CLINICAL TRIALS PROFILE FOR NADOLOL

All Clinical Trials for nadolol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for nadolol

Condition Name

Condition Name for nadolol
Intervention	Trials
Heart Failure, Diastolic	2
Infantile Hemangioma	2
Variceal Bleeding	2
Gastrointestinal Hemorrhage	2

Condition MeSH

Condition MeSH for nadolol
Intervention	Trials
Hypertension	5
Hemorrhage	4
Migraine Disorders	3
Liver Cirrhosis	3

Clinical Trial Locations for nadolol

Trials by Country

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Trials by Country for nadolol
Location	Trials
United States	33
Canada	6
Spain	2
Taiwan	1
China	1

Trials by US State

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−

Trials by US State for nadolol
Location	Trials
Ohio	4
New York	3
Missouri	3
Texas	2
North Dakota	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	23
Industry	11
NIH	2

Nadolol: Clinical Trials, Market Analysis, and Projections

Introduction to Nadolol

Nadolol, sold under the brand name Corgard among others, is a non-selective beta-blocker used to treat various cardiovascular conditions, including high blood pressure, heart pain (angina), and atrial fibrillation. It is also utilized to prevent migraine headaches and complications of cirrhosis.

Clinical Trials Update

Nadolol vs Propranolol in Infantile Hemangiomas

A significant clinical trial published in 2021 compared the efficacy and safety of nadolol versus propranolol in infants with infantile hemangiomas (IH). This randomized clinical trial involved 71 patients, with 36 treated with propranolol and 35 with nadolol. The results showed that nadolol was noninferior to propranolol in terms of size and color reduction of the hemangiomas. In fact, nadolol demonstrated a larger change in size and color compared to propranolol, indicating it may be an efficacious and safe alternative, especially in cases of propranolol unresponsiveness or adverse events[1].

Pharmacokinetics in Special Populations

A comprehensive physiologically based pharmacokinetic (PBPK) model of nadolol has been developed to simulate its pharmacokinetics in healthy adults, patients with renal impairment, and pediatric populations. This model highlights the importance of adjusting nadolol dosages based on renal function, as the half-life of nadolol can increase significantly in patients with moderate to severe kidney failure[3].

Nadolol in Neurodegenerative Diseases

CuraSen Therapeutics has been conducting clinical trials using nadolol in combination with other drugs to treat neurodegenerative diseases. A Phase 1 study involving 79 healthy volunteers and patients with mild cognitive impairment (MCI) showed that the combination of CST-2032 and nadolol was safe and well-tolerated, increasing cerebral blood flow and improving performance in cognitive tasks. This combination is set to be tested further in a Phase 2 study for Parkinson’s disease patients[4].

Market Analysis

Current Market Size and Forecast

The global nadolol market was valued at US$ 236 million in 2023. However, it is forecasted to decline to US$ 183 million by 2030, with a compound annual growth rate (CAGR) of -3.6% during the period from 2024 to 2030. This decline is part of a broader trend in the pharmaceutical market, influenced by various factors including changes in healthcare policies and the impact of the COVID-19 pandemic[2][5].

Market Segmentation

The nadolol market is segmented by type (20mg, 40mg, 80mg), application (high blood pressure, heart pain, atrial fibrillation), and region (North America, Europe, Asia Pacific, South America, Middle East and Africa). Key players in the market include Zydus Pharmaceuticals, Vgyaan, Sandoz, Novast Labs, Mylan, Lupin, Invagen Pharmaceuticals, Heritage Pharmaceuticals, Beximco Pharmaceuticals, Amneal Pharmaceuticals, and Worldmeds[2][5].

Competitive Landscape

The competitive landscape of the nadolol market is characterized by a mix of established pharmaceutical companies and newer entrants. The report provides detailed profiles of key competitors, their market ranks, and their respective market shares. It also discusses technological trends and new product developments that are shaping the market[5].

Projections and Future Outlook

Regional Market Trends

The market trends vary significantly by region. North America, Europe, and Asia Pacific are expected to remain key markets for nadolol, with each region having its own set of challenges and opportunities. For instance, the North American market is expected to see a decline due to increased competition from generic drugs, while the Asia Pacific region may offer growth opportunities due to its large and growing population[5].

Impact of Clinical Trials on Market

The outcomes of clinical trials, such as those comparing nadolol to propranolol in infantile hemangiomas, can significantly impact the market. Positive results can lead to increased adoption and market share, while adverse outcomes can result in decreased usage. The ongoing trials in neurodegenerative diseases also hold promise for expanding nadolol’s therapeutic applications, potentially stabilizing or even growing the market[1][4].

Challenges and Opportunities

One of the significant challenges facing the nadolol market is the decline in its use due to the availability of newer and more targeted therapies. However, the drug’s safety profile and efficacy in specific conditions, such as infantile hemangiomas, present opportunities for continued use. Additionally, the potential expansion into neurodegenerative diseases could open new avenues for growth[4].

Key Takeaways

• Clinical Efficacy: Nadolol has been shown to be noninferior to propranolol in treating infantile hemangiomas and may offer benefits in neurodegenerative diseases.
• Market Trends: The global nadolol market is forecasted to decline from US$ 236 million in 2023 to US$ 183 million by 2030, with a CAGR of -3.6%.
• Market Segmentation: The market is segmented by type, application, and region, with key players including several major pharmaceutical companies.
• Future Outlook: The market will be influenced by clinical trial outcomes, regional trends, and the potential expansion into new therapeutic areas.

FAQs

What is nadolol used for?

Nadolol is used to treat high blood pressure, heart pain (angina), atrial fibrillation, and to prevent migraine headaches and complications of cirrhosis.

How does nadolol compare to propranolol in treating infantile hemangiomas?

Nadolol has been shown to be noninferior to propranolol in treating infantile hemangiomas, with some studies indicating it may be more effective in reducing the size and color of the hemangiomas.

What is the forecasted market size of nadolol by 2030?

The global nadolol market is forecasted to be US$ 183 million by 2030, with a CAGR of -3.6% from 2024 to 2030.

Who are the key players in the nadolol market?

Key players include Zydus Pharmaceuticals, Vgyaan, Sandoz, Novast Labs, Mylan, Lupin, Invagen Pharmaceuticals, Heritage Pharmaceuticals, Beximco Pharmaceuticals, Amneal Pharmaceuticals, and Worldmeds.

Is nadolol being explored for use in neurodegenerative diseases?

Yes, nadolol is being explored in combination with other drugs for the treatment of neurodegenerative diseases such as Parkinson’s disease and mild cognitive impairment.

Sources

1. JAMA Pediatrics: "Noninferiority and Safety of Nadolol vs Propranolol in Infants With Infantile Hemangiomas: A Randomized Clinical Trial"[1].
2. Valuates Reports: "Nadolol - Market, Report Size, Worth, Revenue, Growth, Industry Trends"[2].
3. MDPI Pharmaceuticals: "A Comprehensive Physiologically Based Pharmacokinetic Model of Nadolol in Adults with Renal Disease and Pediatrics with Supraventricular Tachycardia"[3].
4. CuraSen Therapeutics: "CuraSen Therapeutics to Present Phase 2 Data Showing Rapid Onset Cognition and Mood Benefit with CST-103/CST-107 in Parkinson’s Disease"[4].
5. QYResearch: "Global Nadolol Market Research Report 2024"[5].