COMPANY

United Therapeutics

HQ: Silver Spring, MD source · unither.com ↗

FDA-cleared device company Clinical Phase 3

Location: Silver Spring, MD · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: PAH Pulmonary Hypertension Pulmonary Arterial Hypertension Idiopathic Pulmonary Fibrosis Interstitial Lung Disease Chronic Obstructive Pulmonary Disease Hypertension Connective Tissue Diseases Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Disease Progressive Pulmonary Fibrosis ESRD (End-Stage Renal Disease) Kidney Transplantation Xenotransplantation Systemic Sclerosis Combined Pulmonary Fibrosis and Emphysema Pulmonary Hypertension Due to Lung Diseases and Hypoxia Persistent Pulmonary Hypertension of the Newborn Scleroderma Liver Transplant Bronchopulmonary Dysplasia Small Cell Lung Cancer Heart Failure With Preserved Ejection Fraction Pulmonary Hypertension Associated With HFpEF Neuroblastoma Pulmonary Hypertension Associated With Sickle Cell Disease Ralinepag treprostinil diethanolamine treprostinil GGTA1 KO Thymokidney 10 GE Xenokidney Remunity Pump for Remodulin

83Trials (company is sponsor)

Timeline

2026-11 Trial start Phase 1/Phase 2: Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD source ↗
Oct 29, 2025 Trial start Phase 1/Phase 2: Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD source ↗
Jan 23, 2025 Trial start —: DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) source ↗
Oct 30, 2023 Trial start Phase 3: Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF) source ↗
Aug 11, 2023 Trial start —: Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection source ↗
Jul 5, 2023 Trial start —: Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin source ↗
Oct 20, 2022 Trial start Phase 4: 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 Hyperte source ↗
Oct 4, 2022 Trial start Phase 3: Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis source ↗
Sep 6, 2022 Trial start Phase 3: Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease source ↗
Jun 1, 2021 Trial start Phase 3: Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis source ↗
Jan 20, 2021 Trial start Phase 3: Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects source ↗
Oct 9, 2019 Trial start Phase 1: A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD source ↗
Sep 23, 2019 Trial start Phase 3: A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension source ↗
Sep 17, 2019 Trial start Phase 1: Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso source ↗
Apr 1, 2019 Trial start —: Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH source ↗
Jan 31, 2019 Trial start Phase 4: EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension source ↗
Jan 24, 2019 Trial start Phase 3: A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients source ↗
Dec 21, 2018 Trial start Phase 3: Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD) source ↗
May 8, 2018 Trial start 3: 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) source ↗
Jan 30, 2018 Trial start Phase 3: Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF source ↗
2017-10 Trial start Phase 3: Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension source ↗
Aug 15, 2017 Trial start Phase 3: Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction source ↗
Jul 18, 2017 Trial start —: ADAPT - A Patient Registry of the Real-world Use of Orenitram® source ↗
Jun 1, 2017 Trial start Phase 2/Phase 3: Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer source ↗
2017-06 Trial start Phase 4: An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension source ↗

Showing 25 of 50 dated events.

Upcoming milestones

2026-12 (ESTIMATED) · Phase 3 · A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension · NCT03683186
2027-03 (ESTIMATED) · · ADAPT - A Patient Registry of the Real-world Use of Orenitram® · NCT03045029
2027-11 (ESTIMATED) · Phase 3 · Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF) · NCT05943535
2028-10 (ESTIMATED) · Phase 1/Phase 2 · Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD · NCT06878560
2029-11 (ESTIMATED) · Phase 1/Phase 2 · Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD · NCT07224763
2029-12 (ESTIMATED) · Phase 3 · Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease · NCT04905693
Sep 1, 2030 (ESTIMATED) · · DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) · NCT06388421

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 83

Record	Title	Phase	Status	Start	Primary completion
NCT03683186	A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3	Enrolling by invitation	Sep 23, 2019	2026-12 (estimated)
NCT04905693	Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease	Phase 3	Enrolling by invitation	Sep 6, 2022	2029-12 (estimated)
NCT07224763	Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD	Phase 1/Phase 2	Recruiting	2026-11	2029-11 (estimated)
NCT06388421	DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)	Not listed	Recruiting	Jan 23, 2025	Sep 1, 2030 (estimated)
NCT05943535	Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)	Phase 3	Recruiting	Oct 30, 2023	2027-11 (estimated)
NCT04084678	Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects	Phase 3	Terminated	Jan 20, 2021	Apr 12, 2023 (actual)
NCT03626688	A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients	Phase 3	Completed	Jan 24, 2019	Dec 31, 2025 (actual)
NCT05776225	Pulmonary Hypertension Screening in Patients With Interstitial Lung Disease for Earlier Detection	Not listed	Completed	Aug 11, 2023	Mar 13, 2026 (actual)
NCT03794583	Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)	Phase 3	Terminated	Dec 21, 2018	Nov 29, 2022 (actual)
NCT04708782	Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3	Completed	Jun 1, 2021	Feb 2, 2026 (actual)
NCT03045029	ADAPT - A Patient Registry of the Real-world Use of Orenitram®	Not listed	Active, not recruiting	Jul 18, 2017	2027-03 (estimated)
NCT06878560	Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD	Phase 1/Phase 2	Recruiting	Oct 29, 2025	2028-10 (estimated)
NCT05203510	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 Hypertension	Phase 4	Active, not recruiting	Oct 20, 2022	Apr 30, 2026 (estimated)
NCT05255991	Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis	Phase 3	Completed	Oct 4, 2022	Jun 30, 2025 (actual)
NCT02276872	Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years	Phase 2	Completed	Dec 18, 2014	Jul 20, 2017 (actual)
NCT05060315	Evaluate Real-World Use of Next Generation Infusion Pumps to Administer Remodulin	Not listed	Terminated	Jul 5, 2023	Dec 31, 2024 (actual)
NCT03950739	Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso	Phase 1	Completed	Sep 17, 2019	Aug 22, 2023 (actual)
NCT00848107	Open-Label Study of Oral Treprostinil in Digital Ulcers	Phase 2	Terminated	2009-09	2011-09 (actual)
NCT02261883	Remodulin as Add-on Therapy for the Treatment of Persistent Pulmonary Hypertension of the Newborn	Phase 2	Terminated	Jul 29, 2015	Sep 27, 2022 (actual)
NCT03055221	TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)	Phase 4	Completed	Jun 10, 2005	Feb 25, 2014 (actual)
NCT00643604	Rapid Switch From Flolan to Remodulin in the Outpatient Clinic	Phase 4	Terminated	2008-03	2010-01 (actual)
NCT01934582	A Pharmacokinetic Substudy of the TDE-PH-304 Protocol	Phase 3	Completed	2013-08	2013-11 (actual)
NCT00439946	Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH	Phase 4	Terminated	2007-02	2009-09 (actual)
NCT00325403	FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)	Phase 3	Completed	2006-10	2011-04 (actual)
NCT00147199	Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)	Phase 3	Completed	2005-06	2007-10 (actual)
NCT00775463	Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine	Phase 2	Completed	2009-05	2011-03 (actual)
NCT01477333	Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®	Phase 2	Completed	2011-10	2013-11 (actual)
NCT01884038	Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients	Phase 2/Phase 3	Withdrawn	2008-06	2010-06 (estimated)
NCT03496623	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)	3	Terminated	May 8, 2018	Oct 13, 2022 (actual)
NCT03497689	EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension	Phase 4	Completed	Jan 31, 2019	May 11, 2022 (actual)
NCT02633293	An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE	Phase 2/Phase 3	Terminated	Sep 15, 2016	Aug 1, 2021 (actual)
NCT02630316	Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE	Phase 2/Phase 3	Completed	Feb 3, 2017	Dec 26, 2019 (actual)
NCT01560637	An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension	Phase 3	Completed	Sep 11, 2013	Aug 12, 2021 (actual)
NCT02279745	Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension	Phase 2	Completed	Jul 8, 2015	Mar 29, 2021 (actual)
NCT03857841	A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD	Phase 1	Terminated	Oct 9, 2019	May 20, 2021 (actual)
NCT01027949	An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension	Phase 3	Completed	Jan 16, 2007	Feb 12, 2020 (actual)
NCT03888365	Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH	Not listed	Completed	Apr 1, 2019	Sep 19, 2019 (actual)
NCT03098030	Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer	Phase 2/Phase 3	Completed	Jun 1, 2017	Jan 27, 2020 (actual)
NCT03037580	Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction	Phase 3	Terminated	Aug 15, 2017	Dec 3, 2019 (actual)
NCT03043651	Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF	Phase 3	Terminated	Jan 30, 2018	Mar 2, 2020 (actual)
NCT02279160	Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension	Phase 2	Completed	2014-12	2017-06 (actual)
NCT01560624	Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy	III	Completed	Jun 26, 2012	Jun 24, 2018 (actual)
NCT02693171	Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients	Not listed	Terminated	Mar 15, 2016	Dec 19, 2016 (actual)
NCT02999906	Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension	Phase 3	Withdrawn	2017-10	2021-12 (estimated)
NCT02847260	Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)	Phase 4	Completed	2012-04	2014-03 (actual)
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)	Phase 3	Completed	2006-10	2008-09 (actual)
NCT02893995	Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension	Phase 4	Withdrawn	2017-02	2018-04 (estimated)
NCT02882126	An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension	Phase 4	Withdrawn	2017-06	2021-06 (estimated)
NCT03012646	Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD	Phase 2	Withdrawn	2017-04	2019-04 (estimated)
NCT03055234	Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD)	Phase 3	Withdrawn	2017-06	2021-12 (estimated)