CLINICAL TRIALS PROFILE FOR EPOPROSTENOL SODIUM

All Clinical Trials for EPOPROSTENOL SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01105091 ↗	Epoprostenol for Injection in Pulmonary Arterial Hypertension	Completed	Actelion	Phase 4	2010-03-01	This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from 8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1 respectively) for 28 days of treatment.
NCT00643604 ↗	Rapid Switch From Flolan to Remodulin in the Outpatient Clinic	Terminated	United Therapeutics	Phase 4	2008-03-01	The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
NCT00439946 ↗	Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH	Terminated	United Therapeutics	Phase 4	2007-02-01	The purpose of this 8-week study is to compare the effects of switching from intravenous Flolan to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study, Remodulin will be given using a smaller and lighter medication pump called the Crono Five infusion pump. This study will also assess the effect that changing to Remodulin will have on treatment satisfaction and patient quality of life.
NCT00373360 ↗	Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin	Completed	United Therapeutics	Phase 4	2006-09-01	The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
NCT01014156 ↗	Epoprostenol in Pulmonary Embolism	Completed	Free University Medical Center	Phase 4	2004-01-01	You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants. The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized. The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized

Clinical Trial Conditions for EPOPROSTENOL SODIUM

Condition Name

Condition Name for EPOPROSTENOL SODIUM
Intervention	Trials
Pulmonary Arterial Hypertension	3
Hypertension, Pulmonary	2
Acute Pulmonary Embolism	1
Pulmonary Hypertension	1

Condition MeSH

Condition MeSH for EPOPROSTENOL SODIUM
Intervention	Trials
Hypertension	6
Pulmonary Arterial Hypertension	5
Familial Primary Pulmonary Hypertension	4
Hypertension, Pulmonary	3

Clinical Trial Locations for EPOPROSTENOL SODIUM

Trials by Country

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Trials by Country for EPOPROSTENOL SODIUM
Location	Trials
United States	23
Netherlands	2
Canada	1

Trials by US State

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−

Trials by US State for EPOPROSTENOL SODIUM
Location	Trials
North Carolina	3
California	3
Texas	3
Colorado	2
Ohio	2

Clinical Trial Progress for EPOPROSTENOL SODIUM

Clinical Trial Phase

Clinical Trial Phase for EPOPROSTENOL SODIUM
Clinical Trial Phase	Trials
Phase 4	7

Clinical Trial Status

Clinical Trial Status for EPOPROSTENOL SODIUM
Clinical Trial Phase	Trials
Completed	5
Terminated	2

Clinical Trial Sponsors for EPOPROSTENOL SODIUM

Sponsor Name

Sponsor Name for EPOPROSTENOL SODIUM
Sponsor	Trials
United Therapeutics	3
Actelion	2
Free University Medical Center	1

Sponsor Type

Sponsor Type for EPOPROSTENOL SODIUM
Sponsor	Trials
Industry	6
Other	1

Epoprostenol Sodium: Clinical Trials, Market Analysis, and Projections

Introduction to Epoprostenol Sodium

Epoprostenol sodium, a prostacyclin analogue, is a crucial medication in the treatment of pulmonary arterial hypertension (PAH). It works by dilating pulmonary blood vessels and reducing the pressure in the pulmonary arteries, thereby improving exercise capacity and quality of life for patients.

Clinical Trials and Efficacy

Epoprostenol in PAH Treatment

Clinical trials have consistently shown the efficacy of epoprostenol in treating PAH. In two prospective, open-label, randomized trials, patients with idiopathic pulmonary arterial hypertension (IPAH) or heritable PAH (HPAH) were treated with epoprostenol plus conventional therapy or conventional therapy alone. The results indicated a statistically significant improvement in exercise capacity, as measured by the 6-Minute Walk Test, with improvements apparent as early as the first week of therapy[4].

Hemodynamic Improvements

Epoprostenol has been shown to significantly improve hemodynamic parameters. Patients receiving epoprostenol plus conventional therapy experienced an increase in cardiac index by 15% and stroke volume by 14%, along with a decrease in mean pulmonary arterial pressure by 8% and pulmonary vascular resistance by 25%[4].

Survival and Quality of Life

The trials also demonstrated improved survival rates and quality of life. None of the 41 patients receiving epoprostenol died during the 12-week study period, compared to 20% mortality in the conventional therapy group. Quality of life, as measured by the Chronic Heart Failure Questionnaire, the Nottingham Health Profile, and the Dyspnea-Fatigue Rating, also showed significant improvements[4].

Comparison with Other Treatments

Epoprostenol has been compared to other treatments such as iloprost and bosentan. For instance, continuous intravenous administration of iloprost appears to be as effective as epoprostenol in patients with PAH, although each has its own side effect profile and administration challenges[1].

Market Analysis

Global Market Size and Forecast

The global epoprostenol sodium market is projected to grow significantly over the forecast period. The market size is estimated to increase from 2025 to 2031, driven by factors such as the increasing prevalence and incidence of PAH, unmet needs, orphan drug status, and the faster approval pathway for premium-priced drugs[3].

Market Segmentation

The market is segmented based on application (injection and other forms) and product purity (above 98% and below 98%). The injection segment is expected to account for the largest share due to its efficacy and the critical need for continuous administration in PAH patients[5].

Regional Analysis

The global epoprostenol sodium market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America and Europe are expected to dominate the market due to higher healthcare spending and greater awareness of PAH treatments[5].

Market Drivers and Restraints

Key drivers of the market include the increasing prevalence of PAH, advancements in treatment options, and the premium pricing of these drugs. However, restraints such as high production costs, the need for continuous infusion, and potential side effects (e.g., infusion-site pain) may limit market growth[3].

Market Projections

Growth Rate and Forecast

The global epoprostenol sodium market is expected to grow at a compound annual growth rate (CAGR) of around 2-3% from 2025 to 2031. This growth is driven by the increasing demand for effective PAH treatments and the expanding patient population[3].

Revenue and Volume Share

The market revenue is projected to increase significantly, with the injection segment contributing the most to the overall revenue. The purity above 98% segment is also expected to dominate due to its higher efficacy and preference in clinical settings[5].

Combination Therapy and Future Trends

Shift to Combination Therapy

Current trends in PAH treatment are shifting towards combination therapy, which targets different mechanisms involved in the pathogenesis of PAH simultaneously. This approach has shown better outcomes in terms of survival and symptom relief compared to monotherapy. Combination therapies involving prostaglandins, endothelin receptor antagonists (ERAs), and phosphodiesterase 5 (PDE5) inhibitors are becoming more common[3].

Emerging Therapies

Newer therapeutic approaches, such as targeting the NO-sGC-cGMP pathway, are being explored. These emerging therapies hold promise for improving treatment outcomes and may further drive the growth of the epoprostenol sodium market as part of combination regimens[3].

Key Takeaways

• Clinical Efficacy: Epoprostenol sodium has demonstrated significant improvements in exercise capacity, hemodynamics, and quality of life in PAH patients.
• Market Growth: The global market is expected to grow at a CAGR of around 2-3% from 2025 to 2031, driven by increasing demand and advancements in treatment options.
• Segmentation: The injection segment and purity above 98% segment are expected to dominate the market.
• Combination Therapy: There is a growing trend towards combination therapy, which targets multiple pathways in PAH treatment.
• Emerging Trends: New therapeutic approaches, such as targeting the NO-sGC-cGMP pathway, are being developed to enhance treatment outcomes.

FAQs

What are the primary benefits of epoprostenol sodium in treating PAH?

Epoprostenol sodium improves exercise capacity, hemodynamics, and quality of life in PAH patients. It also reduces mortality rates compared to conventional therapy alone[4].

Which regions are expected to dominate the global epoprostenol sodium market?

North America and Europe are expected to dominate the market due to higher healthcare spending and greater awareness of PAH treatments[5].

What is the projected CAGR for the global epoprostenol sodium market?

The global epoprostenol sodium market is expected to grow at a CAGR of around 2-3% from 2025 to 2031[3].

What are the common side effects associated with epoprostenol sodium?

Common side effects include infusion-site pain, which can lead to discontinuation or limit dose increase, as well as other adverse events such as flushing of the skin and jaw pain[1][4].

How does combination therapy impact the treatment of PAH?

Combination therapy, which includes epoprostenol sodium along with other drugs like ERAs and PDE5 inhibitors, has shown better outcomes in terms of survival and symptom relief compared to monotherapy[3].

Sources

1. The new clinical trials on pharmacological treatment in pulmonary ... - ERS Publications
2. Global Epoprostenol Sodium Market Report 2024 Edition - Cognitive Market Research
3. Global Pulmonary Arterial Hypertension Market - iHealthcareAnalyst
4. VELETRI® (epoprostenol) Clinical Information for IPAH/HPAH - Veletri
5. Global epoprostenol sodium market size and forecast - Market Research Intellect