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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)

A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2016-05-12
Last Posted Date
2020-06-04
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
23
Registration Number
NCT02770521
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fukuoka, Japan

Acute Effects of Inhaled Treprostinil in Fontan Patients

Phase 2
Terminated
Conditions
Congenital Heart Disease
Interventions
Drug: Placebo
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

Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis

Phase 2
Completed
Conditions
Systemic Sclerosis
Calcinosis
Interventions
First Posted Date
2016-01-26
Last Posted Date
2021-06-10
Lead Sponsor
Stanford University
Target Recruit Count
12
Registration Number
NCT02663895
Locations
🇺🇸

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

An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE

Phase 2
Terminated
Conditions
Pulmonary Hypertension
Interstitial Lung Disease
Combined Pulmonary Fibrosis and Emphysema
Interventions
First Posted Date
2015-12-17
Last Posted Date
2022-12-02
Lead Sponsor
United Therapeutics
Target Recruit Count
243
Registration Number
NCT02633293
Locations
🇺🇸

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

🇺🇸

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

and more 89 locations

Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

Phase 2
Completed
Conditions
Pulmonary Hypertension
Combined Pulmonary Fibrosis and Emphysema
Interstitial Lung Disease
Interventions
First Posted Date
2015-12-15
Last Posted Date
2022-07-27
Lead Sponsor
United Therapeutics
Target Recruit Count
326
Registration Number
NCT02630316
Locations
🇺🇸

Wellstar Medical Group - Pulmonary Medicine, Marietta, Georgia, United States

🇺🇸

Johns Hopkins University Pulmonary and Critical Care Medicine, Baltimore, Maryland, United States

🇺🇸

Penn Medicine University City, Philadelphia, Pennsylvania, United States

and more 94 locations

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Phase 2
Withdrawn
Conditions
Pulmonary Hypertension
Pulmonary Fibrosis
Interventions
First Posted Date
2015-11-11
Last Posted Date
2016-02-09
Lead Sponsor
United Therapeutics
Registration Number
NCT02603068
Locations
🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

🇺🇸

CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Banner University Medical Center Phoenix Advanced Lung Disease, Phoenix, Arizona, United States

and more 4 locations

Assess Efficacy of of Oral Treprostinil in Patients With Symptomatic Primary or Secondary Raynaud's Phenomenon

Early Phase 1
Completed
Conditions
Raynaud's Phenomenon
Interventions
First Posted Date
2015-10-22
Last Posted Date
2022-01-10
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
12
Registration Number
NCT02583789
Locations
🇺🇸

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

Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation

Not Applicable
Terminated
Conditions
Single Ventricle
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

Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

Phase 2
Terminated
Conditions
Respiratory Distress Syndrome, Adult
Interventions
First Posted Date
2015-02-24
Last Posted Date
2019-10-01
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
14
Registration Number
NCT02370095
Locations
🇺🇸

University of North Carolina Hospitals, Chapel Hill, North Carolina, United States

Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Other: ethanol
First Posted Date
2014-12-17
Last Posted Date
2015-03-24
Lead Sponsor
United Therapeutics
Target Recruit Count
32
Registration Number
NCT02318758
Locations
🇺🇸

PPD International, Austin, Texas, United States

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