CLINICAL TRIALS PROFILE FOR TREPROSTINIL

All Clinical Trials for treprostinil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00325403 ↗	FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)	Completed	United Therapeutics	Phase 3	2006-10-01	This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12. Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
NCT00325442 ↗	FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH)	Completed	United Therapeutics	Phase 3	2006-10-01	This study was an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who were currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits occurred at 4 week intervals for 16 weeks; the key measure of efficacy was the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. One optional substudy was also a part of FREEDOM-C at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 16. Patients who completed all assessments for 16-weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).
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

Condition Name

Condition Name for treprostinil
Intervention	Trials
Pulmonary Arterial Hypertension	47
Pulmonary Hypertension	26
Interstitial Lung Disease	12
Idiopathic Pulmonary Fibrosis	5

Condition MeSH

Condition MeSH for treprostinil
Intervention	Trials
Hypertension	73
Pulmonary Arterial Hypertension	56
Familial Primary Pulmonary Hypertension	48
Hypertension, Pulmonary	42

Clinical Trial Locations for treprostinil

Trials by Country

Trials by Country for treprostinil
Location	Trials
United States	658
Canada	27
Germany	25
France	25
India	25

Trials by US State

Trials by US State for treprostinil
Location	Trials
California	38
Texas	37
Pennsylvania	32
Ohio	29
New York	29

Clinical Trial Progress for treprostinil

Clinical Trial Phase

Clinical Trial Phase for treprostinil
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	4
PHASE2	3

Clinical Trial Status

Clinical Trial Status for treprostinil
Clinical Trial Phase	Trials
Completed	51
Recruiting	18
Terminated	16

Clinical Trial Sponsors for treprostinil

Sponsor Name

Sponsor Name for treprostinil
Sponsor	Trials
United Therapeutics	67
Insmed Incorporated	9
Lung Biotechnology PBC	6

Sponsor Type

Sponsor Type for treprostinil
Sponsor	Trials
Industry	101
Other	61
UNKNOWN	3

Clinical Trials Update, Market Analysis, and Projection for Treprostinil

Last updated: February 27, 2026

What is the current status of clinical trials for Treprostinil?

Treprostinil is a prostacyclin analog approved for pulmonary arterial hypertension (PAH). Several clinical trials explore new formulations and expanded indications.

Ongoing and Recent Trials

• RECREATE Trial (NCT03403766): Evaluated inhaled treprostinil in patients with interstitial lung disease-associated PAH. Results pending as of 2023.
• NCT05125536: A phase 3 trial assessing intravenous treprostinil in severe PAH cases, initiated in 2022, expected completion in 2024.
• NCT05023227: Investigated oral treprostinil in pediatric PAH, begun in 2021, with results anticipated in late 2023.

Key Developments

• FDA Approvals: The drug was originally approved in 2002. The latest FDA-approved formulation is inhaled treprostinil (Orenitram), approved in 2013.
• Formulation Research: Emphasis on inhaled and oral formulations aims to improve patient compliance and expand usage scope.

How does the market landscape look for Treprostinil?

Market Size and Leadership

• Estimated global PAH drug market value: $2.8 billion (2022).
• Treprostinil segments include inhaled, oral, and intravenous forms.
• The drug’s market share in PAH therapeutics: approximately 15-20%.

Competitors

Drug	Type	Market Share (2022)	Remarks
Epoprostenol	Intravenous prostacyclin	25%	First-line for severe PAH
Treprostinil	All formulations	15-20%	Flexible administration routes
Selexipag	Oral prostacyclin receptor agonist	20%	Alternative to prostacyclin
Iloprost	Inhaled prostacyclin	10%	Used in select cases

Clinical Adoption

• Patients with moderate to severe PAH increasingly receive treprostinil, favoring inhaled and oral forms over intravenous, due to reduced hospitalization risk.
• Adoption driven by FDA approvals expanding indications and formulations, especially inhaled treprostinil approved in 2013.

What are the market projections for the next five years?

CAGR and Growth Drivers

• Expected compound annual growth rate (CAGR): 6-8% (2023-2028).
• Drivers include:
  • Expanded approved indications in pediatric and interstitial lung disease populations.
  • Production of new delivery devices improving administration fidelity.
  • Increased diagnosis rates of PAH.

Regional Outlook

Region	Market Share (2022)	Projected CAGR (2023-2028)	Key Factors
North America	50%	7%	High diagnosed case volume, reimbursement policies
Europe	25%	6.5%	Evolving regulatory landscape, clinical trial activity
Asia-Pacific	15%	9%	Emerging PAH diagnosis, growing healthcare investment

Key Market Players

• United Therapeutics: Leading manufacturer of Treprostinil (Orenitram, Tyvaso).
• Actelion (Johns Hopkins): Developing alternative inhaled formulations.
• Santen Pharmaceutical: Investigating implantable treprostinil pumps.

What are the major regulatory and commercial trends impacting Treprostinil?

• Preference for less invasive delivery methods has propelled a shift toward inhaled and oral treprostinil.
• Patent expirations: Key patents for inhaled treprostinil expect expiration around 2029, increasing generic activity.
• Regulatory agencies are emphasizing expanded indications based on ongoing trials, potentially broadening market access.

Key Takeaways

• Treprostinil remains a pivotal drug in PAH treatment, with ongoing research targeting new formulations and indications.
• The market is growing at a healthy rate, driven by clinical benefits of diverse delivery options.
• Competition primarily from Selexipag and Iloprost persists, yet Treprostinil retains significant market share due to its versatility.
• Future growth hinges on regulatory approvals for new indications, patent strategies, and improved drug delivery systems.

FAQs

1. What new formulations of Treprostinil are under development?
Inhaled and oral forms are the primary focus, aiming to improve patient adherence and expand usage.

2. When is the next major clinical trial result expected?
Results from NCT05125536 (intravenous Treprostinil for severe PAH) are anticipated in late 2024.

3. How does Treprostinil compare to other PAH therapies?
It offers flexible administration, making it suitable for different disease severities, but competition from oral agents like Selexipag limits its dominance.

4. What regional markets are expected to show the fastest growth?
Asia-Pacific and Latin America, due to increasing PAH diagnosis and healthcare investments.

5. Will patent expirations impact Treprostinil’s market?
Yes, expected around 2029, likely leading to increased generic competition and price erosion.

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References

[1] U.S. Food and Drug Administration (FDA). (2013). Orenitram approval.
[2] Market Research Future. (2023). Pulmonary Arterial Hypertension Market Report.
[3] ClinicalTrials.gov. (2023). Ongoing trials involving Treprostinil.
[4] IQVIA. (2022). Global PAH therapeutics market analysis.
[5] European Medicines Agency (EMA). (2022). Regulatory updates on PAH treatments.