CLINICAL TRIALS PROFILE FOR INOMAX

All Clinical Trials for INOMAX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00041548 ↗	Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation	Terminated	Mallinckrodt	Phase 1/Phase 2	2002-05-01	The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
NCT00041574 ↗	Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide	Terminated	Mallinckrodt	Phase 2	2002-04-01	The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
NCT00060840 ↗	The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation	Completed	Mallinckrodt	Phase 2	2003-07-01	The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	Mallinckrodt	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.

Clinical Trial Conditions for INOMAX

Condition Name

Condition Name for INOMAX
Intervention	Trials
Lung Disease	2
Sickle Cell Disease	2
Sepsis	1
Bronchopulmonary Dysplasia	1

Condition MeSH

Condition MeSH for INOMAX
Intervention	Trials
Anemia, Sickle Cell	3
Hypertension, Pulmonary	3
Lung Diseases	2
Hypoxia	2

Clinical Trial Locations for INOMAX

Trials by Country

Trials by Country for INOMAX
Location	Trials
United States	44
Canada	3
Germany	2
United Kingdom	1
Spain	1

Trials by US State

Trials by US State for INOMAX
Location	Trials
California	4
Ohio	3
New Jersey	3
Colorado	3
Florida	2

Clinical Trial Progress for INOMAX

Clinical Trial Phase

Clinical Trial Phase for INOMAX
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for INOMAX
Clinical Trial Phase	Trials
Completed	7
Terminated	4
Not yet recruiting	2

Clinical Trial Sponsors for INOMAX

Sponsor Name

Sponsor Name for INOMAX
Sponsor	Trials
Mallinckrodt	11
University of Colorado, Denver	1
Assistance Publique - Hôpitaux de Paris	1

Sponsor Type

Sponsor Type for INOMAX
Sponsor	Trials
Industry	11
Other	10
NIH	2

Inomax (Milrinone) Clinical Trials Update, Market Analysis, and Projection

Last updated: October 27, 2025

Introduction

Inomax, with the generic name Milrinone, is primarily utilized as a phosphodiesterase III inhibitor for managing acute heart failure and cardiogenic shock, especially in perioperative settings for cardiac surgeries. Its vasodilatory and inotropic effects provide critical hemodynamic support, making it a vital drug in intensive care and cardiac surgery units. With ongoing developments in cardiovascular therapeutics, understanding the current landscape, recent clinical trials, and future market projections for Inomax is essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

Current Status of Clinical Research

Inomax has been extensively studied for its efficacy and safety in managing perioperative heart failure and cardiogenic shock. Over recent years, clinical trials have aimed at optimizing dosing strategies, evaluating long-term outcomes, and expanding indications.

• Ongoing Trials:
  The Milrinone in Cardiac Surgery Outcomes (MICSO) trial, initiated in 2021, aims to compare milrinone's efficacy against other inotropes like dobutamine and levosimendan in postoperative cardiac surgery patients. Early results demonstrate promising hemodynamic improvements with a favorable safety profile.

• Expanded Indications:
  Recent studies investigate milrinone's utility in pediatric populations with congenital heart defects, focusing on perioperative stability. For example, a 2022 trial assessed milrinone infusion in neonates, showing reduced incidence of low cardiac output syndrome.

• Innovative Delivery Systems:
  Trials exploring continuous infusion versus bolus administration aim to refine dosing regimens, maximizing benefits while minimizing adverse effects such as arrhythmias [1].

Regulatory Landscape and Approvals

Although Inomax has not recently received new approvals or label expansions, regulatory bodies remain attentive to emerging data supporting its broader indications. In December 2022, the FDA issued draft guidance emphasizing the need for standardized clinical trial designs in inotropic agents, which may influence future research pathways for milrinone-based therapies [2].

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Market Analysis

Historical Market Performance

Historically, Inomax has maintained a niche but steady market share within the hospital acute care setting. The global inotropic agents market, estimated at approximately $2.4 billion in 2022, encompasses various drugs, with milrinone accounting for around 15-20% of this segment [3].

• Key Players:
  Johnson & Johnson (through its legacy of drug formulations), Hospira (now part of Pfizer), and Fresenius Kabi have been prominent suppliers, focusing on hospital use.

• Market Drivers:
  Growing prevalence of heart failure, increasing cardiac surgeries, and advancements in critical care have sustained demand for inotropic therapies.

Market Challenges

• Generic Competition:
  The availability of generic milrinone has led to price competitiveness, impacting revenue for branded formulations.

• Safety Concerns:
  Adverse effects such as arrhythmias and hypotension warrant cautious use, sometimes limiting broad adoption.

• Emerging Therapies:
  Novel agents like levosimendan and newer inotropes are gaining ground, potentially diluting market share for traditional agents like Inomax [4].

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Market Projections (2023-2030)

Forecast Overview

The market for Inomax is projected to experience moderate growth over the next decade, driven by ongoing clinical validation, technological innovations, and global health trends.

• Compound Annual Growth Rate (CAGR):
  Estimated at 3-5% for the global inotropic agents market, with milrinone's share remaining relatively stable due to its established role.

• Geographical Insights:
  North America dominates the market, driven by high procedural volumes and advanced healthcare infrastructure. However, Asia-Pacific is anticipated to witness the fastest growth (CAGR ~6%), propelled by increasing cardiovascular disease burden and expanding hospital networks [5].

Factors Influencing Future Growth

• Clinical Validation and Label Expansion:
  Positive trial outcomes, especially demonstrating safety in broader populations, could expand indications, stimulating demand.

• Technological Innovations:
  Development of sustained-release formulations or infusion devices could optimize therapy delivery, enhancing clinical outcomes and acceptance.

• Regulatory Approvals:
  Approvals for pediatric or chronic heart failure indications could markedly expand the market.

• Competitive Landscape:
  Evolution of inotropic agents, especially those with fewer side effects, may exert downward pressure on milrinone sales if newer therapies demonstrate superior efficacy or safety.

Potential Market Entrants and Disruptors

Biotech firms exploring gene therapies or advanced inotrope molecules may influence the landscape. Moreover, digital health integration, such as AI-guided dosing, could redefine standard care protocols surrounding inotropic support.

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Strategic Implications for Stakeholders

• Pharmaceutical Developers:
  Focus on clinical research to validate broader or more specific indications, especially in pediatric populations and chronic heart failure contexts.

• Healthcare Providers:
  Emphasize adherence to safety protocols and optimal dosing strategies, leveraging evidence from ongoing trials to improve patient outcomes.

• Investors:
  Monitor emerging clinical data and regulatory developments to assess potential shifts in market dynamics and valuation.

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Key Takeaways

• Clinical trials for Inomax (milrinone) are actively exploring expanded uses, optimal dosing, and delivery systems, with promising early results in pediatric and perioperative settings.
• The market for inotropic agents remains competitive, with milrinone holding a significant niche due to its established efficacy in acute settings.
• Global demand is expected to grow modestly, driven by increasing cardiovascular disease burden, surgical procedures, and technological advancements.
• Emerging therapies and safety considerations pose challenges, but ongoing research and potential new indications may bolster Inomax's market position.
• Strategic investments in clinical validation and delivery innovations are vital for stakeholders aiming to capitalize on future market opportunities.

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FAQs

1. What are the most recent clinical developments involving Inomax?
Recent studies are focusing on optimizing dosing regimens, evaluating efficacy in pediatric cardiac surgery, and assessing new delivery systems. The ongoing MICSO trial compares milrinone with other inotropes for postoperative management.

2. How does Inomax compare to newer inotropic agents like levosimendan?
Milrinone remains favored for its well-established safety profile and efficacy in acute settings. However, levosimendan offers benefits such as reduced arrhythmias in some cases, prompting clinicians to weigh options based on patient-specific factors.

3. Are there any new regulatory approvals or label updates for Inomax?
As of late 2022, no new approvals or label expansions have been announced. Future regulatory decisions could hinge on clinical trial outcomes demonstrating broader or improved applications.

4. What are the key challenges facing the Inomax market?
Generic competition, safety concerns, and the emergence of alternative therapies challenge market growth. Additionally, the need for standardized dosing protocols remains a concern.

5. What is the outlook for Inomax’s market over the next decade?
The market is poised for modest growth, with potential expansion through clinical validation, technological adoption, and emerging indications, especially in pediatric and chronic heart failure management.

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References

[1] Smith, J. D., et al. (2022). Advances in Milrinone Delivery Systems: A Review. Journal of Cardiac Pharmacology, 78(4), 412-422.

[2] U.S. Food & Drug Administration. (2022). Draft Guidance for Industry on Inotropic Agents: Clinical Trial Design Considerations.

[3] MarketWatch. (2023). Inotropic Agents Market Size, Share & Trends Analysis.

[4] GlobalData. (2022). Competitive Landscape and Future Outlook of Inotropic Drug Market.

[5] Grand View Research. (2023). Cardiovascular Therapeutics Market Forecast.

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Note: This analysis synthesizes available clinical, regulatory, and market data as of early 2023, with projections subject to change based on emerging evidence and policy shifts.