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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)

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH

Phase 3
Recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2019-08-20
Last Posted Date
2025-02-20
Lead Sponsor
University of Arizona
Target Recruit Count
20
Registration Number
NCT04062565
Locations
🇺🇸

University of Arizona, Tucson, Arizona, United States

Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation

Phase 1
Recruiting
Conditions
Ischemia Reperfusion Injury
Delayed Graft Function
Interventions
First Posted Date
2019-07-02
Last Posted Date
2023-07-20
Lead Sponsor
Rhode Island Hospital
Target Recruit Count
20
Registration Number
NCT04005469
Locations
🇺🇸

Rhode Island Hospital, Providence, Rhode Island, United States

Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2019-05-15
Last Posted Date
2024-11-01
Lead Sponsor
United Therapeutics
Target Recruit Count
51
Registration Number
NCT03950739
Locations
🇺🇸

Ascension / St. Vincent's Lung Institute, Jacksonville, Florida, United States

🇺🇸

Mayo Clinic Florida, Jacksonville, Florida, United States

🇺🇸

University of South Florida Center for Advanced Lung Disease, Tampa, Florida, United States

and more 13 locations

Patient Global Impression Questions for Activity-Induced Symptoms in Participants With PAH

Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2019-03-25
Last Posted Date
2021-03-16
Lead Sponsor
United Therapeutics
Target Recruit Count
43
Registration Number
NCT03888365
Locations
🇺🇸

Cedars-Sinai Medical Center, Beverly Hills, California, United States

🇺🇸

The Mount Sinai Hospital, New York, New York, United States

🇺🇸

Pulmonary Health Physicians, PC, Fayetteville, New York, United States

and more 7 locations

Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension

Phase 4
Recruiting
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2019-02-08
Last Posted Date
2022-12-15
Lead Sponsor
Magdi H. Yacoub
Target Recruit Count
30
Registration Number
NCT03835676
Locations
🇪🇬

Aswan Heart Centre - Magdi Yacoub Heart Foundation, Aswan, Egypt

Inhaled Treprostinil in Sarcoidosis Patients With Pulmonary Hypertension

Phase 2
Recruiting
Conditions
Interstitial Lung Disease
Sarcoidosis
Precapillary Pulmonary Hypertension
Interventions
First Posted Date
2019-01-24
Last Posted Date
2024-05-28
Lead Sponsor
University of Florida
Target Recruit Count
10
Registration Number
NCT03814317
Locations
🇺🇸

University of Florida, Division of Pulmonary and Critical Care Medicine, Gainesville, Florida, United States

Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Phase 3
Terminated
Conditions
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Interventions
First Posted Date
2019-01-07
Last Posted Date
2023-12-18
Lead Sponsor
United Therapeutics
Target Recruit Count
41
Registration Number
NCT03794583
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

University of Illinois Medical Center, Chicago, Illinois, United States

and more 27 locations

Iontophoresis of Treprostinil to Enhance Wound Healing in Diabetic Foot Skin Ulcers

Phase 1
Terminated
Conditions
Diabetic Foot Ulcer
Interventions
Device: Remodulin® placebo iontophoresis
First Posted Date
2018-08-31
Last Posted Date
2023-12-12
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
4
Registration Number
NCT03654989
Locations
🇫🇷

CHU Grenoble Alpes, Grenoble, France

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)

Phase 3
Terminated
Conditions
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Interventions
First Posted Date
2018-04-12
Last Posted Date
2023-11-24
Lead Sponsor
United Therapeutics
Target Recruit Count
188
Registration Number
NCT03496623
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

🇺🇸

Pulmonary & Critical Care of Atlanta, Atlanta, Georgia, United States

🇺🇸

St. Vincent Medical Group, Inc., Indianapolis, Indiana, United States

and more 73 locations

Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2018-03-14
Last Posted Date
2018-10-30
Lead Sponsor
Mannkind Corporation
Target Recruit Count
36
Registration Number
NCT03464864
Locations
🇺🇸

Investigational Site 441, San Antonio, Texas, United States

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