Treprostinil sodium Clinical Trials

Size	Price	Qty
5mg	USD 277
25mg	USD 977

Clinical Trials

Numerous clinical trials evaluate treprostinil sodium across severe pulmonary vascular disorders—including pulmonary arterial hypertension, interstitial lung disease-associated pulmonary hypertension, non-operable chronic thromboembolic pulmonary hypertension, and pulmonary hypertension due to left heart disease—as well as in healthy volunteers. Spanning Phase 1 safety evaluations to Phase 4 studies, including Phase 2/3 extension and Phase 3 efficacy trials, these investigations exhibit statuses ranging from active and recruiting to completed, terminated, and withdrawn. Research is supported by academic medical institutions alongside major industry sponsors, including United Therapeutics, Insmed Incorporated, and SciPharm SàRL.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07234032	RECRUITING	Pulmonary Hypertension; Interstitial Lung Disease	Insmed Incorporated	2026-07-20	PHASE3
NCT07805785	NOT_YET_RECRUITING	Progressive Pulmonary Fibrosis; Interstitial Lung Disease	Insmed Incorporated	2026-12-01	PHASE3
NCT04905693	ENROLLING_BY_INVITATION	Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease; Progressive Pulmonary Fibrosis	United Therapeutics	2022-09-06	PHASE3
NCT07285655	RECRUITING	Pulmonary Hypertension Due to Lung Disease (Disorder)	Liquidia Technologies, Inc.	2026-04-23	PHASE3
NCT07179380	RECRUITING	Pulmonary Hypertension; Interstitial Lung Disease	Insmed Incorporated	2026-01-07	PHASE3
NCT07481981	RECRUITING	Pulmonary Arterial Hypertension	Insmed Incorporated	2026-07-21	PHASE3
NCT06350032	RECRUITING	Pulmonary Arterial Hypertension	AOP Orphan Pharmaceuticals AG	2024-07-31	PHASE3
NCT07112183	RECRUITING	Raynaud's Disease; Raynaud Phenomena; Raynauds	Brigham and Women's Hospital	2025-10-15	PHASE4
NCT04005469	RECRUITING	Ischemia Reperfusion Injury; Delayed Graft Function	Rhode Island Hospital	2020-11-13	PHASE1; PHASE2
NCT07177703	NOT_YET_RECRUITING	Pulmonary Arterial Hypertension (PAH)	Shanghai Zhongshan Hospital	2025-10-31	PHASE2
NCT05943535	RECRUITING	Progressive Pulmonary Fibrosis; Interstitial Lung Disease	United Therapeutics	2023-10-30	PHASE3
NCT07116681	NOT_YET_RECRUITING	Pulmonary Hypertension	University of California, San Diego	2025-10-01	EARLY_PHASE1
NCT07037836	RECRUITING	COPD (Chronic Obstructive Pulmonary Disease); Hypoxemia	Bastiaan Driehuys	2025-09-29	PHASE2
NCT06317805	RECRUITING	Pulmonary Arterial Hypertension	AOP Orphan Pharmaceuticals AG	2023-12-06	PHASE4
NCT07759804	NOT_YET_RECRUITING	Pulmonary Arterial Hypertension (PAH)	Liquidia Technologies, Inc.	2026-09	PHASE4
NCT07643155	RECRUITING	Hepatic Impairment	Insmed Incorporated	2026-07-14	PHASE1
NCT07748000	NOT_YET_RECRUITING	Raynaud's Phenomenon Secondary to Systemic Sclerosis	Liquidia Technologies, Inc.	2026-10-26	PHASE2
NCT05649748	ACTIVE_NOT_RECRUITING	Pulmonary Arterial Hypertension	Insmed Incorporated	2023-03-07	PHASE2; PHASE3
NCT06969573	ACTIVE_NOT_RECRUITING	COPD (Chronic Obstructive Pulmonary Disease)	University of Alberta	2025-06-05	PHASE2
NCT07333183	RECRUITING	Pulmonary Hypertension; Interstitial Lung Disease (ILD); Lung Diseases; Vascular Diseases; Cardiovascular Diseases; Fibrosis	Pulmovant, Inc.	2025-12-23	PHASE2
NCT05203510	ACTIVE_NOT_RECRUITING	Pulmonary Arterial Hypertension	United Therapeutics	2022-10-20	PHASE4
NCT05649722	COMPLETED	Pulmonary Hypertension; Interstitial Lung Disease	Insmed Incorporated	2023-05-11	PHASE2; PHASE3
NCT04708782	COMPLETED	Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease	United Therapeutics	2021-06-01	PHASE3
NCT04062565	RECRUITING	Pulmonary Arterial Hypertension	University of Arizona	2019-03-25	PHASE3
NCT03814317	COMPLETED	Sarcoidosis; Precapillary Pulmonary Hypertension; Interstitial Lung Disease	University of Florida	2020-01-30	PHASE2
NCT05255991	COMPLETED	Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease	United Therapeutics	2022-10-04	PHASE3
NCT03835676	UNKNOWN	Pulmonary Hypertension	Magdi H. Yacoub	2019-05-01	PHASE4
NCT03992755	ACTIVE_NOT_RECRUITING	Primary Pulmonary Hypertension	Liquidia Technologies, Inc.	2019-07-18	PHASE3
NCT04882774	WITHDRAWN	Pulmonary Hypertension Due to Left Heart Disease	Mardi Gomberg -Maitland MD, MSc	2023-04	PHASE2
NCT05147805	COMPLETED	Pulmonary Arterial Hypertension	Insmed Incorporated	2022-08-24	PHASE2
NCT04691154	ACTIVE_NOT_RECRUITING	Pulmonary Arterial Hypertension; Pulmonary Hypertension Due to Lung Diseases	Liquidia Technologies, Inc.	2021-08-01	PHASE3
NCT05564637	COMPLETED	Pulmonary Arterial Hypertension; Interstitial Lung Disease; Healthy Adults	Mayo Clinic	2023-03-13	PHASE2
NCT06605326	COMPLETED	Pulmonary Hypertension; Pulmonary Arterial Hypertension; Chronic Lung Disease-Associated Pulmonary Hypertension; Lung Transplantation; Heart Failure	Guangzhou Institute of Respiratory Disease	2015-01-01	PHASE4
NCT05176951	COMPLETED	Pulmonary Hypertension	Insmed Incorporated	2022-12-22	PHASE2
NCT03950739	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2019-09-17	PHASE1
NCT05060315	Active not recruiting	Pulmonary Arterial Hypertension	United Therapeutics	2023-07-05	--
NCT05649722	Recruiting	Pulmonary Hypertension\|Interstitial Lung Disease	Insmed Incorporated	2023-05-11	Phase 2\|Phase 3
NCT04882774	Withdrawn	Pulmonary Hypertension Due to Left Heart Disease	Mardi Gomberg -Maitland MD MSc\|Ohio State University\|Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)\|George Washington University	2023-04	Phase 2
NCT05649748	Recruiting	Pulmonary Arterial Hypertension	Insmed Incorporated	2023-03-07	Phase 2\|Phase 3
NCT05176951	Completed	Pulmonary Hypertension	Insmed Incorporated	2022-12-22	Phase 2
NCT03794583	TERMINATED	Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease	United Therapeutics	2018-12-21	PHASE3
NCT03496623	TERMINATED	Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease	United Therapeutics	2018-05-08	PHASE3
NCT02261883	TERMINATED	Persistent Pulmonary Hypertension of the Newborn	United Therapeutics	2015-07-29	PHASE2
NCT04791514	TERMINATED	Pulmonary Arterial Hypertension	Insmed Incorporated	2022-03-29	PHASE2
NCT03497689	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2019-01-31	PHASE4
NCT02583789	COMPLETED	Raynaud's Phenomenon	Brigham and Women's Hospital	2016-05	EARLY_PHASE1
NCT03654989	TERMINATED	Diabetic Foot Ulcer	University Hospital, Grenoble	2020-01-28	PHASE1; PHASE2
NCT05067270	COMPLETED	Type 1 Diabetes Mellitus	Eli Lilly and Company	2021-10-22	PHASE1
NCT02999906	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2017-10	PHASE3
NCT03055234	WITHDRAWN	Pulmonary Hypertension Associated With Sickle Cell Disease	United Therapeutics	2017-06	PHASE3
NCT01560637	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2013-09-11	PHASE3
NCT02633293	TERMINATED	Pulmonary Hypertension; Interstitial Lung Disease; Combined Pulmonary Fibrosis and Emphysema	United Therapeutics	2016-09-15	PHASE2; PHASE3
NCT02882126	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2017-06	PHASE4
NCT06091579	COMPLETED	Healthy Volunteers	Insmed Incorporated	2020-09-17	PHASE1
NCT03884465	TERMINATED	Pulmonary Arterial Hypertension	Liquidia Technologies, Inc.	2019-11-11	PHASE2
NCT02498444	TERMINATED	Single Ventricle	Stanford University	2015-09
NCT02663895	COMPLETED	Systemic Sclerosis; Calcinosis	Stanford University	2016-10	PHASE2
NCT03043651	TERMINATED	Pulmonary Hypertension Associated With HFpEF	United Therapeutics	2018-01-30	PHASE3
NCT01027949	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2007-01-16	PHASE3
NCT02630316	COMPLETED	Pulmonary Hypertension; Interstitial Lung Disease; Combined Pulmonary Fibrosis and Emphysema	United Therapeutics	2017-02-03	PHASE2; PHASE3
NCT03037580	TERMINATED	Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction	United Therapeutics	2017-08-15	PHASE3
NCT04041648	COMPLETED	Pulmonary Arterial Hypertension	Pharmosa Biopharm Inc.	2018-11-09	PHASE1
NCT03120533	COMPLETED	Scleroderma, Systemic	University Hospital, Grenoble	2017-06-20	PHASE1; PHASE2
NCT01481974	COMPLETED	Ischemia Reperfusion Injury	Abhinav Humar, MD	2012-12	PHASE1
NCT03399604	COMPLETED	Primary Pulmonary Hypertension	Liquidia Technologies, Inc.	2018-01-02	PHASE3
NCT03012646	WITHDRAWN	Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease	United Therapeutics	2017-04	PHASE2
NCT01615627	WITHDRAWN	Pulmonary Arterial Hypertension	Jewish General Hospital	2012-07-01	PHASE4
NCT01908699	COMPLETED	Pulmonary Arterial Hypertension	Lung Biotechnology PBC	2013-05-31	PHASE3
NCT02178566	TERMINATED	Chronic Obstructive Pulmonary Disease (COPD)	Inova Health Care Services	2015-08	PHASE2
NCT01557660	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2012-06	PHASE3
NCT02769624	TERMINATED	Congenital Heart Disease	Children's Hospital Medical Center, Cincinnati	2017-02-21	PHASE2
NCT03016468	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2017-05	PHASE2
NCT01560624	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2012-06-26	PHASE3
NCT03464864	COMPLETED	Pulmonary Arterial Hypertension	Mannkind Corporation	2018-03-09	PHASE1
NCT04675944	COMPLETED	Pulmonary Arterial Hypertension	Bial - Portela C S.A.	2018-02-28	PHASE1
NCT02893995	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2017-02	PHASE4
NCT02603068	WITHDRAWN	Pulmonary Hypertension; Pulmonary Fibrosis	United Therapeutics	2016-02	PHASE2
NCT02370095	TERMINATED	Respiratory Distress Syndrome, Adult	University of North Carolina, Chapel Hill	2015-02	PHASE2
NCT02276872	COMPLETED	PAH	United Therapeutics	2014-12-18	PHASE2
NCT02471183	COMPLETED	Pulmonary Arterial Hypertension	Actelion	2015-10-12	PHASE3
NCT01416636	COMPLETED	Non-operable Chronic Thromboembolic Pulmonary Hypertension	SciPharm SàRL	2009-03	PHASE3
NCT01268553	COMPLETED	Pulmonary Arterial Hypertension	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2010-08	PHASE4
NCT02770521	COMPLETED	Healthy	Eli Lilly and Company	2016-05	PHASE1
NCT01758744	COMPLETED	Pulmonary Hypertension; COPD	University of Colorado, Denver	2012-12	PHASE1
NCT01557647	WITHDRAWN	Pulmonary Arterial Hypertension	United Therapeutics	2012-06	PHASE3
NCT03803163	TERMINATED	Healthy Volunteers	Ascendis Pharma A/S	2015-01	PHASE1
NCT02149095	WITHDRAWN	PAH	United Therapeutics	2014-07	PHASE1
NCT02318758	COMPLETED	Healthy	United Therapeutics	2014-09	PHASE1
NCT01305252	COMPLETED	Hypertension, Pulmonary	Stanford University	2010-07	PHASE4
NCT01588405	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2012-04	PHASE2
NCT03055221	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2005-06-10	PHASE4
NCT01934582	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2013-08	PHASE3
NCT01554540	UNKNOWN	Scleroderma, Systemic	University Hospital, Grenoble	2012-02	PHASE1; PHASE2
NCT01104870	COMPLETED	Pulmonary Hypertension	United Therapeutics	2010-04	PHASE2
NCT01302444	TERMINATED	Pulmonary Arterial Hypertension	Rhode Island Hospital	2011-03	PHASE4
NCT01433328	TERMINATED	Pulmonary Arterial Hypertension	Jewish General Hospital	2012-01	PHASE4
NCT01260454	COMPLETED	Pulmonary Hypertension; Pulmonary Arterial Hypertension	University of Rochester	2010-11	PHASE2
NCT00848107	TERMINATED	Systemic Sclerosis	United Therapeutics	2009-09	PHASE2
NCT00325403	COMPLETED	Pulmonary Hypertension	United Therapeutics	2006-10	PHASE3
NCT00775463	COMPLETED	Systemic Sclerosis; Scleroderma	United Therapeutics	2009-05	PHASE2
NCT00705133	COMPLETED	Pulmonary Arterial Hypertension; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis	Rajan Saggar	2008-07	PHASE2
NCT01082484	COMPLETED	Healthy	University Hospital, Grenoble	2010-01	PHASE1; PHASE2
NCT00651885	COMPLETED	Critical Limb Ischemia	Ochsner Health System	2008-03	PHASE2
NCT01131845	COMPLETED	Pulmonary Arterial Hypertension; Renal Dysfunction	United Therapeutics	2010-05	PHASE1
NCT01153386	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2010-07	PHASE1
NCT01172496	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2010-08	PHASE1
NCT01165476	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2010-07	PHASE1
NCT01884038	WITHDRAWN	Liver Transplant	United Therapeutics	2008-06	PHASE2; PHASE3
NCT00741819	COMPLETED	Pulmonary Arterial Hypertension	United Therapeutics	2008-09	PHASE4
NCT00848939	COMPLETED	Systemic Sclerosis	United Therapeutics	2008-12	PHASE1
NCT00643604	TERMINATED	Hypertension, Pulmonary	United Therapeutics	2008-03	PHASE4
NCT00703339	TERMINATED	Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension	Lung Biotechnology PBC	2008-06	PHASE2
NCT00963001	COMPLETED	Hypertension, Pulmonary; Pulmonary Arterial Hypertension	United Therapeutics	2009-09	PHASE1
NCT00963027	COMPLETED	Hypertension, Pulmonary; Pulmonary Arterial Hypertension	United Therapeutics	2009-09	PHASE1
NCT00439946	TERMINATED	Pulmonary Arterial Hypertension	United Therapeutics	2007-02	PHASE4
NCT00325442	COMPLETED	Pulmonary Hypertension	United Therapeutics	2006-10	PHASE3
NCT00373360	COMPLETED	Pulmonary Hypertension	United Therapeutics	2006-09	PHASE4
NCT00147199	COMPLETED	Pulmonary Hypertension	United Therapeutics	2005-06	PHASE3
NCT00494533	TERMINATED	Pulmonary Arterial Hypertension	United Therapeutics	2005-03	PHASE4
NCT00058929	COMPLETED	Pulmonary Arterial Hypertension; Pulmonary Hypertension	United Therapeutics	2002-10	PHASE4
NCT00060996	TERMINATED	Critical Limb Ischemia; Peripheral Vascular Disease; Foot Ulcers; Rest Leg Pain	United Therapeutics	2003-02	PHASE3
NCT00067041	TERMINATED	Peripheral Vascular Disease	United Therapeutics	2003-03	PHASE2; PHASE3
NCT00445159	UNKNOWN	Critical Limb Ischemia	Southern Arizona Vascular Institute	2006-11	PHASE2
NCT00458042	TERMINATED	Hypertension, Pulmonary	United Therapeutics	2007-03	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-08-13)

Check the Treprostinil sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Treprostinil sodium functions as a potent agonist of DP1, EP2, and IP receptors with Ki values of 4.4 nM, 3.6 nM, and 32 nM, respectively, driving adenylate cyclase activation and elevating intracellular cyclic AMP levels. The resulting signaling cascade induces direct vasodilation of pulmonary vascular beds and suppresses smooth muscle cell proliferation, which provides the pharmacological mechanism for reducing pulmonary vascular resistance in patients evaluated for pulmonary arterial hypertension and related conditions.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).