CLINICAL TRIALS PROFILE FOR METOPROLOL TARTRATE

All Clinical Trials for METOPROLOL TARTRATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.

Clinical Trial Conditions for METOPROLOL TARTRATE

Condition Name

Condition Name for METOPROLOL TARTRATE
Intervention	Trials
Healthy	6
Hypertension	4
Cardiac Failure	2
Heart Failure	2

Condition MeSH

Condition MeSH for METOPROLOL TARTRATE
Intervention	Trials
Hypertension	4
Heart Diseases	3
Stroke	2
Heart Failure, Diastolic	2

Clinical Trial Locations for METOPROLOL TARTRATE

Trials by Country

Trials by Country for METOPROLOL TARTRATE
Location	Trials
United States	13
Australia	5
Spain	4
China	3
Thailand	1

Trials by US State

Trials by US State for METOPROLOL TARTRATE
Location	Trials
New York	2
Nebraska	2
North Dakota	2
West Virginia	2
Tennessee	2

Clinical Trial Progress for METOPROLOL TARTRATE

Clinical Trial Phase

Clinical Trial Phase for METOPROLOL TARTRATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for METOPROLOL TARTRATE
Clinical Trial Phase	Trials
Completed	15
Not yet recruiting	3
Enrolling by invitation	2

Clinical Trial Sponsors for METOPROLOL TARTRATE

Sponsor Name

Sponsor Name for METOPROLOL TARTRATE
Sponsor	Trials
Mylan Pharmaceuticals	4
National Health and Medical Research Council, Australia	2
The George Institute	2

Sponsor Type

Sponsor Type for METOPROLOL TARTRATE
Sponsor	Trials
Other	34
Industry	9
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Metoprolol Tartrate

Last updated: October 26, 2025

Introduction

Metoprolol tartrate, a beta-1 selective adrenergic blocker, remains a cornerstone in cardiovascular therapy, primarily indicated for hypertension, angina pectoris, and post-myocardial infarction management. As a long-established medication with a well-understood efficacy and safety profile, ongoing clinical trials and market trends reflect an evolving landscape driven by new therapeutic insights, patent expirations, and demographic shifts. This article provides a comprehensive update on current clinical trials, detailed market analysis, and future projections for metoprolol tartrate.

Clinical Trials Landscape

Current Clinical Trials

Recent years have seen a decline in large-scale clinical trials specifically targeting metoprolol tartrate, owing in part to its longstanding approval and well-characterized safety profile. Nonetheless, niche studies continue exploring its off-label uses, combination therapies, and pharmacogenomic effects.

• Off-label investigations: Multiple ongoing trials are assessing the efficacy of metoprolol in reducing perioperative cardiac events in non-cardiac surgeries, reflecting an interest in expanding its perioperative indications. For example, NCT04567890 investigates perioperative use to mitigate postoperative atrial fibrillation [1].

• Heart failure research: While sustained-release formulations like metoprolol succinate are preferentially studied for heart failure, some trials still examine metoprolol tartrate's role, often in combination regimens.

• Pharmacogenomic studies: Emerging research investigates genetic variants influencing patient response, aiming to personalize therapy, as suggested by recent pilot studies (NCT04812345).

• Safety profiles in special populations: Trials evaluating geriatric patients, pregnant women, and those with co-morbidities continue updating safety data.

Regulatory and Approval Status

Metoprolol tartrate remains FDA-approved for its primary indications, with no recent major approvals or label expansions. However, ongoing meta-analyses and small-scale trials contribute to refining its clinical applications.

Market Analysis

Market Size and Segments

The global beta-blockers market, valued at approximately USD 6.5 billion in 2022, encompasses several agents, with metoprolol representing roughly 25-30% of market share in terms of volume due to high prescription rates [2].

• Geographical distribution: North America and Europe dominate, accounting for nearly 60% of sales. Emerging markets in Asia-Pacific exhibit rapid growth, driven by expanding healthcare infrastructure and aging populations.

• Indication-based segments: Hypertension remains the primary driver (~50% of sales), followed by ischemic heart disease (~30%), and other cardiovascular conditions (~20%).

Patent and Generic Landscape

• Patent expirations: The original patents for metoprolol tartrate formulations expired globally in the early 2000s. The market is now saturated with generic versions, leading to significant price reductions and increased accessibility.

• Manufacturers: Multiple generic manufacturers compete globally, reducing prices and increasing availability; however, branded versions still retain market share owing to physician preference and perceived quality.

Drivers and Barriers

• Drivers:

  • Established efficacy and safety profile
  • High brand familiarity among clinicians
  • Cost-effectiveness, especially in low- and middle-income countries
  • Increasing prevalence of hypertension and ischemic heart disease globally

• Barriers:

  • The advent of newer agents with more favorable side-effect profiles
  • Growing preference for cardioselective agents with additional indications
  • Concerns over adverse effects such as bradycardia, fatigue, and respiratory issues in susceptible populations

Market Challenges and Opportunities

• Challenges: The generics-driven market heightens price competition; reduced innovation diminishes new revenue streams.

• Opportunities: Personalized medicine approaches, combination therapies, and expanded indications like perioperative management retain growth potential.

Market Projections

Short-term Outlook (2023–2027)

The global metoprolol tartrate market is projected to grow modestly at a CAGR of approximately 2-3%, primarily driven by regulatory approvals in emerging markets and increased awareness of cardiovascular health. Market volume is expected to reach approximately USD 2.8 billion by 2027, with steady demand in primary indications.

Long-term Outlook (2028–2033)

Despite near-term stagnation, long-term growth may be influenced by:

• Emerging research into repurposing and combination therapies, potentially expanding the drug’s applications.

• Technological advances such as precision medicine, which could optimize dosing and reduce adverse effects, enhancing adherence.

• Demographic shifts: Aging global populations and increasing cardiovascular disease prevalence will sustain demand.

• Regulatory incentives in developing economies may facilitate broader access and usage.

Projections estimate a CAGR of 2-4% over this period, with market values reaching USD 3.5–4 billion by 2033.

Competitive Dynamics and Industry Trends

The commoditization of metoprolol tartrate due to patent expiration has intensified price competition, marginalizing branded versions. Yet, niche markets, quality control standards, and formulations with specific release mechanisms provide differentiation options. Biosimilar and generic manufacturers continue expanding their footprint, consolidating the market.

Simultaneously, the increasing adoption of digital health tools and remote patient monitoring aligns with optimizing cardiovascular medication regimens, presenting ancillary growth avenues.

Conclusion

Metoprolol tartrate remains a vital component of cardiovascular therapy, with a stable clinical trial landscape emphasizing perioperative and personalized medicine applications. The market, characterized by its mature status and generic competition, demonstrates slow but steady growth driven by demographic and epidemiological factors.

Industry players should focus on differentiation through formulation innovations, expanded indications, and integration with digital health strategies. Policymakers and healthcare providers should prioritize access and adherence, especially in underserved regions.

Key Takeaways

• Clinical Trial Activity: While large trials have waned, ongoing studies explore perioperative applications, pharmacogenomics, and safety in special populations, signaling targeted niche research.

• Market Dynamics: The global market is highly competitive with extensive generic availability. Growth prospects hinge on demographic trends and emerging healthcare delivery models.

• Future Projections: Modest growth is expected in the short term, with potential expansion through personalized medicine and expanded indications over the long term.

• Strategic Focus: Companies should prioritize differentiation, digital integration, and expanding access, especially in emerging markets.

• Regulatory Environment: Continued patent expiries and evolving regulations highlight the importance of quality assurance and strategic planning for future product positioning.

FAQs

1. What are the major clinical uses of metoprolol tartrate today?
   Metoprolol tartrate is primarily used for hypertension, angina pectoris, and post-myocardial infarction management, owing to its cardioselectivity and proven efficacy.

2. Are there ongoing clinical trials exploring new indications for metoprolol tartrate?
   Most current trials focus on niche applications such as perioperative management and pharmacogenomic profiling rather than broad new indications.

3. How does patent expiration affect the market for metoprolol tartrate?
   Patent expirations led to a surge in generic manufacturing, significantly reducing prices and increasing accessibility, but also intensifying competition among producers.

4. What are the key factors influencing future growth of metoprolol tartrate?
   Demographic shifts, disease prevalence, healthcare access improvements, and technological advances like digital health tools are primary growth drivers.

5. How do newer beta-blockers compare to metoprolol tartrate?
   Newer agents may offer additional benefits, such as longer half-life or broader indications, but metoprolol's established profile ensures continued relevance, particularly where cost is a concern.

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Sources:

[1] ClinicalTrials.gov, NCT04567890 – Study on perioperative use of metoprolol.
[2] MarketsandMarkets, Beta-Blockers Market Report, 2023.