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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)

Study of Remodulin in Patients With Critical Limb Ischemia With No Planned Revascularization Procedures

Phase 3
Terminated
Conditions
Peripheral Vascular Disease
Foot Ulcers
Rest Leg Pain
Critical Limb Ischemia
First Posted Date
2003-05-20
Last Posted Date
2013-03-07
Lead Sponsor
United Therapeutics
Target Recruit Count
30
Registration Number
NCT00060996
Locations
🇺🇸

South Carolina Heart Center, Columbia, South Carolina, United States

🇺🇸

University of Massachusetts Memorial Health, Worcester, Massachusetts, United States

🇺🇸

Minneapolis Heart Institute, Minneapolis, Minnesota, United States

and more 4 locations

A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension

Phase 4
Completed
Conditions
Pulmonary Arterial Hypertension
Pulmonary Hypertension
First Posted Date
2003-04-16
Last Posted Date
2013-03-07
Lead Sponsor
United Therapeutics
Target Recruit Count
39
Registration Number
NCT00058929
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

The Rush Heart Institute Center for Pulmonary Heart Disease, Chicago, Illinois, United States

and more 5 locations

Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension

Phase 3
Completed
Conditions
Pulmonary Hypertension
First Posted Date
1999-10-19
Last Posted Date
2015-03-25
Lead Sponsor
United Therapeutics
Registration Number
NCT00004497
Locations
🇺🇸

Los Angeles County Harbor-UCLA Medical Center, Torrance, California, United States

🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

🇺🇸

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States

and more 4 locations
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