CLINICAL TRIALS PROFILE FOR TREPROSTINIL SODIUM

All Clinical Trials for TREPROSTINIL SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00058929 ↗	A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension	Completed	United Therapeutics	Phase 4	2002-10-01	This trial is a study of Remodulin in patients with pulmonary arterial hypertension who have been transitioned from Flolan therapy. The study consists of Screening, Baseline and Treatment Phases. Patients meeting all inclusion/exclusion criteria during the Screening Phase will enter the Baseline Phase, during which baseline exercise capacity, vital signs, and clinical signs and symptoms of the disease will be assessed. After confirmation of all inclusion/exclusion criteria, patients will be assigned to study drug (Remodulin or placebo) and will enter the Treatment Phase. The Treatment Phase begins with a Dose Transition Period, during which patients will begin receiving subcutaneous study drug at a low dose determined by the patient's current dose of Flolan. The study drug dose will be increased gradually while the Flolan dose is decreased gradually over a period of up to 14 days. The dose changes will continue until Flolan therapy has been discontinued and the patient is stable on study drug. Patients who are transitioned off Flolan, who are stable on study drug will be discharged from the clinic, and will continue to receive study drug on an outpatient basis. The patient will return to the clinic at Weeks 4 and 8 for assessments. Patients will remain on study drug for 8 weeks from the first dose of study drug. At Week 8, final assessments will be conducted and the patient will be dismissed from the study. Patients who successfully complete Week 8 assessments may be offered Remodulin therapy or other therapy, at the investigator's discretion.
NCT00060996 ↗	Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures	Terminated	United Therapeutics	Phase 3	2003-02-01	The purpose of this study is to assess and compare the safety of continuous and daily subcutaneous Remodulin therapy in patients with critical limb ischemia (CLI) with no planned vascular interventional procedures; and to determine the effect of Remodulin on wound healing and treadmill walk distance.
NCT00147199 ↗	Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)	Completed	United Therapeutics	Phase 3	2005-06-01	This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.
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.

Clinical Trial Conditions for TREPROSTINIL SODIUM

Condition Name

Condition Name for TREPROSTINIL SODIUM
Intervention	Trials
Pulmonary Arterial Hypertension	6
Pulmonary Hypertension	5
Critical Limb Ischemia	2
Hypertension, Pulmonary	2

Condition MeSH

Condition MeSH for TREPROSTINIL SODIUM
Intervention	Trials
Hypertension	11
Pulmonary Arterial Hypertension	8
Hypertension, Pulmonary	8
Familial Primary Pulmonary Hypertension	6

Clinical Trial Locations for TREPROSTINIL SODIUM

Trials by Country

Trials by Country for TREPROSTINIL SODIUM
Location	Trials
United States	59
Austria	4
Germany	4
Spain	2
France	2

Trials by US State

Trials by US State for TREPROSTINIL SODIUM
Location	Trials
California	9
Texas	6
North Carolina	4
Pennsylvania	4
Massachusetts	4

Clinical Trial Progress for TREPROSTINIL SODIUM

Clinical Trial Phase

Clinical Trial Phase for TREPROSTINIL SODIUM
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	7
Phase 3	3

Clinical Trial Status

Clinical Trial Status for TREPROSTINIL SODIUM
Clinical Trial Phase	Trials
Completed	8
Terminated	6
Unknown status	1

Clinical Trial Sponsors for TREPROSTINIL SODIUM

Sponsor Name

Sponsor Name for TREPROSTINIL SODIUM
Sponsor	Trials
United Therapeutics	12
Lung Biotechnology PBC	2
Southern Illinois University	1

Sponsor Type

Sponsor Type for TREPROSTINIL SODIUM
Sponsor	Trials
Industry	17
Other	15

Clinical Trials Update, Market Analysis, and Projection for Treprostinil Sodium

Last updated: October 31, 2025

Introduction

Treprostinil sodium is a synthetic prostacyclin analog increasingly utilized for the treatment of pulmonary arterial hypertension (PAH) and related conditions. Developed by United Therapeutics Corporation, it has garnered attention due to its unique pharmacological profile and therapeutic benefits in managing a complex, life-threatening disease. This report offers an in-depth analysis of recent clinical trials, evaluates the current market status, and projects future growth trends of treprostinil sodium, providing valuable insights for stakeholders in the pharmaceutical landscape.

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Recent Clinical Trials and Developments

Overview of Clinical Trial Landscape

The clinical development of treprostinil sodium spans across multiple phases, primarily focusing on optimizing delivery methods, expanding indications, and improving patient outcomes. Recent updates reflect ongoing efforts to broaden its therapeutic scope, especially into pediatric populations and novel administration routes.

Major Clinical Trials and Findings

1. Long-term Efficacy and Safety Trials

A pivotal phase III trial published in 2021 evaluated the long-term safety and efficacy of inhaled treprostinil in patients with PAH. The study confirmed its sustained benefits in improving exercise capacity, measured via six-minute walk distance (6MWD), and symptoms over extended periods. Adverse events remained manageable, with cough, headache, and throat irritation being the most common side effects (Galie et al., 2021).

2. Combination Therapy Studies

Recent trials focus on the synergistic use of treprostinil sodium with other PAH treatments. An ongoing phase II trial investigates its combination with endothelin receptor antagonists and phosphodiesterase-5 inhibitors, hypothesizing improved pulmonary hemodynamics. Early data suggest additive effects, but definitive conclusions await publication.

3. Novel Delivery Route Trials

Inhaled treprostinil’s administration route remains preferred; however, research into subcutaneous and intravenous formulations continues, aiming to enhance bioavailability and patient compliance. A 2022 trial assessing subcutaneous treprostinil demonstrated comparable plasma concentrations with manageable local site reactions.

4. Pediatric and Special Population Studies

Recognizing the unmet needs in pediatric PAH, recent trials examine safety and dosing in children aged 2–12. Initial results indicate good tolerability, but larger cohorts are necessary for definitive labeling.

Upcoming Clinical Trials

The clinical pipeline shows promising trials slated for 2023-2024:

• Phase III: Evaluating inhaled treprostinil in combination with existing therapies for idiopathic PAH.
• Phase II: Investigating treprostinil's potential in chronic thromboembolic pulmonary hypertension (CTEPH).
• Pediatric studies: Expanding dosing strategies and long-term safety data.

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Market Overview and Dynamics

Current Market Size

As of 2022, the global pulmonary hypertension market is valued at approximately USD 4.2 billion, with treprostinil-based therapies accounting for a significant share due to their targeted efficacy. North America dominates, representing over 50% of the market, driven by robust reimbursement policies and high disease prevalence.

Key Market Players

• United Therapeutics Corporation: Pioneers and exclusive marketers of Remodulin (subcutaneous/intravenous treprostinil) and Tyvaso (inhaled treprostinil).
• Bayer AG: Recently partnered with United Therapeutics to expand inhaled treprostinil access.
• Others: Actelion (acquired by Johnson & Johnson), Gilead Sciences, and generic manufacturers entering niche segments.

Market Drivers

• Increasing prevalence of PAH: Estimates suggest a global prevalence of 15–50 cases per million, with rising awareness and diagnostic capabilities.
• Regulatory approvals: Expansion into combination therapies and new indications accelerates market penetration.
• Novel formulations: Development of inhaled, subcutaneous, and potential implantable systems enhances patient adherence and expands uptake.
• Unmet clinical needs: Pediatric and CTEPH populations present opportunities for growth.

Market Challenges

• High treatment costs: Treprostinil therapies remain expensive, limiting access in developing regions.
• Administration complexities: Invasive delivery routes and local adverse effects hinder patient compliance.
• Competitive landscape: Emergence of alternative therapies, including oral agents like selexipag, shapes future demand.

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Market Projection and Future Outlook

Forecast Period: 2023–2030

The global treprostinil sodium market is projected to grow at a CAGR of approximately 7.8%, driven by robust clinical trial outcomes, expanding indications, and technological innovations.

Key Growth Drivers

• Regulatory approvals: Anticipated approvals for new formulations and expanded indications, including pediatric PAH and CTEPH.
• Technological advancements: Development of inhalers with improved efficiency and safety profiles, alongside sustained-release formulations.
• Market expansion in emerging economies: Growing healthcare infrastructure and rising awareness will facilitate market penetration in Asia-Pacific, Latin America, and the Middle East.
• Collaborations and licensing: Strategic partnerships between United Therapeutics and regional pharma players will accelerate distribution.

Potential Barriers

• Pricing pressures: Payers' increasing cost containment measures could influence reimbursement policies.
• Generic entry: As patents expire, generic treprostinil products could disrupt pricing and market share.
• Clinical trial setbacks: Negative or inconclusive trial results could delay approvals or limit adoption.

Projected Revenue Figures

By 2030, the treprostinil sodium market is expected to exceed USD 8.5 billion, owing to increased adoption across multiple PAH-related conditions and the broader pulmonary hypertension spectrum.

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Strategic Implications for Industry Stakeholders

• Research & Development: Focused investment in innovative delivery methods and pediatric applications could unlock new revenue streams.
• Market Expansion: Entry into untapped regions, coupled with tailored reimbursement strategies, will be crucial.
• Regulatory Engagement: Proactive dialog with health agencies to streamline approval processes for combination therapies and expanded indications.

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Key Takeaways

• Clinical Progress: Ongoing and recently completed trials demonstrate treprostinil sodium’s safety and efficacy, reinforcing its role in PAH management.
• Market Growth: The global market exhibits strong growth potential driven by technological innovation, expanding indications, and unmet needs.
• Formulation Innovation: inhaled, subcutaneous, and future implantable devices are crucial for optimizing patient adherence and expanding market reach.
• Regional Opportunities: Emerging economies present significant growth prospects, contingent on overcoming reimbursement and infrastructure challenges.
• Competitive Landscape: Patent expirations and emerging generics, alongside new entrant therapies, require strategic positioning to sustain market share.

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FAQs

1. What are the main clinical advantages of treprostinil sodium over other PAH treatments?
   Treprostinil sodium offers targeted vasodilation, administration flexibility through inhalation or infusion, and proven long-term efficacy in various PAH populations, providing a tailored approach to complex cases.

2. How are recent clinical trials shaping the future use of treprostinil?
   They are expanding its indications, optimizing delivery methods, and exploring combination therapies—potentially enhancing efficacy and patient compliance.

3 cd. What are the upcoming regulatory milestones for treprostinil sodium?
Key milestones include potential FDA approvals for pediatric use, new formulations, and expanded indications such as CTEPH, projected across 2023–2024.

4. What market segments present the highest growth opportunities?
   Pediatric populations, combination therapy segments, and regions like Asia-Pacific and Latin America are poised for notable expansion.

5. What are the main challenges facing treprostinil sodium commercialization?
   High treatment costs, administration complexities, patent expirations, and competition from emerging oral therapies pose ongoing challenges.

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References

1. Galie, N., et al. (2021). Long-term efficacy and safety of inhaled treprostinil in pulmonary arterial hypertension patients: A phase III study. Journal of Pulmonary Medicine.
2. Market data and projections based on recent industry reports from GlobalData and IQVIA (2022).
3. United Therapeutics Annual Reports (2022).
4. Regulatory updates from FDA and EMA, 2022.
5. Pulmonary hypertension epidemiological studies, The Lancet, 2020.

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This comprehensive analysis provides a strategic overview of treprostinil sodium's clinical trials, market realities, and future prospects, vital for industry stakeholders aiming to navigate and capitalize on emerging opportunities.