CLINICAL TRIALS PROFILE FOR NADOLOL

All Clinical Trials for NADOLOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00390546 ↗	Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia	Completed	The Hospital for Sick Children	Phase 3	2006-10-01	This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently. Specific aims of the study: To determine whether propranolol and digoxin differ in the: 1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin 2. Time to first recurrence of SVT in infants treated with propranolol or digoxin. 3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.
NCT00390546 ↗	Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia	Completed	University of Utah	Phase 3	2006-10-01	This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently. Specific aims of the study: To determine whether propranolol and digoxin differ in the: 1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin 2. Time to first recurrence of SVT in infants treated with propranolol or digoxin. 3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.
NCT00390546 ↗	Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia	Completed	University of British Columbia	Phase 3	2006-10-01	This is a randomized, double-blind, multi-centered study to compare 6 months of medical treatment with digoxin or propranolol in infants with SVT Background: SVT is the most common sustained arrhythmia of infancy. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently. Specific aims of the study: To determine whether propranolol and digoxin differ in the: 1. Incidence of recurrent SVT in infants after 6 months of treatment with propranolol or digoxin 2. Time to first recurrence of SVT in infants treated with propranolol or digoxin. 3. Incidence of adverse outcomes in infants treated with propranolol or digoxin.
NCT00450164 ↗	Secondary Prophylaxis After Variceal Bleeding in Non-Responders	Completed	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Phase 4	2000-11-01	Controlled and randomized study comparing combined treatment (nadolol and endoscopic ligation) versus nadolol associated with isosorbide mononitrate or prazosin according to hemodynamic response, in the prevention of esofagic verices rebleeding.
NCT00567216 ↗	Endoscopic Cyanoacrylate Obliteration vs. Nadolol Treatment in the Prevention of Gastric Variceal Rebleeding	Unknown status	National Science Council, Taiwan	Phase 4	2007-04-01	Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.

Clinical Trial Conditions for NADOLOL

Condition Name

Condition Name for NADOLOL
Intervention	Trials
Cardiac Failure	2
Gastrointestinal Hemorrhage	2
Variceal Bleeding	2
Healthy	2

Condition MeSH

Condition MeSH for NADOLOL
Intervention	Trials
Hypertension	5
Hemorrhage	4
Hypertension, Portal	3
Migraine Disorders	3

Clinical Trial Locations for NADOLOL

Trials by Country

Trials by Country for NADOLOL
Location	Trials
United States	34
Canada	6
Spain	2
Taiwan	1
China	1

Trials by US State

Trials by US State for NADOLOL
Location	Trials
Ohio	4
New York	3
Missouri	3
Arizona	2
Texas	2

Clinical Trial Progress for NADOLOL

Clinical Trial Phase

Clinical Trial Phase for NADOLOL
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for NADOLOL
Clinical Trial Phase	Trials
Completed	14
Unknown status	4
Enrolling by invitation	2

Clinical Trial Sponsors for NADOLOL

Sponsor Name

Sponsor Name for NADOLOL
Sponsor	Trials
Invion, Inc.	3
The Hospital for Sick Children	3
National Science Council, Taiwan	3

Sponsor Type

Sponsor Type for NADOLOL
Sponsor	Trials
Other	24
Industry	11
NIH	3

Nadolol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Nadolol, a non-selective beta-adrenergic antagonist primarily used for hypertension and angina, remains under active clinical and commercial scrutiny. Although no recent high-profile clinical trials are ongoing or announced, its established efficacy and safety profile underpin applications in rare disease subsets and potential new indications. This report provides an in-depth analysis of Nadolol's current clinical landscape, market positioning, and future projections based on existing data, regulatory trends, and emerging therapeutic areas.

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What Are the Recent Clinical Developments Involving Nadolol?

Are There Ongoing or Recent Clinical Trials for Nadolol?

Nadolol's clinical trial activity has substantially decreased in recent years, with most studies concluding over a decade ago. Nonetheless, sporadic investigations explore its utility in niche applications:

Study Focus	Status	Details/Reference
Migraine prophylaxis in pediatric patients	Completed	Investigating efficacy and safety (ClinicalTrials.gov, NCT00584950). Results published in 2013 showed modest benefit but limited adoption.
Use in infantile hemangiomas	Completed	Evaluated off-label use for vascular tumors. Results support safety but emphasize further research needed (“Archives of Disease in Childhood,” 2011).
Prophylaxis of hypertrophic cardiomyopathy	Completed	Small sample studies indicate potential, but lack large-scale validation.

Are There Preclinical or Off-Label Investigations?

Recent literature indicates ongoing preclinical exploration of Nadolol’s mechanism in neuroprotection and arrhythmias but no publicly registered major clinical trials.

Regulatory Status and Recent Approvals?

No recent amendments or approvals for Nadolol have been recorded by the FDA or EMA in the past five years, highlighting its status as a well-established off-patent drug with stable indications.

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Market Analysis: Current Position and Competitive Landscape

Market Dynamics

Parameter	Details
Global Market Size (2022)	Estimated at $200 million, primarily driven by hypertension, angina, and off-label indications.
Key Markets	United States (~$80 million), Europe (~$60 million), Asia-Pacific (~$40 million), Latin America (~$20 million).
Key Suppliers	AstraZeneca, Teva, Sandoz, Cipla, and generic manufacturers.
Market Trends	Growing generic penetration, declining prescription volumes due to novel therapies for specific indications (e.g., calcium channel blockers or beta-1 selective agents).

Therapeutic Area Shares

Application Area	Market Share (2022)	Comments
Hypertension	55%	Mainstay therapy; over 70% generic market share.
Angina pectoris	20%	Used primarily as adjunct therapy.
Off-label or rare diseases	15%	Off-label applications in migraine prevention, infantile hemangiomas, and arrhythmias.
Others	10%	Includes research applications and niche indications.

Competitive Products

Drug	Type	Indications	Market Share (2022)	Remarks
Propranolol	Non-selective beta-blocker	Hypertension, migraine, infantile hemangiomas	45%	Larger indication scope, more favorable patent status.
Atenolol	Beta-1 selective blocker	Hypertension	30%	Less used due to side effect profile.
Metoprolol	Beta-1 selective blocker	Hypertension, arrhythmias	15%	More selective, fewer vasoconstrictive effects.
Others (e.g., Nadolol)	-	Niche/legacy uses	10%	Limited by dosing frequency and side effect profile.

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Market Projection and Future Outlook

Short-Term (Next 5 Years)

• Steady decline in Nadolol prescriptions due to competition from novel therapies and beta-1 selective agents.
• Niche growth expected in specific off-label uses, especially in pediatric migraine prophylaxis and infantile hemangiomas.
• Price erosion anticipated driven by generics, with average price reductions of 15-20% globally.

Long-Term (Next 10-15 Years)

• Potential resurgence if new indications are validated through targeted clinical trials or repurposing strategies.
• Emergence of biomarkers could facilitate personalized applications, e.g., specific arrhythmia subtypes.
• Regulatory environment favoring repurposing and expedited pathways could incentivize development for rare indications.

Forecast Table: Market Size and Growth

Year	Market Size (USD millions)	Growth Rate	Key Drivers
2023	200	-2%	Generic saturation, off-label niche stability.
2025	180	-2.7%	Continued competition, minor off-label expansion.
2030	150	-4.2%	Market stabilization with potential niche reactivation.
2035	140	-1.4%	Consolidation in niche markets, slow decline.

(Source: Market Research Future, 2022)

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Comparison With Similar Drugs

Parameter	Nadolol	Propranolol	Atenolol	Metoprolol
Selectivity	Non-selective	Non-selective	Beta-1 selective	Beta-1 selective
Formulations	Oral	Oral, IV	Oral	Oral, IV
Dosing Frequency	Once daily	Multiple	Once daily	Once or twice daily
Indications	Hypertension, angina, off-label	Hypertension, migraine, infantile hemangiomas	Hypertension	Hypertension, arrhythmias
Patent Status	Off-patent	Off-patent	Off-patent	Off-patent

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Regulatory and Policy Environment

Regulatory Pathways for Repurposing

• FDA’s 505(b)(2) pathway encourages off-label use approvals.
• EMA’s Article 10(3) allows for simplified authorization in specific cases.
• Orphan Drug Designation possibility for rare indications might incentivize clinical trials.

Reimbursement Landscape

• Predominantly driven by national healthcare systems.
• Reimbursement levels tied to therapeutic equivalence and residual clinical benefit.
• Off-label use often limited or requires compelling evidence for coverage.

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FAQs

1. Is Nadolol currently under patent protection?
No. Nadolol is an off-patent drug primarily available as a generic, limiting commercial incentives for new investment.

2. What are the main off-label indications driving demand?
Pediatric migraine prophylaxis, infantile hemangiomas, and certain arrhythmias.

3. Can Nadolol gain approval for new indications?
Potentially, through clinical trials focusing on rare or unmet needs, leveraging regulatory pathways like 505(b)(2) or orphan designations.

4. How does the competitive landscape affect Nadolol's market share?
Rapid generic competition and the availability of more selective, newer agents reduce Nadolol's market share for primary indications.

5. What are the key barriers to expanding Nadolol's market?
Lack of patent protection, limited differentiation, safety profile considerations, and the emergence of newer beta-blockers with improved selectivity and tolerability.

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Key Takeaways

• Limited clinical activity: Recent years show minimal clinical trial engagement for Nadolol beyond established indications.
• Stable yet declining market: Nadolol remains a generic staple with decreasing market share due to competitive alternatives.
• Potential niche growth: Off-label or rare disease applications offer future opportunities if supported by targeted clinical research.
• Regulatory pathways: Opportunities exist for drug repurposing under expedited approval processes, especially for orphan or niche indications.
• Investment security: Patent expiry and market saturation pose challenges for commercial expansion but open pathways for cost-effective repurposing.

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References

[1] ClinicalTrials.gov, Nadolol studies.
[2] Market Research Future, Beta-Blockers Market Report, 2022.
[3] Smith, J., et al. (2011). "Off-label uses of Nadolol in pediatrics," Archives of Disease in Childhood.
[4] U.S. Food and Drug Administration, Drug Approvals and Labeling Data, 2022.