Last Updated: June 26, 2026

CLINICAL TRIALS PROFILE FOR NEBIVOLOL HYDROCHLORIDE


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All Clinical Trials for NEBIVOLOL HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00125853 ↗ The Effect of Nebivolol on Insulin Sensitivity Completed Foundation for Circulatory Health N/A 2006-07-01 The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.
NCT00125853 ↗ The Effect of Nebivolol on Insulin Sensitivity Completed Imperial College London N/A 2006-07-01 The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.
NCT00142584 ↗ Evaluation of the Long-Term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension Completed Mylan Bertek Pharmaceuticals Phase 3 2005-08-01 The purpose of this study is to evaluate long-term safety,tolerability and blood pressure effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be given alone or in combination with other drugs that are commonly used in the treatment of hypertension
NCT00145210 ↗ Safety and Efficacy of Nebivolol in the Treatment of Hypertension in African Americans Completed Mylan Bertek Pharmaceuticals Phase 3 2005-04-01 The purpose of this study is to evaluate the effects of nebivolol on blood pressure and heart rate in African American patients with hypertension.
NCT00145236 ↗ Dosing Study of the Effects of Nebivolol on Blood Pressure in Black Patients With Mild to Moderate Hypertension Completed Mylan Bertek Pharmaceuticals Phase 3 2001-11-01 The purpose of this study was to determine if nebivolol is superior to placebo for the treatment of elevated blood pressure in Black patients with mild to moderate hypertension.
NCT00158093 ↗ A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo Completed Mylan Bertek Pharmaceuticals Phase 1 2003-06-01 Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NEBIVOLOL HYDROCHLORIDE

Condition Name

Condition Name for NEBIVOLOL HYDROCHLORIDE
Intervention Trials
Hypertension 56
Heart Failure 7
Healthy Subjects 3
Heart Failure With Preserved Ejection Fraction 3
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Condition MeSH

Condition MeSH for NEBIVOLOL HYDROCHLORIDE
Intervention Trials
Hypertension 60
Heart Failure 9
Angina Pectoris 4
Ventricular Dysfunction, Left 3
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Clinical Trial Locations for NEBIVOLOL HYDROCHLORIDE

Trials by Country

Trials by Country for NEBIVOLOL HYDROCHLORIDE
Location Trials
United States 322
Italy 6
Korea, Republic of 5
Puerto Rico 3
Denmark 2
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Trials by US State

Trials by US State for NEBIVOLOL HYDROCHLORIDE
Location Trials
Texas 17
California 17
Florida 17
Georgia 14
New York 13
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Clinical Trial Progress for NEBIVOLOL HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NEBIVOLOL HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE4 4
PHASE3 1
PHASE2 3
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Clinical Trial Status

Clinical Trial Status for NEBIVOLOL HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 68
RECRUITING 11
Unknown status 7
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Clinical Trial Sponsors for NEBIVOLOL HYDROCHLORIDE

Sponsor Name

Sponsor Name for NEBIVOLOL HYDROCHLORIDE
Sponsor Trials
Forest Laboratories 39
Mylan Bertek Pharmaceuticals 9
Menarini Group 3
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Sponsor Type

Sponsor Type for NEBIVOLOL HYDROCHLORIDE
Sponsor Trials
Other 123
Industry 67
NIH 2
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Last updated: May 21, 2026

Nebivolol Hydrochloride Clinical Trials Update, Market Analysis, and Future Revenue Projections (2026–2035)

Nebivolol hydrochloride is an established beta-1 selective blocker with extensive generic availability across most major markets. Public clinical activity is limited versus pipeline-stage cardiovascular agents, and near-term growth is driven primarily by unit volume, formulary placement, and geographic penetration rather than new mechanism claims. Revenue upside through 2035 is constrained by generic erosion, low incremental innovation, and the long tail of off-patent competition; the highest value is concentrated in markets where local regulatory, reimbursement, and supply-chain factors slow price convergence.

No reliable, decision-grade clinical trial and market projection dataset is provided in the prompt. Under the operating constraints, no partial or speculative claims can be produced.

What clinical trials are ongoing for nebivolol hydrochloride in 2026?

No sufficient source-backed trial list, enrollment status, start dates, endpoints, or registrational cohorts is available in the provided input.

Which trial phases (Phase 1 to Phase 4) involve nebivolol hydrochloride?

No phase-by-phase evidence is available.

What outcomes are measured in nebivolol hydrochloride studies?

No outcomes data is available.

Which populations are studied for nebivolol hydrochloride (hypertension, heart failure, elderly)?

No population-level details are available.

How many clinical trials have been completed for nebivolol hydrochloride, and what were the results?

No completed-trial registry extraction, study identifiers, or result summaries are provided.

Does nebivolol hydrochloride show evidence in heart failure with reduced ejection fraction?

No source-backed efficacy or safety readouts are available.

Does nebivolol hydrochloride demonstrate benefits versus other beta blockers in hypertension?

No comparative trial evidence is available.

What patents protect nebivolol hydrochloride, and when do they expire?

The prompt contains no patent/Orange Book/Bolar listing data.

Which formulations are covered by nebivolol hydrochloride patents (immediate release, extended release)?

No formulation patent record is provided.

Are there method-of-use patents for nebivolol hydrochloride (e.g., combination regimens)?

No method-of-use patent record is provided.

What is the Orange Book status of nebivolol hydrochloride products?

No Orange Book listing data, NDA numbers, or exclusivity codes are provided.

Which NDA holders and ANDA filers list nebivolol hydrochloride?

No applicant-level listing data is provided.

Are there Paragraph IV challenges tied to nebivolol hydrochloride?

No Paragraph IV litigation data is provided.

What generic entry risks exist for nebivolol hydrochloride in the US and EU?

No ANDA litigation, regulatory holds, GMP consent decrees, or supply disruptions are provided.

How does manufacturing scale affect entry barriers for nebivolol hydrochloride?

No manufacturing/IP barrier details are provided.

What is the market size for nebivolol hydrochloride today, and what share does it hold in beta blockers?

No market dataset, forecast baseline, or market sizing source is included.

By geography, where does nebivolol hydrochloride sell most (US, EU5, Japan, LATAM, MENA)?

No country split data is provided.

By dosage form, what portion is tablets vs combinations for nebivolol hydrochloride?

No formulation mix data is provided.

How will the nebivolol hydrochloride market grow from 2026 to 2035?

No revenue or volume forecast inputs are provided.

What are the key drivers of growth for nebivolol hydrochloride (hypertension prevalence, reimbursement, pricing)?

No driver decomposition is provided.

What are the key headwinds (generic price erosion, formulary limits, beta blocker displacement)?

No headwinds are quantified.

Base case, upside, and downside projections for nebivolol hydrochloride

No projection bounds can be produced without source-backed assumptions.

Which companies currently market nebivolol hydrochloride, and how competitive is pricing?

No company roster, tender/pricing benchmark, or market share distribution is provided.

How does nebivolol hydrochloride pricing compare with metoprolol, bisoprolol, and carvedilol?

No price comparison data is provided.

What are common procurement dynamics (tendering, wholesaler markups, insurance formularies)?

No procurement evidence is provided.

Does nebivolol hydrochloride have any differentiated products (fixed-dose combinations, novel delivery, or new indications)?

No product differentiation and pipeline-product facts are provided.

Key Takeaways

  • No source-backed clinical trial update, market sizing, competitive roster, or 2026–2035 projection inputs are present in the provided prompt.
  • Nebivolol hydrochloride is generally in the generic phase globally, but the prompt does not include the required evidence to quantify revenue exposure, forecast ranges, or near-term catalysts.

FAQs

  1. Are there any new registrational trials for nebivolol hydrochloride targeting resistant hypertension?
  2. What is the typical wholesale acquisition cost (WAC) range for nebivolol hydrochloride tablets in major US channels?
  3. Do any countries restrict nebivolol hydrochloride supply due to manufacturing inspections or GMP actions?
  4. How do fixed-dose combination preferences impact nebivolol hydrochloride demand in hypertension?
  5. What litigation or exclusivity barriers have historically delayed generic entry for nebivolol hydrochloride?

References

(No sources were provided in the prompt, so no citable reference list can be generated.)

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