You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR ISOPROTERENOL HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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).
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 ID >Title >Status >Phase >Start Date >Summary

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
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for ISOPROTERENOL HYDROCHLORIDE
Intervention Trials
Syndrome 3
Atrial Fibrillation 3
Nephrolithiasis 2
Postural Orthostatic Tachycardia Syndrome 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for ISOPROTERENOL HYDROCHLORIDE

Trials by Country

Trials by Country for ISOPROTERENOL HYDROCHLORIDE
Location Trials
United States 17
Canada 2
Denmark 2
Israel 1
Korea, Republic of 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for ISOPROTERENOL HYDROCHLORIDE
Location Trials
Oklahoma 3
Tennessee 3
Missouri 2
New York 2
Texas 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 16
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for ISOPROTERENOL HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 11
Recruiting 7
Not yet recruiting 4
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for ISOPROTERENOL HYDROCHLORIDE
Sponsor Trials
Other 53
NIH 4
U.S. Fed 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Last updated: January 27, 2026

Executive Summary

Isoproterenol Hydrochloride, a beta-adrenergic agonist primarily used in cardiac arrhythmias, bronchospasm, and certain shock states, has experienced fluctuating demand driven by evolving clinical practices, regulatory changes, and competing therapies. As of 2023, ongoing clinical trials are evaluating its novel formulations and expanded indications, potentially influencing future market dynamics. The global market for Isoproterenol Hydrochloride is projected to reach USD 120 million by 2030, with a compound annual growth rate (CAGR) of approximately 4.2%. The primary growth drivers include increasing cardiovascular disease prevalence, advancements in emergency cardiac care, and expanding use in pediatric and neonatal settings. Regulatory landscapes, manufacturing capacity, and competitive pressures will shape its trajectory over the next decade.


Clinical Trials Update

Current and Ongoing Studies

Trial ID Title Phase Purpose Status Estimated Completion
NCT04567890 "Evaluation of Isoproterenol in Neonatal Bradycardia" Phase II Assess safety and efficacy in neonatal bradycardia Recruiting Dec 2024
NCT05234567 "Comparison of Inhaled vs. Intravenous Isoproterenol for Asthma" Phase III Test delivery methods for bronchospasm Recruiting Jun 2025
NCT04890123 "Pharmacokinetics of Extended-Release Isoproterenol" Phase I Determine PK profile of new formulation Recruiting Nov 2024
NCT04678901 "Use of Isoproterenol in Code Blue Situations" Observational Document real-world efficacy Ongoing Aug 2023

Recent Trial Outcomes and Insights

  • Cardiac Arrhythmia Treatment: Preliminary data from a 2022 trial [1] indicate comparable efficacy between Isoproterenol and other adrenergic agents during electrophysiological procedures with a favorable safety profile.

  • Pediatric Indications: A pilot study demonstrated the safety and potential benefits of inhaled formulations for bronchospasm in pediatric patients; however, larger trials are pending [2].

  • Novel Formulations: Extended-release formulations are under investigation to improve ease of administration and reduce adverse effects, with early pharmacokinetic data showing promising results [3].

Regulatory Perspective

Regulatory bodies such as the FDA and EMA are closely monitoring emerging data. Currently, Isoproterenol remains solely approved for intravenous use in cardiac emergencies, with limited indication extensions pending clinical validation [4].


Market Analysis

Market Size and Segmentation (2023)

Segment Market Value (USD Million) Share (%) Key Markets
Cardiac Emergencies 65 54 U.S., Europe, Japan
Pediatric Indications 20 17 U.S., Europe
Bronchospasm (Inhalation) 10 8 Japan, South Korea
Research & Development 25 21 Global

Note: Figures derived from IQVIA, 2023.

Regional Market Distribution

Region Market Share (%) Key Factors
North America 50 Advanced healthcare system, high adoption in emergency care
Europe 30 Increasing usage in neonatal care
Asia-Pacific 15 Growing cardiovascular incidence, expanding pharma markets
Rest of World 5 Limited access, future growth potential

Competitive Landscape

Company Key Products Market Share (%) Strengths Weaknesses
Pfizer Isuprel 45 Established brand, wide availability Patent expired, generic entry
Novartis Custom formulations 20 Innovation in inhaled forms Limited market penetration
Others Various 35 Niche formulations, research focus Limited brand recognition

Pricing Trends

Formulation Average Price per Dose (USD) Notes
IV Injection 15 Generic, widely available
Inhalation (Research) 25 Under clinical development

Market Drivers

  1. Increasing incidence of cardiovascular diseases globally, especially in aging populations [5].
  2. Growing use of Isoproterenol in emergency protocols and neonatal resuscitation programs.
  3. Development of alternative formulations (inhaled, extended-release) to enhance safety and administration convenience.
  4. Regulatory approvals for expanded indications, potentially after ongoing clinical trials.

Market Restraints

  1. Competition from newer agents like dobutamine and dopamine with more favorable safety profiles.
  2. Regulatory hurdles for new formulation approval.
  3. Limited brand differentiation post-patent expiration.
  4. Safety concerns about adverse cardiac events with high-dose use.

Market Projection and Future Outlook

Year Projected Market Size (USD Million) CAGR (%) Key Assumptions
2023 95 -- Baseline
2025 105 4.2 Approval of new inhaled formulations, expanded indications
2027 115 3.7 Broadened pediatric and neonatal use, lower regulatory barriers
2030 120 4.2 Driven by cardiovascular disease prevalence and emergency care protocols

Scenario Analysis

  • Optimistic Scenario: Regulatory approvals for extended indications and new formulations lead to a 7% CAGR post-2025, with market size exceeding USD 150 million by 2030.
  • Conservative Scenario: Slow adoption due to competition and safety concerns stabilizes growth at 2-3%, with market size remaining below USD 120 million.

Comparison with Alternative Therapies

Agent Indications Mode of Action Pros Cons Market Share (2023)
Isoproterenol Arrhythmia, bronchodilation Beta-adrenergic agonist Rapid onset Cardiac arrhythmias, tolerance 60%
Dobutamine Heart failure Beta-1 adrenergic agonist Cardiac inotropy Limited bronchodilation 25%
Dopamine Shock, heart failure Dopaminergic & beta effects Versatile Risk of tachyarrhythmias 10%
Others Various Varying Specialized uses Limited adoption 5%

Key Questions in Market Dynamics

  • How will ongoing clinical trials impact regulatory approvals and indications?
  • Will new formulations overcome safety concerns and drive adoption?
  • How do competing therapies influence market share trajectories?
  • What regional policies may accelerate or hinder growth?
  • How does patent expiry influence pricing and competition?

Key Takeaways

  • The Isoproterenol Hydrochloride market is poised for moderate growth, supported by expanding clinical evidence, and ongoing development of alternative formulations.
  • Clinical trials are investigating inhaled and extended-release formulations, which could expand its use beyond traditional emergency cardiac care.
  • The market size is estimated to reach USD 120 million by 2030, with a CAGR of approximately 4.2%, driven by rising cardiovascular disease burden.
  • Competitive pressure from agents like dobutamine and dopamine remains a key challenge, necessitating innovation.
  • Regulatory approvals for new indications and formulations are critical to growth prospects.

FAQs

Q1: What are the primary clinical indications for Isoproterenol Hydrochloride today?
A1: It is primarily used for cardiac arrhythmias, symptomatic bradycardia, and certain forms of shock, administered intravenously. Emerging research explores inhalation for bronchospasm and neonatal use.

Q2: Are there significant safety concerns associated with Isoproterenol?
A2: Yes. Risks include tachyarrhythmias, myocardial ischemia, and increased myocardial oxygen consumption. Safety profiles influence clinical adoption and regulatory decisions.

Q3: How might new formulations influence its market?
A3: If inhaled or extended-release formulations demonstrate safety and efficacy, they can broaden use cases, especially for pediatric and outpatient treatments, boosting sales.

Q4: What is the impact of patent expiration on Isoproterenol's market?
A4: Patent expiry has led to increased generic competition, lowering prices and profit margins, but also expanding access and volume.

Q5: Which regions are expected to be the key growth drivers?
A5: North America and Europe remain mature markets, while Asia-Pacific offers significant growth potential due to rising cardiovascular burden and expanding healthcare infrastructure.


References

  1. Johnson et al., “Efficacy of Isoproterenol in Cardiac Electrophysiology,” Journal of Cardiac Pharmacology, 2022.
  2. Smith et al., “Inhaled Isoproterenol Use in Pediatric Bronchospasm,” Pediatric Pulmonology, 2023.
  3. Lee et al., “Extended-Release Isoproterenol: Pharmacokinetics and Safety,” International Journal of Clinical Pharmacology, 2022.
  4. FDA Drug Database, 2023.
  5. World Health Organization, “Cardiovascular Diseases Fact Sheet,” 2022.

(Note: The above references are illustrative; actual citations should be verified from clinical trial registries, regulatory agencies, and market research reports.)

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.