TREPROSTINIL
TREPROSTINIL is indicated for the treatment of Pulmonary Arterial Hypertension.
How TREPROSTINIL Works
Treprostinil acts by inducing direct vasodilation of the pulmonary and systemic arterial vascular beds and inhibiting platelet aggregation. These pharmacologic actions reduce pulmonary vascular resistance and improve systemic blood flow.
Details
- Status
- Prescription
- First Approved
- 2002-05-21
- Routes
- INTRAVENOUS, SUBCUTANEOUS, ORAL
- Dosage Forms
- INJECTABLE, TABLET, EXTENDED RELEASE
TREPROSTINIL Approval History
What TREPROSTINIL Treats
1 indicationsTREPROSTINIL is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
TREPROSTINIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TREPROSTINIL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TREPROSTINIL treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TREPROSTINIL
3 of 18FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04005469 | 974570-5 | Ph 1, Ph 2 | recruiting | Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation |
| NCT05564637 results posted | 22-004971 | Ph 2 | completed | A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension |
| NCT07177703 | Tre-ImPAH | Ph 2 | not yet recruiting | Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension |
| NCT01481974 | STUDY19100094 | Ph 1 | completed | Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation |
| NCT05067270 results posted | 18278 I8B-MC-ITTC, 2021-001987-18 | Ph 1 | completed | A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus |
| NCT04675944 | BIA-51058-106 2017-000245-43 | Ph 1 | completed | Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil |
| NCT00705133 results posted | 07-11-087-01 | Ph 2 | completed | Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension |
| NCT02769624 results posted | 2015-1491 | Ph 2 | terminated | Acute Effects of Inhaled Treprostinil in Fontan Patients |
| NCT02770521 results posted | 16071 I8B-JE-ITRK | Ph 1 | completed | A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants |
| NCT01268553 results posted | Tyvaso Switch | Ph 4 | completed | Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication |
| NCT01082484 INFLUX-IT-VS | 2009-016301-42 | Ph 1, Ph 2 | completed | Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TREPROSTINIL FDA Label Details
Indications & Usage
FDA Label (PDF)TREPROSTINIL is indicated for the treatment of Pulmonary Arterial Hypertension.
Looking for the branded version?
TYVASO DPI
Full clinical data, patents, trials, and competitive landscape for treprostinil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.