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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)

Treprostinil Iontophoresis in Systemic Sclerosis Digital UlcErations. A Proof of Concept Study

Phase 1
Completed
Conditions
Scleroderma, Systemic
Interventions
Drug: Iontophoresis of placebo
First Posted Date
2017-04-19
Last Posted Date
2020-04-10
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
18
Registration Number
NCT03120533
Locations
🇫🇷

Grenoble Alps University Hospital, Grenoble, France

Study to Evaluate Efficacy and Safety of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Sickle Cell Disease (SCD)

Phase 3
Withdrawn
Conditions
Pulmonary Hypertension Associated With Sickle Cell Disease
Interventions
First Posted Date
2017-02-16
Last Posted Date
2017-04-11
Lead Sponsor
United Therapeutics
Registration Number
NCT03055234

ADAPT - a Patient Registry of the Real-world Use of Orenitram®

Active, not recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2017-02-07
Last Posted Date
2025-03-28
Lead Sponsor
United Therapeutics
Target Recruit Count
300
Registration Number
NCT03045029
Locations
🇺🇸

University of Pittsburgh - Heart and Vascular Medicine Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

University of Southern California - Keck Medical Center, Los Angeles, California, United States

🇺🇸

Saint Vincent Hospital and Health Services, Indianapolis, Indiana, United States

and more 38 locations

Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

Phase 3
Terminated
Conditions
Pulmonary Hypertension Associated With HFpEF
Interventions
First Posted Date
2017-02-06
Last Posted Date
2020-10-22
Lead Sponsor
United Therapeutics
Target Recruit Count
48
Registration Number
NCT03043651
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

VA Healthcare System of Greater Los Angeles, Los Angeles, California, United States

🇺🇸

University of Arizona, Tucson, Arizona, United States

and more 79 locations

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction

Phase 3
Terminated
Conditions
Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension
Interventions
First Posted Date
2017-01-31
Last Posted Date
2020-11-10
Lead Sponsor
United Therapeutics
Target Recruit Count
84
Registration Number
NCT03037580
Locations
🇺🇸

Medical Faculty Associates, George Washington University, Washington, District of Columbia, United States

🇺🇸

Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

🇺🇸

St. Vincent's Lung, Sleep, and Critical Care Specialists, Jacksonville, Florida, United States

and more 79 locations

Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

Phase 2
Withdrawn
Conditions
Pulmonary Arterial Hypertension
Interventions
Drug: Parenteral Remodulin (treprostinil) injection
First Posted Date
2017-01-10
Last Posted Date
2017-04-11
Lead Sponsor
United Therapeutics
Registration Number
NCT03016468

Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD

Phase 2
Withdrawn
Conditions
Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Interventions
First Posted Date
2017-01-06
Last Posted Date
2017-04-11
Lead Sponsor
United Therapeutics
Registration Number
NCT03012646

Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension

Phase 3
Withdrawn
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2016-12-21
Last Posted Date
2017-11-01
Lead Sponsor
United Therapeutics
Registration Number
NCT02999906

Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery

Phase 3
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2016-08-12
Last Posted Date
2020-10-28
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Target Recruit Count
36
Registration Number
NCT02865733

Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID)

Phase 4
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2016-07-28
Last Posted Date
2017-10-17
Lead Sponsor
United Therapeutics
Target Recruit Count
39
Registration Number
NCT02847260
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