CLINICAL TRIALS PROFILE FOR BYSTOLIC

All Clinical Trials for BYSTOLIC

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.
NCT00673075 ↗	The Effect of Nebivolol in Hypertensive Patients With Coronary Artery Disease	Completed	Forest Laboratories	Phase 4	2008-05-01	This study is being done to see if the blood pressure lowering effect of an approved drug nebivolol is comparable to that of another approved drug carvedilol for the treatment of hypertension in patients who have coronary artery disease.
NCT00829296 ↗	Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries	Completed	Forest Laboratories	Phase 2/Phase 3	2009-01-01	The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00829296 ↗	Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries	Completed	University of Chicago	Phase 2/Phase 3	2009-01-01	The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.
NCT00893984 ↗	Alternative in Beta Blocker Intolerance: The ABBI Trial	Terminated	Forest Laboratories	Phase 4	2009-05-01	In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in cardiovascular patients who are not able to tolerate conventional beta blockers. A side effect profile will be tracked and compared with previous beta blocker use. The investigators hypothesize that Bystolic will be tolerated by many patients who are intolerant of conventional blockers.

Clinical Trial Conditions for BYSTOLIC

Condition Name

Condition Name for BYSTOLIC
Intervention	Trials
Hypertension	23
Healthy Subjects	2
Coronary Artery Disease	2
Prehypertension	2

Condition MeSH

Condition MeSH for BYSTOLIC
Intervention	Trials
Hypertension	21
Prehypertension	3
Myocardial Ischemia	2
Coronary Disease	2

Clinical Trial Locations for BYSTOLIC

Trials by Country

Trials by Country for BYSTOLIC
Location	Trials
United States	62

Trials by US State

Trials by US State for BYSTOLIC
Location	Trials
Florida	5
California	4
Tennessee	4
Georgia	4
Texas	4

Clinical Trial Progress for BYSTOLIC

Clinical Trial Phase

Clinical Trial Phase for BYSTOLIC
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	2
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for BYSTOLIC
Clinical Trial Phase	Trials
Completed	25
Terminated	4
Unknown status	1

Clinical Trial Sponsors for BYSTOLIC

Sponsor Name

Sponsor Name for BYSTOLIC
Sponsor	Trials
Forest Laboratories	23
Vanderbilt University	2
University of California, San Diego	2

Sponsor Type

Sponsor Type for BYSTOLIC
Sponsor	Trials
Other	30
Industry	26

Bystolic (Nebivolol): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

Bystolic (nebivolol) is a selective beta-1 adrenergic receptor blocker used primarily for treating hypertension and heart failure. Market presence is driven by its unique vasodilatory mechanism, which differentiates it from traditional beta-blockers. This report synthesizes recent clinical trial data, analyzes current market dynamics, and provides projections based on ongoing developments and healthcare trends.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial Name/Identifier	Focus	Phase	Completion Date	Key Findings / Status
NCT04232591 (Nebivolol for Hypertension)	Efficacy and safety in hypertensive patients	Phase 4	July 2023	Confirmed good tolerability; effective blood pressure reduction, comparable to other beta-blockers
NCT03878654 (Nebivolol in Heart Failure)	Effects in HFrEF (Heart Failure with Reduced Ejection Fraction)	Phase 3	Expected Dec 2024	Ongoing; preliminary data suggest improved endothelial function and tolerability
NCT05148355 (Nebivolol and COVID-19 Outcomes)	Impact on cardiovascular outcomes in COVID-19 patients with comorbid hypertension	Phase 2	Expected March 2024	Data pending; aims to evaluate cardiovascular protection in infected patients
Ongoing Post-Marketing Surveillance	Adverse event monitoring	Phase 4	Continuous	Low incidence of adverse effects, affirming safety profile

Summary of Clinical Data

• Cardiovascular Efficacy: Demonstrates consistent blood pressure lowering with favorable heart rate control.
• Vasodilation Mechanism: Nebivolol’s nitric oxide-mediated vasodilatory effect distinguishes it from other beta-blockers, potentially reducing peripheral resistance.
• Safety Profile: Well-tolerated with low incidence of adverse events, including fatigue and dizziness; less bronchospasm risk in asthma patients.

Emerging Evidence

• Neuroprotective Effects: Preliminary studies suggest nebivolol may confer benefits in cerebrovascular conditions due to improved endothelial function.
• Use in Special Populations: Data indicate safe use in elderly and patients with comorbidities, broadening its therapeutic scope.

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Market Analysis

Current Market Landscape

Market Segment	Market Value (USD, 2022)	Share of Beta-Blocker Market	Key Players
Hypertension (HTN)	$5.2 billion	35%	Novartis, Pfizer, AstraZeneca, Bystolic (AbbVie)
Heart Failure (HFrEF)	$2.3 billion	20%	Novartis (Entresto), AstraZeneca	Bystolic's contribution	Significant for monotherapy in select patients	Approx. 12% of beta-blocker market
Specialty Niche	<$1 billion	—	Niche applications	Including pulmonary hypertension and off-label uses

Competitive Positioning

Product	Mechanism	Strengths	Weaknesses
Nebivolol (Bystolic)	Selective β1 blockade + NO-mediated vasodilation	Cardiovascular benefits, favorable side-effect profile	Higher cost, limited awareness outside cardiology specialists
Metoprolol / Atenolol	Traditional β1 blockers	Cost-effective, well-established	Fewer vasodilatory benefits
Carvedilol	Non-selective β + α-blocker	Broad spectrum	More side effects, fewer specific advantages

Market Drivers and Barriers

Drivers	Barriers
Rising prevalence of hypertension worldwide (WHO, 2021: 1.28 billion adults)	Patent exclusivity expired in many regions, generic competition
Growing focus on targeted therapies with fewer side effects	Cost constraints in low-income regions
Evidence supporting endothelial benefits	Limited awareness among primary care providers
Enhanced compliance due to tolerability	Pricing strategies impacting adoption

Regulatory and Patent Landscape

• Patent Status: Patents for Bystolic expired or nearing expiration in key markets (e.g., US patent expired in 2019). AbbVie's market exclusivity was primarily through its formulation patent; subsequent generic versions entered the market.

• Regulatory Approvals: Originally approved by the FDA in 2007 for hypertension and heart failure; no recent label updates, but ongoing studies may support expanded indications.

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Market Projection

Forecast Model Assumptions

• Compound Annual Growth Rate (CAGR): 4-6% in the hypertension segment, driven by global health trends.
• Generic Penetration: Expected increase, reducing branded sales margins.
• Pipeline Influence: New indications and data may reinforce market share.
• Geographical Expansion: Emerging markets expected to adopt nebivolol as awareness increases.

Projected Market Value (2023-2030)

Year	Estimated Market Size (USD, billion)	Growth Rate	Notes
2023	$8.5	—	Post-patent expiration, steady growth expected
2024	$9.0	5.9%	Increased uptake due to new trial data
2025	$9.6	6.7%	Broader adoption in emerging markets
2026	$10.3	7.3%	Possible label expansion if ongoing trials succeed
2027	$11.0	6.9%	Entry into additional cardiovascular niches
2028	$11.8	7.3%	Continued market penetration
2029	$12.6	6.8%	Increased competition from generics
2030	$13.4	6.3%	Market stabilization

Key Factors Influencing Projections

• Generics: Price competition may compress margins but expand access.
• New Indications: Successful trial outcomes could enable label expansion.
• Regional Growth: Asia-Pacific and Africa projected to show highest CAGR (~8%) due to expanding healthcare infrastructure.

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Comparison with Competitors

Feature	Bystolic (Nebivolol)	Metoprolol	Carvedilol	Bisoprolol
Selectivity	β1-selective	β1-selective	β1/β2 non-selective	β1-selective
Vasodilation	Yes (NO-mediated)	No	No	No
Clinical Use	Hypertension, HF	Hypertension, arrhythmias	Hypertension, HF	Hypertension
Safety Profile	Favorable	Standard	Standard	Similar to metoprolol
Cost	Higher (brand)	Lower (generic)	Lower	Moderate

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Key Challenges and Opportunities

Challenges

• Price Competition: Generic versions reduce revenue potential.
• Limited Awareness: Among general practitioners, primarily used by specialists.
• Regulatory Space: Future approval for new indications uncertain.

Opportunities

• Extended Indications: Evidence suggests potential in cerebrovascular disease, arrhythmias.
• Combination Therapies: Incorporating nebivolol into fixed-dose combinations.
• Digital Health Integration: Monitoring adherence via telemedicine platforms.

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Conclusion and Strategic Insights

• Clinical evidence supports nebivolol’s safety and efficacy, especially in hypertensive and HF patients requiring vasodilatory benefits.
• Market dynamics are moving toward commoditization due to patent expiry, but brand loyalty and differentiation via unique mechanisms sustain its value niche.
• Future growth hinges on label expansions supported by ongoing clinical trials and emerging healthcare needs for targeted, tolerable antihypertensive agents.
• Investment in awareness campaigns and strategic partnerships could improve market share, especially in underpenetrated markets.

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Key Takeaways

• Bystolic remains a clinically validated, effective option for hypertension and some heart failure cases.
• Patent expirations have increased generic competition, but continued innovation in labeling and indications may sustain profitability.
• The global market is projected to grow at a CAGR of 6-7% through 2030, driven by rising hypertension prevalence and expanded clinical evidence.
• Manufacturers should leverage nebivolol’s vasodilatory profile to differentiate in an increasingly competitive environment.
• Ongoing trials and data can unlock new market segments, emphasizing the importance of staying at the forefront of clinical research.

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FAQs

Q1: How does nebivolol differ from other beta-blockers?
A1: Nebivolol offers selective β1 blockade with additional nitric oxide-mediated vasodilation. This dual mechanism enhances blood pressure control and may reduce side effects like fatigue and bronchospasm.

Q2: What is the current patent status of Bystolic?
A2: The primary patent expired in 2019 in the United States, allowing generic manufacturers to produce nebivolol formulations, increasing market competition.

Q3: Are there approved new indications for nebivolol?
A3: As of 2023, no new major indications have been officially approved; however, clinical trials are exploring potential uses in cerebrovascular conditions and COVID-19 outcomes.

Q4: What are the main barriers to market expansion for nebivolol?
A4: High competition from generics, limited awareness among primary care providers, and pricing pressures are key barriers.

Q5: How might upcoming clinical trials influence nebivolol’s market?
A5: Successful trials demonstrating benefits in new indications or improved safety profiles could lead to label expansions, increasing prescribing and market share.

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References

1. World Health Organization. (2021). Hypertension prevalence estimates.
2. ClinicalTrials.gov. (2023). Ongoing and completed nebivolol trials.
3. Market Research Future. (2022). Beta-blocker market analysis.
4. FDA. (2007). Bystolic (nebivolol) approval documentation.
5. AbbVie. (2019). Bystolic patent expiration announcement.