Pharmaceutical sponsor
United Therapeutics Clinical Trials
Studies where United Therapeutics is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 8Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
The purpose of this study is to evaluate the long-term impact of treprostinil SMI on safety and efficacy by providing it to PH-COPD patients who participated in a preceding Phase 2 or 3 study.
- Trial name
- SUMMIT OLE (NCT07923526)
- Testing
- treprostinil SMI (treprostinil inhalation spray)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- United Therapeutics
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
The primary purpose of this study is to evaluate the safety and tolerability of treprostinil administered with a soft mist inhaler (SMI) over 16 weeks in approximately 40 participants with PH-COPD.
- Trial name
- SUMMIT 201 (NCT07923591)
- Testing
- treprostinil SMI (treprostinil inhalation spray)
- Where
- 16 sites in United States
- Volunteers
- 40 people
- Sponsor
- United Therapeutics
Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis
- Trial name
- TETON-OLE (NCT04905693)
- Testing
- Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
- Where
- 192 sites in United States, Argentina and 16 more
- Volunteers
- 1,850 people
- Sponsor
- United Therapeutics
PAH, Pulmonary Hypertension
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
- Conditions
- PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension
- Trial name
- NCT03683186
- Testing
- Ralinepag
- Where
- 190 sites in United States, Argentina and 31 more
- Volunteers
- 1,000 people
- Sponsor
- United Therapeutics
ESRD (End-Stage Renal Disease), Kidney Transplantation
Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD
The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1)…
- Conditions
- ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
- Trial name
- EXTEND (NCT07224763)
- Testing
- GGTA1 KO Thymokidney
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United Therapeutics
Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension
DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
This is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).
- Conditions
- Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease
- Trial name
- NCT06388421
- Testing
- Prospective study assessments
- Where
- 71 sites in United States, Puerto Rico
- Volunteers
- 900 people
- Sponsor
- United Therapeutics
Progressive Pulmonary Fibrosis, Interstitial Lung Disease
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
- Trial name
- NCT05943535
- Testing
- Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
- Where
- 165 sites in United States, Argentina and 13 more
- Volunteers
- 698 people
- Sponsor
- United Therapeutics
ESRD (End-Stage Renal Disease), Kidney Transplantation
Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD
The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ…
- Conditions
- ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation
- Trial name
- EXPAND (NCT06878560)
- Testing
- 10 GE Xenokidney
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- United Therapeutics
Completed, with results posted
All 28Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease
Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis
Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.
- Trial name
- TETON-2 (NCT05255991)
- Testing
- Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
- Where
- 108 sites in Argentina, Australia and 14 more
- Volunteers
- 597 people
- Sponsor
- United Therapeutics
PAH
Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years
This was a multi-center, open-label, safety, tolerability and pharmacokinetic study of oral treprostinil in pediatric subjects with stable PAH aged 7 to 17 years who were (1) transitioning from parenteral Remodulin therapy; (2)…
- Trial name
- NCT02276872
- Testing
- oral treprostinil
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- United Therapeutics
Pulmonary Arterial Hypertension
Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso
This was a Phase 1b safety and tolerability single-sequence study in which PAH subjects on a stable regimen of Tyvaso switched to a corresponding dose of TreT.
- Trial name
- BREEZE (NCT03950739)
- Testing
- Treprostinil Inhalation Powder
- Where
- 16 sites in United States
- Volunteers
- 51 people
- Sponsor
- United Therapeutics
Pulmonary Arterial Hypertension
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study RIV-PH-402 were eligible to enroll.
- Trial name
- TRUST-2 (NCT03055221)
- Testing
- Intravenous Treprostinil
- Volunteers
- 20 people
- Sponsor
- United Therapeutics
Pulmonary Hypertension
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
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.
- Trial name
- NCT00325403
- Testing
- Oral treprostinil (UT-15C) Sustained Release Tablets
- Where
- 77 sites in United States, Austria and 11 more
- Volunteers
- 349 people
- Sponsor
- United Therapeutics