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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 and Efficacy of Inhaled Treprostinil in Patients With PAH

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Withdrawn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
NCT01557647

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

Phase 1
Completed
Conditions
Ischemia Reperfusion Injury
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

Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso®

Phase 2
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2011-11-22
Last Posted Date
2023-12-27
Lead Sponsor
United Therapeutics
Target Recruit Count
18
Registration Number
NCT01477333
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

The University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 3 locations

Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)

Phase 3
Completed
Conditions
Non-operable Chronic Thromboembolic Pulmonary Hypertension
Interventions
First Posted Date
2011-08-15
Last Posted Date
2022-06-07
Lead Sponsor
SciPharm SàRL
Target Recruit Count
105
Registration Number
NCT01416636
Locations
🇦🇹

Krankenhaus der Elisabethinen, Linz, Austria

🇨🇿

II. interní klinika Všeobecná fakultní nemocnice, Prague, Czechia

🇵🇱

NZOZ Europejskie Centrum Zdrowia Otwock, Otwock, Poland

and more 3 locations

A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil).

Phase 4
Completed
Conditions
Hypertension, Pulmonary
Interventions
First Posted Date
2011-02-28
Last Posted Date
2017-06-02
Lead Sponsor
Stanford University
Target Recruit Count
21
Registration Number
NCT01305252
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication

Phase 4
Completed
Conditions
Pulmonary Arterial Hypertension
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

A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-07-29
Last Posted Date
2010-10-13
Lead Sponsor
United Therapeutics
Target Recruit Count
24
Registration Number
NCT01172496
Locations
🇺🇸

PPD Development, Austin, Texas, United States

Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-07-19
Last Posted Date
2011-04-19
Lead Sponsor
United Therapeutics
Target Recruit Count
64
Registration Number
NCT01165476
Locations
🇺🇸

PPD Development, Austin, Texas, United States

Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2010-06-30
Last Posted Date
2010-08-23
Lead Sponsor
United Therapeutics
Target Recruit Count
36
Registration Number
NCT01153386
Locations
🇺🇸

PPD Development, Austin, Texas, United States

A Dose Response Study of UT-15C SR in Patients With Exercise-Induced Pulmonary Hypertension

Phase 2
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2010-04-16
Last Posted Date
2016-05-27
Lead Sponsor
United Therapeutics
Target Recruit Count
50
Registration Number
NCT01104870
Locations
🇺🇸

The Ohio State University Medical Center, Columbus, Ohio, United States

🇺🇸

The Carl and Edyth Lindner Research Center at The Christ Hospital, Cincinnati, Ohio, United States

🇺🇸

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

and more 6 locations
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