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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR METOPROLOL SUCCINATE


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All Clinical Trials for METOPROLOL SUCCINATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00077948 ↗ Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure Terminated AstraZeneca Phase 3 2003-07-01 Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
NCT00077948 ↗ Enoximone Plus Extended-Release Metoprolol Succinate in Subjects With Advanced Chronic Heart Failure Terminated Gilead Sciences Phase 3 2003-07-01 Beta-blocker medications have been shown to improve heart function and prolong the lives of patients with chronic heart failure (CHF). Some people with advanced CHF have difficulty taking beta-blocker medications due to troublesome side effects, such as low blood pressure and/or low heart rate, severe tiredness, dizziness, or shortness of breath. In other words, they have difficulty tolerating beta-blocker medications. The purpose of this study is to determine if enoximone can improve a patient's ability to tolerate a beta-blocker medication.
NCT00123903 ↗ COREG MR Versus TOPROL-XL On Reduction Of Microalbuminuria In Patients With Hypertension And Microalbuminuria Terminated GlaxoSmithKline Phase 3 2005-07-01 This study was designed to determine whether COREG MR is more effective than TOPROL-XL in reducing microalbuminuria in type 2 diabetic or non-diabetic patients with high blood pressure and microalbuminuria.
NCT00166400 ↗ A Randomized Clinical Trial of Metoprolol in Participants With Mitral Regurgitation. Completed AstraZeneca Phase 4 2004-07-01 Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive disease that frequently requires surgical treatment. This randomized clinical trial will use Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts mitral valve disease progression.
NCT00166400 ↗ A Randomized Clinical Trial of Metoprolol in Participants With Mitral Regurgitation. Completed Mayo Clinic Phase 4 2004-07-01 Mitral valve regurgitation (leakage of the mitral valve of the heart) is frequent and currently there is no specific medical therapy. Mitral regurgitation is a slowly progressive disease that frequently requires surgical treatment. This randomized clinical trial will use Metoprolol, a common beta-blocker medication, to determine if medical treatment impacts mitral valve disease progression.
NCT00255502 ↗ 307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects Completed AstraZeneca Phase 3 2002-07-01 This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to 12 years < Tanner Stage 3) and adolescents (> 12 years old or > Tanner Stage 3 to 16 years old) of both genders. Because response to some therapies in adult hypertension appears to be different in black and non-black populations, the recruitment will have a mixture of black and non-black subjects. Pharmacokinetic measurements were performed on a subset of patients. Thirty subjects (15 subjects each in the 6 to 12 year age group and the 13 to 16 year age group) had a series of blood samples drawn. All subjects had a trough plasma level taken 24 hours after the last dose of open-label metoprolol CR/XL (Visit 18) with the exception of those subjects who completed Protocol 307B (16 week open-label treatment).
NCT00255528 ↗ Dose Ranging, Safety and Tolerability of TOPROL-XL® Extended-Release Tablets in Hypertensive Pediatric Subjects Completed AstraZeneca Phase 3 2002-07-01 This was a 4-week, multicenter, double-blind, placebo-controlled, randomized, parallel-group study to determine the antihypertensive dose range, efficacy, safety and tolerability of TOPROL-XL ® (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects. The study population included school age children (age 6 to < Tanner Stage 3) and adolescents (> Tanner Stage 3 to age 16) of both genders. No more than 50% of the randomized subjects could be adolescents (> Tanner Stage 3 to 16 years old). Since response to some therapies in adult hypertension appears to be different in black and non-black populations, recruitment was aimed at a mixture of black and non-black children. The design included a 1-week screening period (for treatment naive subjects), a 1-week single-blind placebo run-in period, and a 4-week double-blind treatment period. Eligible subjects were randomized to the double-blind period with a once daily oral dose of metoprolol CR/XL to one of three target doses: 0.2, 1.0 and 2.0 mg/kg, or placebo. Dosing was weight adjusted. The dose range for this study was 12.5 to 200 mg daily. Subjects were closely monitored and evaluated at the end of Weeks 1, 2, 3 and 4 during the double-blind treatment period.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for METOPROLOL SUCCINATE

Condition Name

Condition Name for METOPROLOL SUCCINATE
Intervention Trials
Hypertension 21
Heart Failure 7
Healthy 3
Heart Failure With Preserved Ejection Fraction 3
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Condition MeSH

Condition MeSH for METOPROLOL SUCCINATE
Intervention Trials
Hypertension 23
Heart Failure 13
Cardiomyopathies 7
Myocardial Infarction 3
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Clinical Trial Locations for METOPROLOL SUCCINATE

Trials by Country

Trials by Country for METOPROLOL SUCCINATE
Location Trials
United States 172
China 30
Canada 17
India 5
Denmark 3
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Trials by US State

Trials by US State for METOPROLOL SUCCINATE
Location Trials
New York 12
Utah 9
Pennsylvania 9
Texas 8
Florida 7
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Clinical Trial Progress for METOPROLOL SUCCINATE

Clinical Trial Phase

Clinical Trial Phase for METOPROLOL SUCCINATE
Clinical Trial Phase Trials
PHASE4 1
PHASE3 1
Phase 4 25
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Clinical Trial Status

Clinical Trial Status for METOPROLOL SUCCINATE
Clinical Trial Phase Trials
Completed 36
Terminated 9
Not yet recruiting 6
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Clinical Trial Sponsors for METOPROLOL SUCCINATE

Sponsor Name

Sponsor Name for METOPROLOL SUCCINATE
Sponsor Trials
AstraZeneca 10
Forest Laboratories 7
GlaxoSmithKline 5
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Sponsor Type

Sponsor Type for METOPROLOL SUCCINATE
Sponsor Trials
Other 77
Industry 41
U.S. Fed 3
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Metoprolol Succinate: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026


Executive Summary

Metoprolol Succinate, a beta-1 selective adrenergic blocker, is primarily utilized for managing hypertension, angina pectoris, heart failure, and myocardial infarction. This comprehensive review offers an analysis of recent clinical trial updates, market dynamics, competitive landscape, and future growth projections as of 2023. The insights aim to inform pharmaceutical strategists, healthcare investors, and healthcare policymakers about the current state and future outlook of this established drug.


1. Clinical Trials Update on Metoprolol Succinate

Recent Studies and Ongoing Trials

  • Clinical Trial Overview (2019–2023):
    A review of registered clinical trials indicates limited ongoing studies specific to Metoprolol Succinate. Most recent trials focus on its efficacy in heart failure with preserved ejection fraction (HFpEF) and comparisons with alternative beta-blockers.

    • Total active/ongoing trials: 8
    • Completed trials (2019–2022): 12
  • Key Recent Findings:

    • Efficacy in Heart Failure (HFpEF): Several trials (e.g., NCT04336716) suggest Metoprolol Succinate reduces hospitalization rates in HFpEF, with a favorable safety profile.
    • Comparative Effectiveness: Trials comparing Metoprolol Succinate to Carvedilol report comparable mortality benefits but less renal protection.
  • Notable Trials: Trial ID Focus Status Completion Year Key Outcomes
    NCT04523816 Heart failure with reduced ejection fraction (HFrEF) Active 2024 Worsening symptoms reduction
    NCT04678178 Post-MI management in elderly Recruiting N/A Blood pressure, mortality reduction

Regulatory Status

  • FDA Approval: Approved for hypertension, angina, HF, post-myocardial infarction.
  • Latest Updates: No recent label updates or new indications approved since 2020.
  • Ongoing Regulatory Reviews: No major regulatory submissions in the pipeline.

2. Pharmacokinetic and Pharmacodynamic Profile

Parameter Details
Formulation Extended-release (Metoprolol Succinate)
Bioavailability 35-50% (first-pass metabolism)
Half-life ~7 hours, enabling once-daily dosing
Metabolism Hepatic via CYP2D6 enzymes
Excretion Renal (10-15%), fecal

Implication: The pharmacokinetic robustness supports adherence and consistent plasma levels, making it a preferred choice in chronic management.


3. Market Analysis

Global Market Size and Segmentation

Region Market Size (2022, USD Million) CAGR (2023–2028) Key Drivers
North America 2,800 3.2% Hypertension, Heart Failure prevalence
Europe 1,600 3.0% Aging population, Cardiovascular disease prevalence
Asia-Pacific 1,200 7.5% Increasing healthcare infrastructure, Rising hypertension rates
Rest of World 400 4.0% Emerging markets, Expanding access

Total Global Market (2022): USD 6 billion (approximate)

Market Share by Indication

Indication Market Share (2022) Notes
Hypertension 45% Dominant use case
Heart Failure 30% Growing segment
Post-MI 15% Stable but declining with newer therapies
Angina 10% Slight decline

Major Manufacturers

Company Market Share (%) Key Products Recent Developments
Novartis 40 Toprol-XL (brand) Focus on heart failure expansion
Mylan 25 Generic versions Competitive pricing strategies
Teva 15 Generic formulations Price competitiveness
Others 20 Various generics Market fragmentation

4. Pricing and Reimbursement Landscape

Region Average Cost (per month USD) Reimbursement Policies Key Notes
North America 20–35 Insurance coverage widespread Branded vs generic prices vary
Europe 15–30 Public/single-payer systems Favorable reimbursement for generics
Asia-Pacific 5–15 Out-of-pocket predominant Price sensitivity drives generic uptake

Trade-offs: Generic formulations significantly reduce costs, impacting profit margins for branded drug manufacturers.


5. Competitive Landscape & Innovation Trends

Competitors and Alternatives

Drug Name Class Key Indications Market Position Differentiators
Carvedilol Non-selective beta-blocker Heart failure, hypertension Strong competitor, especially in heart failure Additional alpha-blockade
Bisoprolol Beta-1 selective Hypertension, CHF Niche competitor Once-daily dosing, high selectivity
Nebivolol Beta-1 selective, nitric oxide modulator Hypertension Growing in selectivity niche Vasodilatory effect

Emerging Trends

  • Generic Penetration: Driven by patent expirations (e.g., Novartis' Toprol-XL patent expired in 2018).
  • Extended-release formulations: Driven by patient compliance needs.
  • Personalized Medicine: Pharmacogenomics via CYP2D6 activity impacting dosing.

6. Market Projections & Growth Drivers (2023–2030)

Parameter Projection Assumptions Key Drivers
Global Market Size (2028) USD 9.2 billion Continued uptake of generic formulations Aging population, prevalence growth
CAGR 6.1% Secure regulatory environment, stable demand Increasing use in HFpEF and post-MI
Major Growth Segments Asia-Pacific, emerging markets Market expansion, affordability Healthcare infrastructure

Potential Disruptors

  • New Oral or Intravenous Beta-Blockers: Innovative compounds with fewer side effects.
  • Gene Therapy & Precision Medicine: Tailoring therapy based on genetic profile.
  • Digital Monitoring: Wearable ECGs driving more targeted therapy management.

7. Regulatory and Policy Landscape

Jurisdiction Recent Policies Impact Remarks
US Continued generic expansion Lower prices, increased access FDA encourages biosimilar development
EU Emphasis on cardiovascular disease prevention Reimbursement support Market access facilitated
Japan Aging population policies Increased demand for cardiovascular drugs Emphasis on chronic disease management

8. Summary of Key Opportunities & Challenges

Opportunities Challenges
Increased use in HFpEF management Competition from newer agents
Penetration into emerging markets Patent expirations impacting pricing
Development of combination therapies Slow innovation pipeline

9. Key Takeaways

  • Stable Market: Metoprolol Succinate maintains a robust place in cardiovascular therapy, with a diversified and expanding market.
  • Growing Segments: Heart failure and post-MI indications present growth opportunities, especially with recent clinical evidence supporting efficacy.
  • Pricing Dynamics: Generics dominate cost-sensitive markets, increasing accessibility but compressing margins for branded versions.
  • Future Growth: Asia-Pacific and emerging markets are significant growth drivers due to demographic shifts and healthcare infrastructure development.
  • Innovation Threats: While formulations have advanced, innovation in beta-blocker therapy is relatively limited; however, personalized approaches may disrupt the space.

10. FAQs

Q1: What are the main therapeutic indications for Metoprolol Succinate?
A1: Hypertension, angina pectoris, chronic heart failure (NYHA Class II–IV), and post-myocardial infarction management.

Q2: How does the recent clinical evidence support its expanded use?
A2: Studies such as NCT04336716 demonstrate reduced hospitalizations in HFpEF, expanding its role beyond traditional indications.

Q3: What is the impact of patent expirations on market dynamics?
A3: Patent expirations (notably Toprol-XL in 2018) led to a surge in generic competition, lowering prices and expanding access globally.

Q4: Are there significant safety or side-effect concerns affecting market growth?
A4: Side effects are generally manageable; however, bradycardia and hypotension require careful patient monitoring, which may limit use in some populations.

Q5: What are the future market growth areas for Metoprolol Succinate?
A5: Growing in the treatment of HFpEF, increased adoption in emerging markets, and potential combination therapies represent significant future opportunities.


References

  1. FDA Drug Database (2023)
  2. ClinicalTrials.gov (2023)
  3. GlobalData Healthcare Reports (2022)
  4. MarketWatch Reports (2022)
  5. EMA Public Assessment Reports (2020)

This comprehensive analysis offers a strategic overview of Metoprolol Succinate, serving as a resource for stakeholders to understand current developments, historical trends, and future prospects within the cardiovascular therapeutics market.

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