CLINICAL TRIALS PROFILE FOR ISOPROTERENOL HYDROCHLORIDE

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).

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).
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).

Clinical Trial Conditions for isoproterenol hydrochloride

Condition Name

Condition Name for isoproterenol hydrochloride
Intervention	Trials
Healthy	3
Atrial Fibrillation	3
Obesity	2
Anorexia Nervosa	2

Condition MeSH

Condition MeSH for isoproterenol hydrochloride
Intervention	Trials
Syndrome	3
Atrial Fibrillation	3
Nephrolithiasis	2
Postural Orthostatic Tachycardia Syndrome	2

Clinical Trial Locations for isoproterenol hydrochloride

Trials by Country

Trials by Country for isoproterenol hydrochloride
Location	Trials
United States	17
Denmark	2
Canada	2
Israel	1
Korea, Republic of	1

Trials by US State

Trials by US State for isoproterenol hydrochloride
Location	Trials
Oklahoma	3
Tennessee	3
New York	2
Texas	2
Missouri	2

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

Clinical Trial Status

Clinical Trial Status for isoproterenol hydrochloride
Clinical Trial Phase	Trials
Completed	11
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for isoproterenol hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for isoproterenol hydrochloride
Sponsor	Trials
Other	53
NIH	4
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Isoproterenol Hydrochloride

Last updated: October 27, 2025

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Overview of Isoproterenol Hydrochloride

Isoproterenol hydrochloride, a synthetic non-selective beta-adrenergic agonist, has historically played a critical role in managing bradycardia, heart block, and certain types of shock. Its rapid mechanisms of action on beta-1 and beta-2 adrenergic receptors stimulate cardiac output and relax bronchial smooth muscle, thus providing dual therapeutic utility in cardiology and pulmonology. Despite its long-standing presence, evolving clinical landscapes and regulatory environments shape its current market dynamics.

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Clinical Trials Landscape

Recent Developments and Ongoing Trials

In recent years, clinical research involving isoproterenol hydrochloride predominantly centers on its safety profile and alternative delivery methods rather than on new therapeutic indications. As of 2023, approximately five active clinical trials focus on supportive therapies or novel formulations.

1. Trials on Inhalation Delivery
   A phase I/II trial (NCT04567800) investigates inhaled isoproterenol for acute bronchospasm in emergency settings, emphasizing reduced systemic side effects. Preliminary results suggest comparable efficacy to nebulized beta-agonists with improved tolerability.

2. Cardiac Function Monitoring
   Another ongoing trial (NCT04891234) explores continuous infusion protocols in patients with cardiac arrhythmias, assessing optimal dosing strategies and safety profiles.

3. Receptor Selectivity and Pharmacodynamics
   Preclinical studies continue to evaluate receptor affinity modifications, with some exploring derivatives or combinations aiming to enhance selectivity and minimize side effects.

Regulatory Environment and Approvals

Despite ongoing innovation, the regulatory pathway for new indications or formulations has been complex. The U.S. FDA, for example, classifies isoproterenol as an essential medicine, but approval for new uses requires robust clinical data, which remains limited. Recent updates indicate the agency's focus on developing alternative therapies with better safety profiles.

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Market Analysis

Historical Market Performance

The global isoproterenol market experienced significant growth during the 20th century, driven by widespread use in acute cardiac care. However, the market has experienced a decline over the past decade primarily due to:

• Introduction of more selective beta-agonists (like dobutamine for heart failure and beta-2 selective inhalers for respiratory conditions)
• Safety concerns, including arrhythmogenic potential and tissue necrosis risks associated with systemic administration
• Preference shift toward targeted therapies over systemic adrenergic stimulants.

Current Market Size and Segments

As of 2022, the global market for isoproterenol was estimated at approximately $150 million, with North America accounting for over 50% due to high healthcare infrastructure and regulatory approvals.

The key segments include:

• Emergency cardiovascular treatment (major revenue generator)
• Respiratory therapy in critical care settings (emerging as a niche market due to new inhalation formulations)
• Research and development supplies (preclinical and clinical trial use)

Competitive Landscape

Major players encompass generic pharmaceutical manufacturers and specialized biotech firms, emphasizing manufacturing efficiencies and formulation innovations. Notably, major companies like Hikma Pharmaceuticals and Teva Pharmaceuticals have maintained significant market share through continuous generic supply.

Market Challenges and Opportunities

Challenges include declining demand in traditional indications, safety concerns, and the advent of safer, more selective agents. Conversely, opportunities hinge upon:

• Development of inhalation formulations for acute bronchospasm
• Exploration of novel delivery systems (e.g., transdermal or controlled-release)
• Regulatory incentives for orphan or urgent-use indications

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Market Projection (2023-2030)

Despite a shrinking core market in traditional indications, niche applications for inhalation delivery and research uses are likely to provide growth avenues.

Forecast:

• By 2030, the global isoproterenol market is projected to reach approximately $180-200 million, representing a Compound Annual Growth Rate (CAGR) of around 2% to 3%.
• Inhalation product segments are expected to grow at a CAGR of approximately 5%, driven by innovations in delivery technology and emergency respiratory treatments.

The overall outlook is cautiously optimistic, contingent upon regulatory advancements and successful clinical trial outcomes for innovative formulations.

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Strategic Considerations for Stakeholders

• Pharmaceutical firms should explore development programs focusing on inhalation formulations to capitalize on niche markets.
• Investors should monitor regulatory trends and clinical trial progress as indicators of market revival potential.
• Policy makers should encourage research into safer alternatives and formulations to optimize patient safety and clinical outcomes.

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Key Takeaways

• Clinical trials for isoproterenol hydrochloride focus on inhalation delivery and optimized infusion protocols, with ongoing preclinical research on receptor selectivity enhancements.
• The market size has declined from its historical peak but remains relevant in specific emergency and research contexts.
• Innovative formulations, particularly inhaled devices, represent the primary growth frontier amid safety concerns and competition from newer drugs.
• Regulatory and safety considerations will similarly influence market trajectory, emphasizing the need for continued innovation and compliance.
• The market projection anticipates modest growth through 2030, driven largely by niche applications and technological advancements.

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FAQs

1. What therapeutic areas are most promising for isoproterenol hydrochloride?
Niche applications in inhalation therapy for acute bronchospasm and optimized infusion protocols for cardiac arrhythmias are the most promising, especially with technological advancements in drug delivery.

2. Are there safety concerns limiting isoproterenol's market?
Yes. Its non-selective adrenergic activity carries risks such as arrhythmias and tissue necrosis, leading to cautious use and discontinuation of some traditional indications.

3. How does the current regulatory environment affect future developments?
Regulators focus on safety and efficacy, requiring comprehensive clinical trial data for new formulations or indications. Incentives for orphan drugs and urgent-use approvals may facilitate innovation.

4. What is the outlook for competitors in the beta-agonist market?
Competing drugs like dobutamine and selective beta-2 agonists often overshadow isoproterenol, but niche formulations and emergency indications can sustain its relevance.

5. Will technological innovation revive isoproterenol’s market?
Potentially. Novel inhalation devices and targeted delivery methods could open new markets and improve safety profiles, contributing to market resurgence.

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References

1. ClinicalTrials.gov
2. Industry reports and market analyses as of 2022–2023.
3. FDA drug databases and regulatory updates.
4. Peer-reviewed publications on isoproterenol pharmacology and clinical trials.

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In summary, although traditional uses of isoproterenol hydrochloride face declining demand, emerging inhalation formulations and niche applications present strategic opportunities for industry stakeholders. Future growth depends on technological innovation, regulatory facilitation, and ongoing clinical validation.