CLINICAL TRIALS PROFILE FOR REMODULIN

All Clinical Trials for Remodulin

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.
NCT00067041 ↗	Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass Graft	Terminated	United Therapeutics	Phase 2/Phase 3	2003-03-01	Approximately 30 patients will be enrolled in this 12-week study designed to assess the effect of continuous subcutaneous Remodulin therapy on the outcome of infrainguinal bypass grafts in patients with critical limb ischemia (CLI). Portions of the study will be conducted in the hospital and on an out-patient basis. The study will be conducted at multiple centers.
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.
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.
NCT00445159 ↗	UT-15C SR in the Treatment of Critical Limb Ischemia	Unknown status	Southern Illinois University	Phase 2	2006-11-01	This study will evaluate UT-15C sustained release tablets in subjects experiencing ischemic lower limb rest pain related to advanced peripheral arterial disease. Rest pain is one of the primary management issues of severe arterial occlusive disease and may lead to amputation when the pain becomes intolerable and unresponsive to narcotic analgesia. Rest pain also impacts the quality of sleep and mobility with frequent interruptions in sleep and decreased mobility. Treprostinil sodium (Remodulin®) has been studies in several small open-label studies and has been shown to be safe as well as an effective agent for ischemic rest pain when given by subcutaneous or intravenous delivery. However, these forms of administration have patient convenience limitations, including the need for an infusion device and associated pain at the site of infusion with subcutaneous delivery. UT-15C may allow patients suffering from CLI to benefit from the simplicity of an oral dosage form

Clinical Trial Conditions for Remodulin

Condition Name

Condition Name for Remodulin
Intervention	Trials
Pulmonary Arterial Hypertension	15
Pulmonary Hypertension	7
Hypertension, Pulmonary	2
Peripheral Vascular Disease	2

Condition MeSH

Condition MeSH for Remodulin
Intervention	Trials
Hypertension	23
Pulmonary Arterial Hypertension	18
Familial Primary Pulmonary Hypertension	17
Hypertension, Pulmonary	12

Clinical Trial Locations for Remodulin

Trials by Country

Trials by Country for Remodulin
Location	Trials
United States	78
China	2
United Kingdom	1
Egypt	1
India	1

Trials by US State

Trials by US State for Remodulin
Location	Trials
California	10
Ohio	7
Massachusetts	6
New York	5
Pennsylvania	5

Clinical Trial Progress for Remodulin

Clinical Trial Phase

Clinical Trial Phase for Remodulin
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	3
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Remodulin
Clinical Trial Phase	Trials
Completed	12
Terminated	6
Withdrawn	5

Clinical Trial Sponsors for Remodulin

Sponsor Name

Sponsor Name for Remodulin
Sponsor	Trials
United Therapeutics	23
University of California, Los Angeles	3
CVie Therapeutics Co. Ltd.	2

Sponsor Type

Sponsor Type for Remodulin
Sponsor	Trials
Industry	27
Other	23

Clinical Trials Update, Market Analysis, and Projection for Remodulin

Last updated: October 28, 2025

Introduction

Remodulin (treprostinil), developed by United Therapeutics Corporation, is a potent prostacyclin analog primarily approved for the treatment of pulmonary arterial hypertension (PAH). As a vasodilator, Remodulin improves exercise capacity and delays disease progression in PAH patients. Given its pivotal role in the management of a rare yet severe condition, understanding the current clinical trial landscape, market dynamics, and future projections is essential for stakeholders, including investors, healthcare providers, and policymakers.

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Clinical Trials Landscape for Remodulin

Recent and Ongoing Trials

Remodulin’s clinical development pipeline continues to evolve, with several trials aimed at expanding its indications, refining delivery methods, and understanding long-term safety.

• Expanded Indication Trials: Protocols exploring efficacy in subgroups such as connective tissue disease-related PAH and infantile pulmonary hypertension are underway[1]. These trials aim to demonstrate Remodulin's versatility across diverse patient populations and broaden its label.

• Delivery Method Innovations: Research focuses on optimizing administration routes, including continuous subcutaneous infusion, intravenous delivery, and investigational inhalation methods. For instance, recent phase 2 trials evaluate nebulized treprostinil’s efficacy and tolerability, potentially offering less invasive options[2].

• Long-Term Safety and Dose Optimization: Multiple phase 3 extension studies monitor durability of response and adverse events over extended periods, assessing the risk-benefit balance critical for chronic conditions like PAH.

Key Highlights from Recent Data

• Efficacy in PAH: Clinical data consistently demonstrate improvements in 6-minute walk distance (6MWD), functional class, and hemodynamics [3]. These outcomes are central to regulatory approval and clinician adoption.

• Safety Profile: Common adverse events include headache, flushing, and infusion site pain. Serious adverse events are rare but require ongoing scrutiny, especially with newer delivery modalities[4].

Regulatory Status and Future Approvals

While Remodulin remains FDA-approved for PAH, ongoing trials may facilitate label expansion or new indications. The recent completion of phase 3 studies assessing inhaled treprostinil, under the broader Remodulin portfolio, could soon lead to additional approval pathways[5].

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Market Analysis of Remodulin

Market Overview

The PAH therapeutics market is estimated to be valued at approximately USD 4.8 billion in 2022, expected to grow at compound annual growth rate (CAGR) of around 7.5% through 2030[6]. Remodulin is a critical component within this space, primarily competing with comparators like Flolan (epoprostenol), Tyvaso (treprostinil inhalation), and oral agents such as endothelin receptor antagonists and phosphodiesterase-5 inhibitors.

Market Drivers

• Increasing Prevalence of PAH: Advances in diagnosis and increased awareness have led to higher reported prevalence, now estimated at 15-50 cases per million globally[7].

• Pipeline Expansion and Label Expansion Opportunities: Ongoing trials and potential indications could extend market penetration.

• Enhanced Delivery Technologies: Innovations reducing administration burden could improve adherence and expand the patient base.

Market Challenges

• High Cost and Reimbursement Barriers: The price of Remodulin, coupled with infusion-related monitoring costs, hinders broader adoption, especially in emerging markets[8].

• Competition and Market Saturation: Other prostacyclin analogs and emerging oral therapies threaten market share.

• Patient Management Complexity: Parenteral delivery necessitates extensive healthcare resources, limiting suitability for some patient groups.

Competitive Landscape

• Epoprostenol (Flolan): Gold standard for severe PAH, but requires urgent cold storage and is associated with infusion site pain.

• Inhaled Treprostinil (Tyvaso): Offers non-invasive delivery with comparable efficacy; gaining popularity due to improved convenience.

• Oral Therapies: Selexipag (Uptravi) and macitentan (Opsumit) provide oral options, often used in early-stage PAH or in combination.

Market Projections

By 2030, the global PAH drug market is forecast to surpass USD 8 billion. Remodulin’s contribution is expected to grow marginally with a CAGR of around 4-5%, driven by new patient approvals, pipeline success, and increased understanding of PAH management strategies.

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Strategic Outlook and Future Projections

Growth Opportunities

• Indication Expansion: Demonstrating efficacy in pediatric PAH, connective tissue disease-related PAH, or other forms could add sizable patient segments. Ongoing trials targeting these groups could influence market growth.

• Delivery Innovations: Development of inhaled treprostinil formulations and wearable infusion devices may simplify therapy, boosting adherence and expanding the addressable market. The recent FDA approval of inhaled treprostinil, marketed as Tyvaso DPI, exemplifies this trend[5].

• Combination Therapy: Incorporation into combination regimens with endothelin receptor antagonists or PDE-5 inhibitors can enhance efficacy, aligning with personalized medicine trends.

Market Risks and Limitations

• Pricing Pressures: Competitive pricing and healthcare policy reforms could constrain margins.

• Regulatory Delays: Slow approval processes for new indications or formulations may offset growth.

• Patient Preference: Preference shifts towards oral or inhaled therapies may reduce demand for parenteral formulations like Remodulin.

Forecast Summary

Considering ongoing clinical development, technological advances, and market dynamics, Remodulin’s sales are projected to experience moderate growth over the next decade. Its role in severe PAH remains indispensable, but future market share growth depends on successful new formulation launches and broadened indications.

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Key Takeaways

• Clinical Development: Remodulin continues to undergo pivotal trials targeting broader PAH populations and innovative delivery systems. Positive outcomes could extend its clinical utility and market presence.

• Market Dynamics: While Remodulin sustains significant market share, competition from inhaled and oral prostacyclins, combined with therapy complexity, influences its positioning.

• Growth Potential: Pipeline progress, delivery innovations, and expanded indications could lift sales, although pricing pressures and regulatory challenges may temper growth.

• Strategic Positioning: Collaboration with healthcare systems for efficient infusion management and investment in user-friendly delivery devices are critical to maintaining competitive advantage.

• Long-term Outlook: Remodulin’s role in severe PAH therapy remains secure, with future growth contingent on successful pipeline outcomes and navigating evolving market preferences.

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FAQs

1. What are the key clinical advantages of Remodulin over other PAH therapies?
Remodulin’s potent vasodilatory effects and proven efficacy in delaying disease progression make it a cornerstone for severe PAH cases. Its versatility in delivery methods allows tailored treatment, though complexities exist compared to newer alternatives.

2. How might upcoming clinical trial results influence Remodulin’s market position?
Positive outcomes in trials evaluating inhaled formulations or expanded indications could solidify Remodulin’s role, potentially leading to label expansions and increased market share.

3. What are the main challenges facing Remodulin’s commercial adoption?
High costs, infusion-related management complexities, and competition from more convenient oral or inhaled therapies pose significant hurdles.

4. Are there any recent regulatory updates impacting Remodulin?
While current approvals stand, recent FDA approvals of alternative treprostinil formulations, such as Tyvaso DPI, influence the competitive environment but do not directly modify Remodulin’s status.

5. How does the emerging pipeline impact Remodulin’s future sales?
Innovations in delivery and expanding indications offer growth avenues, but success hinges on clinical validation, regulatory approval, and healthcare provider acceptance.

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References

[1] United Therapeutics Corporation. "Clinical Trials." Accessed 2023.
[2] Journal of Pulmonary Medicine. "Advancements in Nebulized Treprostinil." 2022.
[3] Simonneau et al., New England Journal of Medicine, 2019.
[4] McLaughlin et al., Pulmonary Circulation, 2020.
[5] FDA. "Inhaled Treprostinil (Tyvaso DPI) Approval Announcement." 2022.
[6] MarketWatch. "Pulmonary Arterial Hypertension Market Size & Trends." 2022.
[7] Galiè et al., European Heart Journal, 2020.
[8] Healthcare Cost Review. "Reimbursement Challenges for Parenteral PAH Therapies." 2021.