Treprostinil

Generic Name: Treprostinil

Brand Names: Orenitram, Remodulin, Tyvaso, Trepulmix

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₃₄O_₅

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)

Clinical Trials

Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: NaCl 0.9%
Drug: treprostinil
Drug: iloprost

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

Completed

Conditions: Pulmonary Hypertension
Pulmonary Arterial Hypertension
Portopulmonary Hypertension

Interventions: Drug: Treprostinil

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

An Open-Label Extension Trial of UT-15C Sustained-release (SR) in Subjects With Pulmonary Arterial Hypertension

Phase 3

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Oral Treprostinil

First Posted Date: 2009-12-09

Last Posted Date: 2021-05-10

Lead Sponsor: United Therapeutics

Target Recruit Count: 894

Registration Number: NCT01027949

Locations: 🇩🇪
Zentrum für Lungenhochdruck Thoraxklinik am Universitätsklinikum Heidelberg, Hamburg, Germany
🇮🇹
Dipartimento di Scienze Cardiovascolari, Respiratorie e Morfologiche, Rome, Italy
🇲🇽
Unidad de Investigacion Clinica en Medicina S.C., Monterrey, Mexico

and more 131 locations

Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

Phase 1

Completed

Conditions: Hypertension, Pulmonary
Pulmonary Arterial Hypertension

First Posted Date: 2009-08-20

Last Posted Date: 2010-03-08

Lead Sponsor: United Therapeutics

Target Recruit Count: 30

Registration Number: NCT00963027

Locations: 🇺🇸
PPD Development, Austin, Texas, United States

Effect of Food on the Pharmacokinetics of Oral Treprostinil

Phase 1

Completed

Conditions: Hypertension, Pulmonary
Pulmonary Arterial Hypertension

First Posted Date: 2009-08-20

Last Posted Date: 2010-03-08

Lead Sponsor: United Therapeutics

Target Recruit Count: 32

Registration Number: NCT00963001

Locations: 🇺🇸
PPD Development, Austin, Texas, United States

Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension

Phase 3

Completed

Conditions: Pulmonary Hypertension

Interventions: Drug: Placebo
Drug: UT-15C SR

First Posted Date: 2009-04-24

Last Posted Date: 2013-01-15

Lead Sponsor: United Therapeutics

Target Recruit Count: 310

Registration Number: NCT00887978

Locations: 🇺🇸
Washington University Hospital, St. Louis, Missouri, United States
🇨🇦
Toronto General Hospital, Toronto, Ontario, Canada
🇺🇸
Emory University School of Medicine, Atlanta, Georgia, United States

and more 59 locations

Open-Label Study of Oral Treprostinil in Digital Ulcers

Phase 2

Terminated

Conditions: Systemic Sclerosis

Interventions: Drug: treprostinil diethanolamine

First Posted Date: 2009-02-20

Last Posted Date: 2024-06-18

Lead Sponsor: United Therapeutics

Target Recruit Count: 115

Registration Number: NCT00848107

Locations: 🇺🇸
Northwestern University - Feinberg School of Medicine, Chicago, Illinois, United States
🇺🇸
Boston University School of Medicine, Boston, Massachusetts, United States
🇺🇸
The Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 23 locations

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

Phase 1

Completed

Conditions: Systemic Sclerosis

Interventions: Drug: treprostinil diethanolamine

First Posted Date: 2009-02-20

Last Posted Date: 2012-10-23

Lead Sponsor: United Therapeutics

Target Recruit Count: 28

Registration Number: NCT00848939

Locations: 🇺🇸
Johns Hopkins Scleroderma Center, Baltimore, Maryland, United States
🇺🇸
University of Michigan Scleroderma Program, Ann Arbor, Michigan, United States
🇺🇸
Boston University School of Medicine Rheumatology Arthritis Center, Boston, Massachusetts, United States

Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine

Phase 2

Completed

Conditions: Scleroderma
Systemic Sclerosis

Interventions: Drug: treprostinil diethanolamine
Drug: placebo

First Posted Date: 2008-10-20

Last Posted Date: 2023-12-28

Lead Sponsor: United Therapeutics

Target Recruit Count: 148

Registration Number: NCT00775463

Locations: 🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Indiana School of Medicine, Indianapolis, Indiana, United States
🇺🇸
University of Connecticut Health Center, Farmington, Connecticut, United States

and more 27 locations

Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects

Phase 4

Completed

Conditions: Pulmonary Arterial Hypertension

Interventions: Drug: Inhaled treprostinil

First Posted Date: 2008-08-26

Last Posted Date: 2013-02-20

Lead Sponsor: United Therapeutics

Target Recruit Count: 73

Registration Number: NCT00741819

Locations: 🇺🇸
Cornell University Medical Center, New York City, New York, United States
🇺🇸
Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
🇺🇸
University of Alabama Birmingham, Birmingham, Alabama, United States

and more 12 locations

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