MedPath

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)

Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Phase 3
Active, not recruiting
Conditions
Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Interventions
Drug: Placebo
Device: Treprostinil Ultrasonic Nebulizer
First Posted Date
2022-02-25
Last Posted Date
2025-03-05
Lead Sponsor
United Therapeutics
Target Recruit Count
597
Registration Number
NCT05255991
Locations
🇵🇪

Hospital de Chancay y Servicios Basicos deSalud, Huaral, Lima, Peru

🇵🇪

Clinica Ricardo Palma, Lima, Peru

🇵🇪

Hospital Central de la Fuerza Aerea Del Peru, Lima, Peru

and more 105 locations

A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension

Phase 4
Active, not recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
Drug: Parenteral Treprostinil
First Posted Date
2022-01-24
Last Posted Date
2025-04-30
Lead Sponsor
United Therapeutics
Target Recruit Count
52
Registration Number
NCT05203510
Locations
🇺🇸

Banner University Medical Center (University of Arizona), Phoenix, Arizona, United States

🇺🇸

HonorHealth John C. Lincoln Medical Center, Phoenix, Arizona, United States

🇺🇸

University of California San Francisco - Fresno, Fresno, California, United States

and more 25 locations

A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

Phase 2
Completed
Conditions
Pulmonary Hypertension
Interventions
First Posted Date
2022-01-04
Last Posted Date
2025-03-17
Lead Sponsor
Insmed Incorporated
Target Recruit Count
39
Registration Number
NCT05176951
Locations
🇦🇺

AUS003, Camperdown, New South Wales, Australia

🇦🇺

AUS005, Macquarie Park, New South Wales, Australia

🇧🇪

BEL002, Liège, Belgium

and more 22 locations

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Phase 2
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2021-12-07
Last Posted Date
2025-04-10
Lead Sponsor
Insmed Incorporated
Target Recruit Count
102
Registration Number
NCT05147805
Locations
🇦🇷

ARG001, Córdoba, Argentina

🇧🇪

BEL001, Liège, Belgium

🇯🇵

JPN009, Nagasaki-Shi, Nagasaki, Japan

and more 89 locations

A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus

Phase 1
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2021-10-05
Last Posted Date
2023-10-04
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
40
Registration Number
NCT05067270
Locations
🇩🇪

Profil Institut für Stoffwechselforschung, Neuss, Nordrhein-Westfalen, Germany

🇩🇪

Profil Mainz, Mainz, Germany

Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Phase 3
Conditions
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Interventions
Device: Treprostinil Ultrasonic Nebulizer
First Posted Date
2021-05-28
Last Posted Date
2025-04-25
Lead Sponsor
United Therapeutics
Target Recruit Count
792
Registration Number
NCT04905693
Locations
🇺🇸

Community Health Network, Indianapolis, Indiana, United States

🇺🇸

PulmonIx, LLC, Greensboro, North Carolina, United States

🇫🇷

Hôpital Bretonneau, Tours, Indre-et-Loire, France

and more 165 locations

Telemonitoring to Treat Group 2 Pulmonary Hypertension

Phase 2
Withdrawn
Conditions
Pulmonary Hypertension Due to Left Heart Disease
Interventions
First Posted Date
2021-05-12
Last Posted Date
2023-06-06
Lead Sponsor
Mardi Gomberg -Maitland MD, MSc
Registration Number
NCT04882774
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

🇺🇸

George Washington University, Washington, District of Columbia, United States

🇺🇸

Allegheny Singer Research Institute, Pittsburgh, Pennsylvania, United States

A Study of Treprostinil Palmitil Inhalation Powder (TPIP) In Pulmonary Arterial Hypertension (PAH)

Phase 2
Terminated
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2021-03-10
Last Posted Date
2023-09-22
Lead Sponsor
Insmed Incorporated
Target Recruit Count
1
Registration Number
NCT04791514
Locations
🇺🇸

USA002, New York, New York, United States

Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

Phase 3
Active, not recruiting
Conditions
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Interventions
Drug: Placebo
Device: Treprostinil Ultrasonic Nebulizer
First Posted Date
2021-01-14
Last Posted Date
2025-04-25
Lead Sponsor
United Therapeutics
Target Recruit Count
576
Registration Number
NCT04708782
Locations
🇺🇸

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

🇺🇸

Banner University Medical Center-Phoenix, Phoenix, Arizona, United States

🇺🇸

Arizona Pulmonary Specialists, Ltd., Phoenix, Arizona, United States

and more 98 locations

Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil

Phase 1
Completed
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2020-12-19
Last Posted Date
2020-12-19
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
20
Registration Number
NCT04675944
Locations
🇩🇪

PAREXEL International - Early Phase Clinical Unit, Berlin, Germany

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