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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 Post Trial Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH)

Conditions
Pulmonary Arterial Hypertension
First Posted Date
2025-04-23
Last Posted Date
2025-04-23
Lead Sponsor
Insmed Incorporated
Registration Number
NCT06939647

A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin

Not yet recruiting
Conditions
Pulmonary Arterial Hypertension
First Posted Date
2024-09-19
Last Posted Date
2025-02-26
Lead Sponsor
Excelsior
Target Recruit Count
20
Registration Number
NCT06603285

Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH

Phase 3
Recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2024-04-05
Last Posted Date
2024-08-07
Lead Sponsor
AOP Orphan Pharmaceuticals AG
Target Recruit Count
20
Registration Number
NCT06350032
Locations
🇪🇸

Ramón y Cajal University Hospital, Madrid, Spain

🇫🇷

Necker-Enfants Malades Hospital, Paris, Paris, France

🇭🇺

Gottsegen National Cardiovascular Center, Budapest, Hungary

and more 1 locations

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of C16TR for Inhalation With Tyvaso® Cohort in Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2024-01-05
Last Posted Date
2024-01-05
Lead Sponsor
Insmed Incorporated
Target Recruit Count
24
Registration Number
NCT06193031
Locations
🇺🇸

USA001, Los Angeles, California, United States

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2023-10-19
Last Posted Date
2023-10-19
Lead Sponsor
Insmed Incorporated
Target Recruit Count
42
Registration Number
NCT06091579
Locations
🇺🇸

USA001, Austin, Texas, United States

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

Phase 3
Recruiting
Conditions
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Interventions
Drug: Placebo
Device: Treprostinil Ultrasonic Nebulizer
First Posted Date
2023-07-13
Last Posted Date
2025-05-16
Lead Sponsor
United Therapeutics
Target Recruit Count
698
Registration Number
NCT05943535
Locations
🇺🇸

UAB Lung Health Center, Birmingham, Alabama, United States

🇺🇸

Norton Thoracic Institute, Phoenix, Arizona, United States

🇺🇸

Peter Morton Medical Building, Los Angeles, California, United States

and more 112 locations

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Phase 2
Active, not recruiting
Conditions
Pulmonary Hypertension
Interstitial Lung Disease
Interventions
First Posted Date
2022-12-14
Last Posted Date
2025-04-27
Lead Sponsor
Insmed Incorporated
Target Recruit Count
31
Registration Number
NCT05649722
Locations
🇩🇪

GER010, Gießen, Hessen, Germany

🇩🇪

GER012, Berlin, Germany

🇬🇧

GBR001, Sheffield, South Yorkshire, United Kingdom

and more 19 locations

An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)

Phase 2
Active, not recruiting
Conditions
Pulmonary Arterial Hypertension
Interventions
First Posted Date
2022-12-14
Last Posted Date
2025-04-25
Lead Sponsor
Insmed Incorporated
Target Recruit Count
91
Registration Number
NCT05649748
Locations
🇬🇧

GBR001, Bath, Avon, United Kingdom

🇷🇸

SRB003, Belgrade, Serbia

🇪🇸

ESP003, Sevilla, Spain

and more 42 locations

Inhaled Treprostinil Expanded Access Program in Pulmonary Hypertension Associated With Interstitial Lung Disease

Conditions
Pulmonary Hypertension
Interstitial Lung Disease
Combined Pulmonary Fibrosis and Emphysema
First Posted Date
2022-10-10
Last Posted Date
2022-10-10
Lead Sponsor
Ferrer Internacional S.A.
Registration Number
NCT05572996

A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension

Phase 2
Completed
Conditions
Pulmonary Arterial Hypertension
Interstitial Lung Disease
Healthy Adults
Interventions
Diagnostic Test: Optional Muscle Biopsy
Diagnostic Test: Right Heart Catheterization (RHC) while exercising
First Posted Date
2022-10-03
Last Posted Date
2025-02-04
Lead Sponsor
Mayo Clinic
Target Recruit Count
29
Registration Number
NCT05564637
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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