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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR ISOPROTERENOL HYDROCHLORIDE


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505(b)(2) Clinical Trials for Isoproterenol Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00590538 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Cystic Fibrosis Foundation Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
New Combination NCT00590538 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Cystic Fibrosis Foundation Therapeutics Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
New Combination NCT00590538 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Children's Hospital of Philadelphia Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Isoproterenol Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000568 ↗ Lung Health Study (LHS) I and III Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1984-09-01 In the Lung Health Study I, to determine the effects of Special Care, compared to Usual Care, on rate of decline in pulmonary function in a group of cigarette smokers identified as having mild abnormalities in pulmonary function. In the Lung Health Study III, to determine the long-term effects of smoking cessation and continued smoking, on cardiopulmonary morbidity, mortality, and the rate of decline in the one second forced expiratory volume (FEV1) in men and women with early chronic obstructive lung disease who have been followed prospectively for 12 to 15 years.
NCT00226551 ↗ Vascular Response to Isoproterenol and β2 Adrenergic Receptor Polymorphisms Completed Hadassah Medical Organization N/A 1999-08-01 Single nucleotide polymorphisms at codon 46 and 79 of the gene encoding for the ß2 adrenergic receptor (ß2AR) modify its pharmacological properties and may alter the response to ß2AR agonists. The goal of the present study was to evaluate the role played by the Arg16Gly and Gln27Glu polymorphisms on isoproterenol induced relaxation of internal mammary arteries segments ex-vivo. Internal mammary leftover segments were collected from 96 patients undergoing coronary artery bypass graft operation. Four rings that were prepared from each specimen were allowed to reach equilibrium with physiological Krebs solution prior to precontraction with U46619. Using the organ bath technique, cumulative dose response curve of isoproterenol was constructed and mean EC50 calculated for each patient.
NCT00323843 ↗ Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone Unknown status Fredericia Hosptial Phase 2 2006-06-01 Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.
NCT00428428 ↗ Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract Completed Fredericia Hosptial Phase 2/Phase 3 2007-02-01 The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.
NCT00590538 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Cystic Fibrosis Foundation Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
NCT00590538 ↗ Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) Terminated Cystic Fibrosis Foundation Therapeutics Phase 1/Phase 2 2003-02-01 The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Isoproterenol Hydrochloride

Condition Name

Condition Name for Isoproterenol Hydrochloride
Intervention Trials
Atrial Fibrillation 3
Healthy 3
Anorexia Nervosa 2
Arrhythmias, Cardiac 2
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Condition MeSH

Condition MeSH for Isoproterenol Hydrochloride
Intervention Trials
Syndrome 3
Atrial Fibrillation 3
Arrhythmias, Cardiac 2
Tachycardia 2
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Clinical Trial Locations for Isoproterenol Hydrochloride

Trials by Country

Trials by Country for Isoproterenol Hydrochloride
Location Trials
United States 15
Denmark 2
Canada 2
Israel 1
Korea, Republic of 1
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Trials by US State

Trials by US State for Isoproterenol Hydrochloride
Location Trials
Oklahoma 3
Tennessee 3
New York 2
Texas 2
Missouri 1
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Clinical Trial Progress for Isoproterenol Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Isoproterenol Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Isoproterenol Hydrochloride
Clinical Trial Phase Trials
Completed 11
Recruiting 5
Not yet recruiting 4
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Clinical Trial Sponsors for Isoproterenol Hydrochloride

Sponsor Name

Sponsor Name for Isoproterenol Hydrochloride
Sponsor Trials
Vanderbilt University 3
Vanderbilt University Medical Center 3
National Heart, Lung, and Blood Institute (NHLBI) 2
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Sponsor Type

Sponsor Type for Isoproterenol Hydrochloride
Sponsor Trials
Other 51
NIH 3
Industry 1
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Isoproterenol Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Isoproterenol hydrochloride, also known as isoprenaline, is a non-selective beta-adrenergic agonist used in various medical applications, including the treatment of heart block, bronchospasm, and shock. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Isoproterenol hydrochloride is currently involved in several clinical trials across different phases. Here are some notable examples:

  • University of Alberta: A Phase 1 trial is underway, focusing on the drug's efficacy and safety in a specific patient population[1].
  • Renmin Hospital of Wuhan University: A Phase 4 trial is being conducted to evaluate the long-term effects and outcomes of isoproterenol hydrochloride in patients with certain cardiovascular conditions[1].
  • Guangdong Provincial People's Hospital: Another Phase 4 trial is in progress, aiming to assess the drug's performance in managing heart block and other related conditions[1].

These trials are crucial for expanding the understanding of isoproterenol hydrochloride's therapeutic potential and its safety profile.

Pharmacology and Mechanism of Action

Biological Activity

Isoproterenol hydrochloride acts as a non-selective beta-adrenergic agonist, stimulating both β1 and β2 receptors. This activation leads to various physiological effects, including vasorelaxation and bronchodilation. The drug works by activating downstream signaling pathways such as PKA and ERK, and it may also stimulate NO-mediated endothelium-dependent smooth muscle relaxation[4].

Market Analysis

Current Market Size and Segmentation

The global isoproterenol hydrochloride market has shown significant growth in recent years. Here are some key statistics:

  • Global Market Size: The market was valued at USD 1624.5 million in 2024, with North America holding the largest share of over 40% (USD 649.80 million), followed by Europe with over 30% (USD 487.35 million), and Asia-Pacific with around 23% (USD 373.64 million)[5].
  • Segmentation: The market is segmented by type (injection, tablets, others) and application (bronchial asthma, atrioventricular block, others), as well as by geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Market Drivers and Restraints

The market is driven by several factors, including:

  • Rising Demand for Critical Care Services: The increasing need for critical care services, especially in the context of remote health monitoring, is a significant driver[5].
  • Technological Advancements: Improvements in medical technology and the development of new delivery systems are also contributing to market growth.

However, the market also faces some restraints, such as:

  • Regulatory Challenges: Strict regulatory requirements and the need for extensive clinical trials can slow market growth.
  • Competition from Alternative Treatments: The presence of other therapeutic options can reduce the demand for isoproterenol hydrochloride.

Market Projections

Forecasted Growth

The global isoproterenol hydrochloride market is projected to grow at a compound annual growth rate (CAGR) of 5.00% from 2024 to 2031, reaching a value of USD 2285.83 million by 2031[5].

  • Regional Growth: North America is expected to grow at a CAGR of 3.2%, Europe at 3.5%, Asia-Pacific at 7.0%, Latin America at 4.4%, and the Middle East and Africa at 4.7% during the forecast period[5].

Market Opportunities and Challenges

The market presents several opportunities, such as:

  • Expanding into Emerging Markets: There is a significant potential for growth in regions like Asia-Pacific and Latin America.
  • Development of New Applications: Research into new therapeutic uses for isoproterenol hydrochloride could expand its market.

However, challenges include:

  • Compliance with Regulatory Standards: Ensuring compliance with evolving regulatory requirements is crucial.
  • Managing Competition: The market is competitive, and manufacturers need to differentiate their products to maintain market share.

Key Applications and Indications

Heart Block and Cardiac Arrest

Isoproterenol hydrochloride is indicated for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy, as well as for serious episodes of heart block and Adams-Stokes attacks. It is also used in cardiac arrest until more definitive treatments are available[3].

Bronchospasm and Respiratory Conditions

The drug is effective in treating bronchospasm occurring during anesthesia and is used as a bronchodilator in managing conditions like bronchial asthma[3].

Shock and Low Cardiac Output States

Isoproterenol hydrochloride is used as an adjunct in the treatment of hypovolemic and septic shock, low cardiac output states, congestive heart failure, and cardiogenic shock[3].

Conclusion

Isoproterenol hydrochloride remains a vital drug in the management of various cardiovascular and respiratory conditions. The ongoing clinical trials are expected to provide further insights into its efficacy and safety. The market for isoproterenol hydrochloride is projected to grow significantly over the next few years, driven by increasing demand for critical care services and technological advancements.

Key Takeaways

  • Clinical Trials: Ongoing trials are focusing on the drug's efficacy and safety in different patient populations.
  • Market Growth: The global market is expected to grow at a CAGR of 5.00% from 2024 to 2031.
  • Key Applications: The drug is used in treating heart block, cardiac arrest, bronchospasm, and various shock states.
  • Market Segmentation: The market is segmented by type, application, and geographical region.

FAQs

What are the primary indications for isoproterenol hydrochloride?

Isoproterenol hydrochloride is primarily indicated for mild or transient episodes of heart block, serious episodes of heart block and Adams-Stokes attacks, cardiac arrest, bronchospasm during anesthesia, and as an adjunct in treating shock and low cardiac output states[3].

What is the mechanism of action of isoproterenol hydrochloride?

Isoproterenol hydrochloride acts as a non-selective beta-adrenergic agonist, stimulating both β1 and β2 receptors, leading to vasorelaxation and bronchodilation[4].

What is the current market size of isoproterenol hydrochloride?

The global isoproterenol hydrochloride market was valued at USD 1624.5 million in 2024[5].

What is the projected growth rate of the isoproterenol hydrochloride market?

The market is projected to grow at a CAGR of 5.00% from 2024 to 2031, reaching a value of USD 2285.83 million by 2031[5].

Which regions are expected to drive the growth of the isoproterenol hydrochloride market?

North America, Europe, and Asia-Pacific are expected to be significant drivers of market growth, with Asia-Pacific showing the highest CAGR of 7.0% during the forecast period[5].

Sources

  1. Drug Patent Watch: Isoproterenol hydrochloride - Generic Drug Details.
  2. Market Research Intellect: Isoproterenol Hydrochloride Market Size, Scope And Forecast Report.
  3. FDA: Isuprel® Generic Name: isoproterenol hydrochloride.
  4. R&D Systems: Isoproterenol hydrochloride | Non-selective Adrenergic beta ...
  5. Cognitive Market Research: Isoproterenol Market Report 2024 (Global Edition).

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