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)
Associated Therapies
-

Acute Effects of Inhaled Treprostinil in Fontan Patients

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2016-05-11
Last Posted Date
2020-07-29
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
15
Registration Number
NCT02769624
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2015-07-15
Last Posted Date
2022-03-31
Lead Sponsor
Stanford University
Target Recruit Count
34
Registration Number
NCT02498444
Locations
🇺🇸

Lucile Packard Children's Hospital, Stanford, Palo Alto, California, United States

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

Not Applicable
Withdrawn
Conditions
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

Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-11-30
Last Posted Date
2023-12-15
Lead Sponsor
Abhinav Humar, MD
Target Recruit Count
35
Registration Number
NCT01481974
Locations
🇺🇸

Abhinav Humar, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Phase 4
Completed
Conditions
Interventions
First Posted Date
2010-12-31
Last Posted Date
2017-09-01
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Target Recruit Count
6
Registration Number
NCT01268553
Locations
🇺🇸

Harbor-UCLA Medical Center, Torrance, California, United States

🇺🇸

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

🇺🇸

University of Arizona, Tucson, Arizona, United States

Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-03-08
Last Posted Date
2011-10-06
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
20
Registration Number
NCT01082484
Locations
🇫🇷

Unité de Pharmacologie Clinique, Inserm CIC3, CHU Grenoble, Grenoble, France

A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension

First Posted Date
2009-12-09
Last Posted Date
2017-02-24
Lead Sponsor
United Therapeutics
Target Recruit Count
13
Registration Number
NCT01028651
Locations
🇺🇸

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

🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

Emory Univeristy, Atlanta, Georgia, United States

and more 1 locations

Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

First Posted Date
2008-06-25
Last Posted Date
2020-09-09
Lead Sponsor
Rajan Saggar
Target Recruit Count
15
Registration Number
NCT00705133
Locations
🇺🇸

David Geffen School of Medicine, UCLA, Los Angeles, California, United States

Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

First Posted Date
2007-02-26
Last Posted Date
2024-01-03
Lead Sponsor
United Therapeutics
Target Recruit Count
8
Registration Number
NCT00439946
Locations
🇺🇸

THE NEW YORK-PRESBYTERIAN HOSPITAL Weill Cornell Medical Center, New York, New York, United States

🇺🇸

University of California San Francisco (UCSF) Medical Center, San Francisco, California, United States

🇺🇸

Integris Baptist Medical Center, Oklahoma City, Oklahoma, United States

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