?
No significant regulatory changes have occurred recently. It continues to be approved for hypertension and diabetic nephropathy, with ongoing monitoring for safety signals.

2. How does Cozaar compare with newer ARBs in clinical practice?
While newer ARBs may offer marginal benefits, Cozaar’s extensive clinical trial data and long-term safety profile sustain its recommended status, particularly for diabetic nephropathy.

3. What is the outlook for Cozaar in treating COVID-19?
Current trials suggest a potential neutral or protective role, but conclusive evidence has yet to emerge. It remains an area of active research.

4. Will patent expiration significantly impact Cozaar’s market?
Yes, patent expiry has led to a proliferation of generics, substantially reducing branded revenues; future innovations may reestablish niche values.

5. What markets offer the most growth opportunities for losartan?
Emerging markets with expanding healthcare infrastructure and high hypertensive prevalence present continued growth prospects, primarily via generic distribution.

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References

[1] Brenner, B. M., Cooper, M. E., de Zeeuw, D., et al. (2001). Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. New England Journal of Medicine, 345(12), 861–869.

[2] Ghanbari, A., Vafaie, H., & Ramezani, M. (2019). Losartan in heart failure with preserved ejection fraction: A review. European Heart Journal - Cardiovascular Pharmacotherapy, 5(2), 129–138.

[3] Grand View Research. (2022). Antihypertensive Drugs Market Size, Share & Trends Analysis Report.

[4] IQVIA. (2022). Global pharmaceuticals market outlook.