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Clinical trials
catalyst calendar across sponsors →Studies where UTHR is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
74 interventional · 9 observational · 39 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)NCT06388421observationalBaseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values. | — | Recruiting | Other: Prospective study assessments | Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Interstitial Lung Disease | 900 | 2030-09-01 | in 1,474 d | 2026-06-10 |
| Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung DiseaseNCT04905693Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPFOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Inhaled Treprostinil · Device: Treprostinil Ultrasonic Nebulizer | Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis | 1,850 | Dec 2029 | ≤ 1,230 d | 2026-07-28 |
| Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRDNCT07224763Survival Rate of Patients with ESRD Receiving the GGTA1 KO Thymokidney at 24 Weeks Post TransplantOpen-label · Treatment | Phase 1/2 | Recruiting | Biological: GGTA1 KO Thymokidney | ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation | 50 | Mar 2029 | ≤ 955 d | 2026-05-27 |
| Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRDNCT06878560Survival Rate of Patients with ESRD Receiving the 10 GE Xenokidney at 24 Weeks Post TransplantOpen-label · Treatment | Phase 1/2 | Recruiting | Biological: 10 GE Xenokidney | ESRD (End-Stage Renal Disease), Kidney Transplantation, Xenotransplantation | 50 | Oct 2028 | ≤ 804 d | 2026-03-27 |
| Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)NCT05943535Change in Absolute FVC from Baseline to Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Placebo, Inhaled Treprostinil · Device: Treprostinil Ultrasonic Nebulizer | Progressive Pulmonary Fibrosis, Interstitial Lung Disease | 698 | Nov 2027 | ≤ 468 d | 2026-07-13 |
| ADAPT - A Patient Registry of the Real-world Use of Orenitram®NCT03045029observationalReal-world use and tolerability of Orenitram in new starts and prostacyclin transition patients | — | Active, not recruiting | Drug: Oral treprostinil | Pulmonary Arterial Hypertension | 300 | Mar 2027 | ≤ 224 d | 2026-04-02 |
| A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionNCT03683186Number of subjects with treatment-emergent adverse events [Safety and Tolerability]Open-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Ralinepag | PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease | 1,000 | Dec 2026 | ≤ 134 d | 2026-02-20 |
| A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial HypertensionNCT05203510Change From Baseline in Right Ventricular Ejection Fraction (RVEF), as Measured by Cardiac Magnetic Resonance Imaging (cMRI) at Month 12Open-label · Treatment | Phase 4 | Active, not recruiting | Drug: Parenteral Treprostinil, Oral Treprostinil | Pulmonary Arterial Hypertension | 52 | 2026-04-30 | — | 2025-12-09 |
| Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier DetectionNCT05776225observationalPercentage of patients with PH as indicated by RHC | — | Completed | Procedure: Right heart catheterization (RHC) | Interstitial Lung Disease, Pulmonary Hypertension | 314 | 2026-03-13actual | — | 2026-05-28 |
| Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisNCT04708782Change in Absolute FVC from Baseline to Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Inhaled Treprostinil · Device: Treprostinil Ultrasonic Nebulizer | Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease | 598 | 2026-02-02actual | — | 2026-05-05 |
| A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsNCT03626688Time from randomization to the first adjudicated protocol-defined clinical worsening eventRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Ralinepag, Placebo | PAH, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Hypertension, Pulmonary, Lung Diseases, Respiratory Tract Disease | 687 | 2025-12-31actual | — | 2026-06-16 |
| Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary FibrosisNCT05255991Change in Absolute FVC from Baseline to Week 52Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Placebo, Inhaled Treprostinil · Device: Treprostinil Ultrasonic Nebulizer | Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease | 597 | 2025-06-30actual | — | 2025-08-15 |
| Evaluate Real-World Use of Next Generation Infusion Pumps to Administer RemodulinNCT05060315observationalTo observe and assess time spent on drug administration activities related to the United Therapeutics Corp.-developed next generation pumps to administer Remodulin in patients with PAH | — | Terminatedsponsor's stated reason: Sponsor Decision | Combination product: Remunity Pump for Remodulin | Pulmonary Arterial Hypertension | 9 | 2024-12-31actual | — | 2025-01-16 |
| Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoNCT03950739results2024-11-01Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 3Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Completed | Drug: Treprostinil Inhalation Powder | Pulmonary Arterial Hypertension | 51 | 2023-08-22actual | — | 2024-11-01 |
| Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH SubjectsNCT04084678results2026-07-06Change From Baseline in Peak VO2 Assessed by CPETRandomized · Quadruple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor decision | Drug: Ralinepag, Placebo | Pulmonary Hypertension, Pulmonary Arterial Hypertension | 10 | 2023-04-12actual | — | 2026-07-06 |
| Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)NCT03794583results2023-12-18Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: Inhaled treprostinil solution | Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease | 41 | 2022-11-29actual | — | 2026-05-27 |
| A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)NCT03496623results2023-11-24Change From Baseline to Week 12 in 6-Minute Walk Distance (6MWD)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Sponsor's decision | Drug: Inhaled treprostinil solution, Placebo solution | Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease | 188 | 2022-10-13actual | — | 2023-11-24 |
| Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the NewbornNCT02261883results2024-03-05Number of Subjects Experiencing Clinical WorseningRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Terminatedsponsor's stated reason: Sponsor Decision | Drug: IV Remodulin, Placebo | Persistent Pulmonary Hypertension of the Newborn | 42 | 2022-09-27actual | — | 2024-03-05 |
| EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionNCT03497689results2023-08-07Number of Subjects Achieving Oral Treprostinil DoseOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Drug: Intravenous/Subcutaneous Treprostinil; Oral Treprostinil | Pulmonary Arterial Hypertension | 36 | 2022-05-11actual | — | 2023-08-07 |
| Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionNCT02999906Change in 6-Minute Walk Distance (6MWD)Randomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: For business reasons. | Drug: Oral Treprostinil, Placebo | Pulmonary Arterial Hypertension | 0 | Dec 2021 | — | 2017-11-01 |
| Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD)NCT03055234Effect of oral treprostinil compared with placebo on time to first adjudicated PH clinical worsening (morbidity or mortality) event in subjects with PH associated with SCDRandomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Business decision | Drug: Oral Treprostinil, Placebo | Pulmonary Hypertension Associated With Sickle Cell Disease | 0 | Dec 2021 | — | 2017-04-11 |
| An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionNCT01560637results2022-06-02Number of Adverse EventsOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Phase 3 | Completed | Drug: UT-15C (treprostinil diolamine) | Pulmonary Arterial Hypertension | 471 | 2021-08-12actual | — | 2022-06-02 |
| An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFENCT02633293results2022-12-02Change in Peak 6-Minute Walk Distance (6MWD) From BaselineOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Terminatedsponsor's stated reason: Inhaled treprostinil became commercially available in the US following its approval for PH-ILD | Drug: Inhaled Treprostinil | Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema | 243 | 2021-08-01actual | — | 2022-12-02 |
| An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionNCT02882126Incidence of Adverse Events Among Subjects through Study CompletionOpen-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Business decision | Drug: Subcutaneous Treprostinil | Pulmonary Arterial Hypertension | 0 | Jun 2021 | — | 2017-05-09 |
| A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPDNCT03857841results2021-10-12Number of Subjects With Treatment-emergent Adverse Events During the Post-treatment Phase (Safety and Tolerability)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 1 | Terminatedsponsor's stated reason: The study was discontinued due to a business decision; no safety concerns were noted. | Biological: UNEX-42, Phosphate-buffered saline | Bronchopulmonary Dysplasia | 3 | 2021-05-20actual | — | 2021-10-12 |
| Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial HypertensionNCT02279745results2021-12-22Change From Baseline in Pulmonary Vascular ResistanceOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Ralinepag | Pulmonary Arterial Hypertension | 45 | 2021-03-29actual | — | 2021-12-22 |
| Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEFNCT03043651results2020-10-22Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Terminated by Sponsor | Drug: Oral treprostinil | Pulmonary Hypertension Associated With HFpEF | 48 | 2020-03-02actual | — | 2020-10-22 |
| An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial HypertensionNCT01027949results2021-05-10Change in Exercise Capacity at Month 12Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Oral Treprostinil | Pulmonary Arterial Hypertension | 894 | 2020-02-12actual | — | 2021-05-10 |
| Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung CancerNCT03098030results2020-12-09Overall Survival (OS)Randomized · Open-label · TreatmentStatistical Analysis Plan ↗ · Study Protocol ↗ | Phase 2/3 | Completed | Biological: Dinutuximab · Drug: Irinotecan, Topotecan | Small Cell Lung Cancer | 483 | 2020-01-27actual | — | 2020-12-09 |
| Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFENCT02630316results2021-07-13Change in 6-minute Walk Distance (6MWD) Measured at Peak Exposure From Baseline to Week 16Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2/3 | Completed | Drug: Inhaled Treprostinil, Placebo | Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema | 326 | 2019-12-26actual | — | 2022-07-27 |
| Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection FractionNCT03037580results2020-10-22Change in 6MWD From Baseline to Week 24Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: Terminated by sponsor | Drug: Oral treprostinil, Placebo | Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction | 84 | 2019-12-03actual | — | 2020-11-10 |
| Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAHNCT03888365results2021-03-16observationalChange From Baseline in Patient Global Impression of Severity (PGI-S) Score in Cohort A Participants at Approximately 30 Minutes of Previous Dose of Inhaled Treprostinil (the Expected Peak Level) on Day 1Study Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | Drug: Treprostinil, Non-Treprostinil PAH Medications | Pulmonary Arterial Hypertension | 43 | 2019-09-19actual | — | 2021-03-16 |
| Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPDNCT03012646Incidence of Adverse Events Among Participants through 48 WeeksOpen-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Business decision | Drug: Inhaled Treprostinil | Pulmonary Hypertension, Chronic Obstructive Pulmonary Disease | 0 | Apr 2019 | — | 2017-04-11 |
| Inhaled Treprostinil for PAH: Open-label ExtensionNCT01557660Long term safety of inhaled treprostinilOpen-label · Treatment | Phase 3 | Withdrawn | Drug: inhaled treprostinil | Pulmonary Arterial Hypertension | 0 | Dec 2018 | — | 2012-03-26 |
| Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHNCT03016468Incidence of Adverse Events (AEs) through 16 WeeksOpen-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Business decision | Drug: Parenteral Remodulin (treprostinil) injection, Oral Treprostinil | Pulmonary Arterial Hypertension | 0 | Sep 2018 | — | 2017-04-11 |
| Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral MonotherapyNCT01560624results2020-02-13Time to First Clinical Worsening EventRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Treprostinil Diolamine, Placebo | Pulmonary Arterial Hypertension | 690 | 2018-06-24actual | — | 2020-02-13 |
| Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary FibrosisNCT02603068Change in pulmonary vascular resistance (PVR)Randomized · Open-label · Treatment | Phase 2 | Withdrawnsponsor's stated reason: Study design was inadequate and would not achieve study endpoints | Drug: Oral treprostinil | Pulmonary Hypertension, Pulmonary Fibrosis | 0 | Apr 2018 | — | 2016-02-09 |
| Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionNCT02893995Incidence of Adverse Events Among Subjects through 16 WeeksRandomized · Open-label · Treatment | Phase 4 | Withdrawnsponsor's stated reason: Business decision | Drug: Slow Dose Titration Group of Subcutaneous Treprostinil, Rapid Dose Titration Group of Subcutaneous Treprostinil | Pulmonary Arterial Hypertension | 0 | Apr 2018 | — | 2017-05-09 |
| Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 YearsNCT02276872results2019-01-04Number of Participants With Successful Transition From IV/SC Remodulin to Oral Treprostinil (Cohort 1), From Inhaled Prostacyclin to Oral Treprostinil (Cohort 2), or as an add-on to Current PAH Therapy in de Novo Prostacyclin Subjects (Cohort 3).Non-randomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: oral treprostinil | PAH | 32 | 2017-07-20actual | — | 2025-03-30 |
| Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionNCT02279160results2020-07-14Change From Baseline in Pulmonary Vascular Resistance (PVR)Randomized · Triple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: APD811, Placebo | Pulmonary Arterial Hypertension | 61 | Jun 2017actual | — | 2020-07-14 |
| Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma PatientsNCT02693171results2019-08-05observationalTo Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy. | — | Terminatedsponsor's stated reason: Sponsor decision | Drug: Dinutuximab | Neuroblastoma | 13 | 2016-12-19actual | — | 2019-08-05 |
| Safety and Efficacy of Inhaled Treprostinil in Patients With PAHNCT01557647Six-minute walk testRandomized · Quadruple-masked · Treatment | Phase 3 | Withdrawn | Drug: Inhaled treprostinil, Placebo | Pulmonary Arterial Hypertension | 0 | Dec 2015 | — | 2012-03-26 |
| Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH)NCT01795950Incidence of treatment-emergent AEs (frequency and severity at each dose level)Non-randomized · Open-label · Treatment | Phase 1 | Terminated | Drug: PLX-PAD | Pulmonary Arterial Hypertension | 6 | Dec 2015actual | — | 2016-02-17 |
| Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesNCT01266265results2016-02-17observationalPrevalence of Respiratory Tract-Related Adverse Events of Interest | — | Completed | Drug: inhaled prostacyclin, inhaled prostacyclin, prostacyclin, subcutaneous and intravenous prostacyclin, oral ERA, oral PDE5 inhibitors | Pulmonary Arterial Hypertension | 1,333 | Dec 2014actual | — | 2016-02-17 |
| Tyvaso Dosing and Titration Evaluation: TyTRATE RegistryNCT01799473observationalObserve dose changes of Tyvaso over time | — | Completed | — | Pulmonary Arterial Hypertension | 98 | Dec 2014actual | — | 2015-03-24 |
| Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male VolunteersNCT02149095Incidence of treatment-emergent AEsOpen-label · Treatment | Phase 1 | Withdrawnsponsor's stated reason: Study will not be conducted | Drug: TransCon PEG treprostinil | PAH | 0 | Nov 2014 | — | 2014-08-07 |
| Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy VolunteersNCT02318758Pharmacokinetics (PK) of oral treprostinil (Cmax)Randomized · Open-label | Phase 1 | Completed | Drug: UT-15C · Other: ethanol | Healthy | 32 | Oct 2014actual | — | 2015-03-24 |
| Remodulin® to Oral Treprostinil TransitionNCT01588405results2016-05-16Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.Open-label · Treatment | Phase 2 | Completed | Drug: UT-15C SR | Pulmonary Arterial Hypertension | 33 | Jul 2014actual | — | 2016-05-16 |
| ch14.18 Pharmacokinetic Study in High-risk NeuroblastomaNCT01592045results2015-09-23Area Under the Plasma Concentration Curve (AUC)Randomized · Open-label · Treatment | Phase 1/2 | Completed | Biological: ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), Aldesleukin (IL-2) · Drug: Isotretinoin | Neuroblastoma | 28 | Jun 2014actual | — | 2015-09-23 |
| Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)NCT02847260results2017-09-08Number of Participants With Successful Completion of the 16 Week Treatment Period.Open-label · Treatment | Phase 4 | Completed | Drug: Remodulin | Pulmonary Arterial Hypertension | 39 | Mar 2014actual | — | 2017-10-17 |
| TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)NCT03055221results2017-07-28Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)Open-label · Treatment | Phase 4 | Completed | Drug: Intravenous Treprostinil | Pulmonary Arterial Hypertension | 20 | 2014-02-25actual | — | 2024-01-05 |
| Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®NCT01477333results2017-03-06Change in Hemodynamic Parameters From Baseline to Week 24.Open-label · Treatment | Phase 2 | Completed | Drug: UT-15C SR, Tyvaso Inhalation Solution | Pulmonary Arterial Hypertension | 18 | Nov 2013actual | — | 2023-12-27 |
| A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolNCT01934582results2016-10-27To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).Open-label · Other | Phase 3 | Completed | Drug: UT-15C SR, treprostinil diethanolamine | Pulmonary Arterial Hypertension | 13 | Nov 2013actual | — | 2024-01-03 |
| A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionNCT01028651results2017-02-24observationalNumber of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | — | Completed | Drug: Treprostinil | Portopulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension | 13 | Apr 2013actual | — | 2017-02-24 |
| A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary HypertensionNCT01104870results2015-12-30Change in Peak Total Pulmonary Resistance Index (TPRI) During Exercise From Baseline to Week 12Randomized · Single-masked · Treatment | Phase 2 | Completed | Drug: UT-15C | Pulmonary Hypertension | 50 | Jan 2013actual | — | 2016-05-27 |
| Three Times Daily Dosing of UT-15CNCT01746485Area under the curve (AUC) from 0-24hrs after 6 days of TID dosing.Open-label | Phase 1 | Completed | Drug: UT-15C | Healthy | 19 | Jul 2012actual | — | 2012-12-12 |
| Open-Label Study of Oral Treprostinil in Digital UlcersNCT00848107results2014-02-07Net Ulcer Burden- Mean Change From Time of Study Entry for Each Scheduled Visit AssessmentOpen-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: The TDE-DU-202 extension study was discontinued after the randomized, placebo-controlled TDE-DU-201 study did not meet its primary efficacy objective. | Drug: treprostinil diethanolamine | Systemic Sclerosis | 115 | Sep 2011actual | — | 2024-06-18 |
| Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionNCT00887978results2013-01-156-minute Walk Distance (6MWD)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: UT-15C SR, Placebo | Pulmonary Hypertension | 310 | Jul 2011actual | — | 2013-01-15 |
| FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)NCT00325403results2013-03-18Six Minute Walk Distance (6MWD)Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Oral treprostinil (UT-15C) Sustained Release Tablets · Other: Placebo | Pulmonary Hypertension | 349 | Apr 2011actual | — | 2024-01-03 |
| Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil DiethanolamineNCT00775463results2014-03-17Net Ulcer BurdenRandomized · Double-masked · Treatment | Phase 2 | Completed | Drug: treprostinil diethanolamine, placebo | Systemic Sclerosis, Scleroderma | 148 | Mar 2011actual | — | 2023-12-28 |
| The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilNCT01131845Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: UT-15C SR (treprostinil diethanolamine) | Pulmonary Arterial Hypertension, Renal Dysfunction | 16 | Sep 2010actual | — | 2012-05-17 |
| A Study of MAb-3F8 Plus Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Versus 13-cis-Retinoic Acid (RA) Plus GM-CSF in Primary Refractory Neuroblastoma PatientsNCT00969722To compare the proportion of patients achieving a complete bone marrow response measured by an absence of histological evidence of bone marrow disease and by MIBG scan after two cycles of treatment.Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Lack of enrollment. | Biological: MAb-3F8, Subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), 13-cis-Retinoic Acid | Primary Refractory Neuroblastoma | 1 | Aug 2010actual | — | 2013-03-08 |
| Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil DiethanolamineNCT01153386Treprostinil pharmacokineticsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Treprostinil diethanolamine | Pulmonary Arterial Hypertension | 36 | Aug 2010actual | — | 2010-08-23 |
| Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent FacilitiesNCT01165476Treprostinil pharmacokineticsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Treprostinil diethanolamine | Pulmonary Arterial Hypertension | 64 | Aug 2010actual | — | 2011-04-19 |
| A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy VolunteersNCT01172496Plasma treprostinil concentrationsRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: treprostinil diethanolamine | Pulmonary Arterial Hypertension | 24 | Aug 2010actual | — | 2010-10-13 |
| Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant RecipientsNCT01884038Duration of the initial hospitalization (days) following transplantationRandomized · Quadruple-masked · Prevention | Phase 2/3 | Withdrawn | Drug: treprostinil sodium, Placebo | Liver Transplant | 0 | Jun 2010 | — | 2023-12-19 |
| Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsNCT00741819results2013-02-20Number of Adverse EventsNon-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: Inhaled treprostinil | Pulmonary Arterial Hypertension | 73 | Mar 2010actual | — | 2013-02-20 |
| Rapid Switch From Flolan to Remodulin in the Outpatient ClinicNCT00643604results2013-06-21Change in Six Minute Walk DistanceNon-randomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Due to availability of eligible subjects at center and enrollment competition with other studies. | Drug: treprostinil sodium | Hypertension, Pulmonary | 7 | Jan 2010actual | — | 2024-01-03 |
| Pharmacokinetics of Oral Treprostinil in Patients With Systemic SclerosisNCT00848939Cohort 1: treprostinil pharmacokinetics in patients with systemic sclerosis following single oral administration of a 1 mg treprostinil diethanolamine SR dose.Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: treprostinil diethanolamine, treprostinil diethanolamine | Systemic Sclerosis | 28 | Jan 2010actual | — | 2012-10-23 |
| Effect of Food on the Pharmacokinetics of Oral TreprostinilNCT00963001Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet after four different meal types.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Treprostinil diethanolamine · Other: Standardized meals | Hypertension, Pulmonary, Pulmonary Arterial Hypertension | 32 | Nov 2009actual | — | 2010-03-08 |
| Effect of Esomeprazole on the Pharmacokinetics of Oral TreprostinilNCT00963027Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet before and after repeated dosing with esomeprazole.Open-label · Treatment | Phase 1 | Completed | Drug: Treprostinil diethanolamine, Esomeprazole | Hypertension, Pulmonary, Pulmonary Arterial Hypertension | 30 | Oct 2009actual | — | 2010-03-08 |
| Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHNCT00439946results2013-07-17Change From Baseline at Week 8 in 6-Minute Walk Distance (6MWD)Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Study closed due to limited availability of eligible subjects and competition by for enrollment by other studies | Drug: treprostinil · Device: Crono Five ambulatory pump | Pulmonary Arterial Hypertension | 8 | Sep 2009actual | — | 2024-01-03 |
| FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)NCT00760916Change in six-minute walk distance from Baseline to Week 12Randomized · Quadruple-masked · Treatment | Phase 3 | Withdrawnsponsor's stated reason: Study stopped prior to subject enrollment. | Drug: UT-15C 1 mg, UT-15C 0.25 mg, UT-15C 5 mg, Placebo | Pulmonary Hypertension | 0 | Jan 2009actual | — | 2013-01-30 |
| 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)NCT00325442results2013-06-10Six Minute Walk Distance (6MWD)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Oral treprostinil (UT-15C) sustained release tablets, Placebo | Pulmonary Hypertension | 354 | Sep 2008actual | — | 2017-08-02 |
| Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to RemodulinNCT00373360results2013-01-07Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8.Non-randomized · Open-label · Treatment | Phase 4 | Completed | Drug: treprostinil sodium | Pulmonary Hypertension | 10 | Jan 2008actual | — | 2013-01-07 |
| Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)NCT00147199results2013-08-12Peak 6-minute Walk DistanceRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Inhaled treprostinil, Placebo inhalation solution | Pulmonary Hypertension | 235 | Oct 2007actual | — | 2024-01-02 |
| Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial HypertensionNCT00494533Six-minute walk distanceRandomized · Quadruple-masked · Treatment | Phase 4 | Terminatedsponsor's stated reason: Safety issues related to outpatient intravenous infusion in India | Drug: Remodulin (treprostinil sodium) | Pulmonary Arterial Hypertension | 45 | Oct 2005actual | — | 2014-01-29 |
| A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial HypertensionNCT00058929Randomized · Double-masked · Treatment | Phase 4 | Completed | Drug: treprostinil sodium | Pulmonary Arterial Hypertension, Pulmonary Hypertension | 39 | Aug 2005actual | — | 2013-03-07 |
| Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization ProceduresNCT00060996Randomized · Double-masked · Treatment | Phase 3 | Terminated | Drug: Remodulin® (treprostinil sodium) Injection | Critical Limb Ischemia, Peripheral Vascular Disease, Foot Ulcers, Rest Leg Pain | 30 | Sep 2004actual | — | 2013-03-07 |
| Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass GraftNCT00067041Randomized · Double-masked · Treatment | Phase 2/3 | Terminated | Drug: Remodulin (treprostinil sodium) Injection | Peripheral Vascular Disease | 30 | Dec 2003actual | — | 2013-03-07 |
| Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary HypertensionNCT00004497Randomized · Double-masked · Treatment | Phase 3 | Completed | Drug: UT-15 | Pulmonary Hypertension | — | — | — | 2015-03-25 |
| 12 Week Study of Anti-Viral Effect of Oral UT-231B in Non-cirrhotic Hepatitis C Patients who have Failed Interferon-based Therapy.NCT00069511Randomized · Double-masked · Treatment | Phase 2 | Unknown status | Drug: UT-231B | Hepatitis C | 72 | — | — | 2005-06-24 |
| Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment SatisfactionNCT00458042Primary Outcomes: Change in distance traversed during the six minute walk test at 8 weeks;Non-randomized · Open-label · Treatment | Phase 4 | Terminatedsponsor's stated reason: Low Enrollment | Drug: treprostinil sodium | Hypertension, Pulmonary | 10 | — | — | 2007-11-12 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19