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.
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
NCT00445159 ↗	UT-15C SR in the Treatment of Critical Limb Ischemia	Unknown status	Southern Arizona Vascular Institute	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 treprostinil sodium

Condition Name

Condition Name for treprostinil sodium
Intervention	Trials
Pulmonary Arterial Hypertension	6
Pulmonary Hypertension	5
Hypertension, Pulmonary	2
Critical Limb Ischemia	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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	1

Sponsor Type

Sponsor Type for treprostinil sodium
Sponsor	Trials
Industry	17
Other	15

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

Last updated: April 30, 2026

What is treprostinil sodium and where is it used?

Treprostinil sodium is a prostacyclin-pathway therapy used for pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) in patients who are not candidates for surgery or have persistent/recurrent disease after surgery. In the market, treprostinil is sold across multiple delivery formats (parenteral and inhaled) and is positioned as a core prostacyclin agent for PAH escalation pathways.

Key brands by format:

• Remodulin (treprostinil)
• Tyvaso (treprostinil) / Tyvaso DPI
• Orenitram (treprostinil) (Brands vary by approval scope and route.)

How is treprostinil sodium positioned in the clinical pipeline?

As a platform drug with an established label, treprostinil’s clinical activity in recent years has skewed toward:

• label expansions and population refinements (PAH subgroups, functional class strata)
• comparative or combination studies versus other PAH therapies
• pharmacokinetic (PK) and device-related programs for inhaled formulations (including DPI evolutions)

Clinical trial activity summary (recent-to-current)

Clinical-trial disclosures for treprostinil typically cluster around:

• PAH severity stratification (e.g., WHO functional class; background therapy)
• CTEPH endpoints (exercise capacity and hemodynamics)
• formulation/device endpoints (inhaled exposure matching, tolerability, adherence)

Endpoint patterns used across treprostinil trials:

• 6-minute walk distance (6MWD)
• cardiopulmonary hemodynamics (e.g., pulmonary vascular resistance, cardiac index)
• time-to-clinical-worsening composite endpoints (in some newer designs)
• safety and prostacyclin-class tolerability (flushing, headache, jaw pain, diarrhea, infusion-site pain)

Source basis: trial listings and updates on clinical registries and sponsor postings, which in aggregate show treprostinil programs concentrated in PAH/CTEPH and inhaled formulation/device cohorts. (Clinical-trial registry sources are cited below.)

What do the most recent and ongoing studies indicate?

The practical signal for commercial planning is that treprostinil continues to be used in:

• earlier escalation strategies (background combination regimens)
• continuity of prostacyclin therapy across devices and routes
• ongoing reinforcement of inhaled therapy adherence via device evolution (nebulized to DPI where approved)

For business planning, the clinically relevant implication is consistency:

• inhaled treprostinil remains the main route for office-friendly administration compared with continuous infusion
• parenteral treprostinil remains the escalation anchor for severe disease and treatment failures on oral therapy

What is the competitive landscape for treprostinil sodium in PAH and CTEPH?

Treprostinil competes in a multi-class PAH market:

• Prostacyclin pathway: treprostinil (Remodulin, Tyvaso/Tyvaso DPI, Orenitram) vs prostacyclin analogs and prostacyclin receptor agonists (e.g., selexipag; parenteral prostacyclin analogs)
• Endothelin pathway: ERAs (bosentan, ambrisentan, macitentan)
• NO-sGC pathway: PDE5 inhibitors and sGC stimulators (sildenafil, tadalafil, riociguat)

Commercial driver: prostacyclin therapies are the most clinically active class for advanced symptoms, and treprostinil’s multi-route portfolio helps capture different patient and payer needs, reducing switching friction across the disease course.

How big is the treprostinil sodium addressable market?

The addressable segment is defined by:

• Diagnosed PAH populations (incident and prevalent)
• Diagnosed CTEPH populations not amenable to curative surgery or with persistent disease post-procedure
• Treated patients on prostacyclin pathway escalation or those who meet criteria for initiation of prostacyclin therapy

Market sizing depends on epidemiology assumptions and diagnosis capture rate, but the key business reality is that treprostinil already occupies a central position in PAH treatment algorithms. The market is also durable because PAH is chronic and treatment continues long-term.

Treatment algorithm dynamics that support demand stability

Clinical guidelines used by payers and prescribers generally support stepwise escalation:

• initial dual/triple oral therapy in many patients
• earlier prostacyclin initiation in higher-risk profiles
• route choice influenced by severity, patient preference, and logistics

Treprostinil benefits from this structure because it covers:

• parenteral escalation (continuous infusion)
• inhaled prostacyclin delivery (stepwise addition and dose titration)
• oral prostacyclin analog delivery (maintenance and transition)

What are the price-and-utilization levers for revenue growth?

Treprostinil revenue growth is most sensitive to:

1. Dose intensity and titration: PAH therapy is titrated to effect, and prostacyclin-class AEs can slow titration in some patients but do not eliminate dosing escalation.
2. Route shift and device adoption: inhaled formulations and device iterations can improve adherence and reduce administration burden, supporting retention and uptake.
3. Patient mix: expansion into more severe or earlier escalation subgroups typically increases average patient treatment intensity.
4. Payer coverage and prior authorization outcomes: prostacyclin drugs face managed-entry barriers; successful formulary placement materially changes net sales.
5. Switching dynamics within prostacyclin class: patients who fail one route may switch to another treprostinil route rather than abandoning the class.

What is the market projection for treprostinil sodium?

A defensible projection framework is built on:

• PAH and CTEPH diagnosis trends
• therapy persistence and duration
• share capture within prostacyclin pathway
• new patient starts by route
• competitive attrition due to alternative prostacyclin agents

Projection mechanics (directional)

Treprostinil’s topline outlook generally trends with:

• stable or slightly expanding treated populations (diagnosis + treatment initiation)
• continued route portfolio capture (parenteral for advanced, inhaled for convenience, oral for maintenance)
• pricing pressure balanced by mix shift and dose intensity

Projection ranges (high-level)

Because treprostinil market performance is dependent on net pricing, rebates, and payer arrangements by geography, a single point estimate is not actionable without company financials and segment-level reimbursement detail. However, the business decision is typically about directionality and sensitivity:

• Base case: moderate growth driven by continued prostacyclin share retention and route substitution within treprostinil portfolio.
• Upside case: sustained inhaled adoption and faster conversion of diagnosed patients into prostacyclin initiation.
• Downside case: managed-care restrictiveness, competitive substitution within prostacyclin class, or adverse payer policy limiting dose escalation.

The key commercial takeaway: treprostinil is positioned for durable revenue because it spans multiple administration modalities, which reduces churn when patient needs change over the disease course.

What regulatory events matter most for treprostinil sodium?

For treprostinil, the most consequential regulatory items typically include:

• labeling updates for PAH and CTEPH populations
• approvals of new formulations or devices (notably inhaled transitions such as DPI pathways when approved)
• safety updates impacting dose titration, contraindications, or risk mitigation

These items influence physician adoption and payer coverage, which drive utilization and persistence.

What could change the treprostinil sodium market trajectory?

Key inflection points:

• Inhaled device uptake and payer acceptance: improves ease of use and may expand eligible patients.
• Comparative effectiveness data: if trials strengthen endpoints for specific subgroups or routes.
• Safety/tolerability patterns: prostacyclin class AEs influence titration tempo and adherence.
• Competition and sequencing: prostacyclin receptor agonists and alternative analogs can take share if efficacy and logistics favor them.
• Health-system protocols: standardized escalation pathways influence how quickly clinicians move to prostacyclin.

Clinical and commercial fact base: what the data sources cover

For analysis and verification, the most reliable sources are:

• clinical trial registries tracking recruitment, results, and updates
• regulatory and label documentation through official drug databases and approval histories
• guideline documents that define care pathways and prostacyclin initiation criteria

These sources are cited below.

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Key Takeaways

• Treprostinil sodium is a multi-route prostacyclin-pathway therapy central to PAH and CTEPH escalation, with brand coverage across parenteral, inhaled, and oral formats.
• Clinical activity remains focused on PAH/CTEPH population refinement and inhaled formulation/device evolution, with standard prostacyclin endpoints (6MWD and hemodynamics) dominating trial designs.
• Commercial demand is driven by persistence, dose titration, and route flexibility, which reduces switching friction across the disease course.
• Market projection is best framed as durable moderate growth with upside tied to inhaled adoption and conversion to prostacyclin initiation, and downside tied to payer restrictiveness and competitive substitution within prostacyclin therapy.

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FAQs

1) What diseases does treprostinil sodium treat?

It treats pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) under labeled indications depending on route and product.

2) Which treprostinil routes drive most commercial uptake?

Commercial uptake typically clusters around inhaled therapy for broader patient convenience and parenteral therapy for advanced disease where continuous infusion is used.

3) What endpoints do treprostinil trials most commonly use?

Common endpoints include 6-minute walk distance (6MWD), hemodynamic measures such as pulmonary vascular resistance, and composite measures of clinical worsening depending on trial design.

4) What is the most important competitive threat to treprostinil?

Threat comes from alternative prostacyclin pathway options and class-level sequencing changes in PAH guidelines and managed-care formularies that restrict route access or dose titration.

5) What are the primary drivers of revenue growth?

The dominant drivers are dose intensity and persistence, route/device adoption (especially inhaled formats), and patient mix shift toward earlier or higher-risk initiation.

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References

[1] ClinicalTrials.gov. Treprostinil clinical trials registry (search results and study listings). https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drug approval information and labeling references for treprostinil products (Remodulin, Tyvaso, Orenitram). https://www.accessdata.fda.gov/
[3] European Medicines Agency. Public assessment and product information for treprostinil-related medicines. https://www.ema.europa.eu/
[4] Pulmonary arterial hypertension management guideline documents (PAH treatment pathway and prostacyclin initiation criteria). https://www.atsjournals.org/ (and related guideline repositories)