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Treprostinil

Generic Name
Treprostinil
Brand Names
Orenitram, Remodulin, Tyvaso, Trepulmix
Drug Type
Small Molecule
Chemical Formula
C23H34O5
CAS Number
81846-19-7
Unique Ingredient Identifier
RUM6K67ESG
Background

Treprostinil is a stable tricyclic analogue of prostacyclin that promotes the vasodilation of pulmonary and systemic arterial vascular beds and the inhibition of platelet aggregation. It reduces symptoms in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease. The first agent approved for the treatment of PAH was epoprostenol, a synthetic prostacyclin that significantly increases patients' quality of life. However, the use of epoprostenol is limited due to its short half-life (3-5 min) and instability at room temperature. The use of more stable alternatives such as treprostinil provides patients with PAH with more treatment options.

Treprostinil was approved by the FDA in 2002 for the treatment of pulmonary arterial hypertension. It is available in the following routes of administration: subcutaneous, intravenous, inhaled and oral. The first generic form of treprostinil became available in 2019.

Indication

The FDA has indicated treprostinil for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to improve exercise ability. It is also used to treat pulmonary arterial hypertension in patients requiring transition from epoprostenol. The Health Canada label specifies that treprostinil is indicated for the long-term treatment of pulmonary arterial hypertension in NYHA Class III and IV patients who did not respond adequately to conventional therapy.

L24244

Associated Conditions
Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)

Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years

Phase 2
Completed
Conditions
PAH
Interventions
First Posted Date
2014-10-28
Last Posted Date
2025-03-30
Lead Sponsor
United Therapeutics
Target Recruit Count
32
Registration Number
NCT02276872
Locations
🇺🇸

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

🇺🇸

University of California San Francisco, San Francisco, California, United States

🇺🇸

Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

and more 6 locations

Pulmonary Rehab in Chronic Obstructive Pulmonary Disease (COPD): Response to Tyvaso

Phase 2
Terminated
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
First Posted Date
2014-07-01
Last Posted Date
2022-04-12
Lead Sponsor
Inova Health Care Services
Target Recruit Count
1
Registration Number
NCT02178566
Locations
🇺🇸

Inova Fairfax Medical Campus, Falls Church, Virginia, United States

Dose Escalation, MTD, Safety and PK Study of a Single Dose SC Injection of TransCon PEG Treprostinil in Healthy Male Volunteers

Phase 1
Withdrawn
Conditions
PAH
Interventions
First Posted Date
2014-05-29
Last Posted Date
2014-08-07
Lead Sponsor
United Therapeutics
Registration Number
NCT02149095
Locations
🇺🇸

PPD Development, Austin, Texas, United States

Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension

Not Applicable
Withdrawn
Conditions
Congenital Heart Disease
Interventions
First Posted Date
2013-11-11
Last Posted Date
2017-09-21
Lead Sponsor
University of California, Los Angeles
Registration Number
NCT01980979
Locations
🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

Ohio State University/Nationwide Children's Hospital, Columbus, Ohio, United States

A Pharmacokinetic Substudy of the TDE-PH-304 Protocol

Phase 3
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2013-09-04
Last Posted Date
2024-01-03
Lead Sponsor
United Therapeutics
Target Recruit Count
13
Registration Number
NCT01934582
Locations
🇺🇸

University of Rochester Medical Center, Rochester, New York, United States

Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients

Phase 2
Withdrawn
Conditions
Liver Transplant
Interventions
First Posted Date
2013-06-21
Last Posted Date
2023-12-19
Lead Sponsor
United Therapeutics
Registration Number
NCT01884038
Locations
🇺🇸

University of Pittsburgh Medical Center, Starzl Transplantation Institute, Pittsburgh, Pennsylvania, United States

Three Times Daily Dosing of UT-15C

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2012-12-11
Last Posted Date
2012-12-12
Lead Sponsor
United Therapeutics
Target Recruit Count
19
Registration Number
NCT01746485
Locations
🇺🇸

PPD Development, Austin, Texas, United States

Remodulin® to Oral Treprostinil Transition

Phase 2
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2012-05-01
Last Posted Date
2016-05-16
Lead Sponsor
United Therapeutics
Target Recruit Count
33
Registration Number
NCT01588405
Locations
🇺🇸

Arizona Pulmonary Specialists, Phoenix, Arizona, United States

🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

🇺🇸

University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania, United States

and more 3 locations

Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy

Phase 3
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2012-03-22
Last Posted Date
2020-02-13
Lead Sponsor
United Therapeutics
Target Recruit Count
690
Registration Number
NCT01560624
Locations
🇺🇸

University of Arizona, Tucson, Arizona, United States

🇺🇸

University of Florida College of Medicine Jacksonville, Jacksonville, Florida, United States

🇨🇳

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

and more 151 locations

Inhaled Treprostinil for PAH: Open-label Extension

Phase 3
Withdrawn
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2012-03-19
Last Posted Date
2012-03-26
Lead Sponsor
United Therapeutics
Registration Number
NCT01557660
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