TYVASO DPI (treprostinil)
Tyvaso DPI treats pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. It helps patients with these conditions improve their exercise ability, particularly those experiencing NYHA Functional Class III symptoms. This medication is used for patients with idiopathic or heritable forms of the disease, as well as those whose condition is linked to connective tissue diseases or interstitial lung diseases like pulmonary fibrosis.
How TYVASO DPI Works
This medication works by mimicking the effects of prostacyclin to cause direct vasodilation of the pulmonary and systemic arterial vascular beds. It also helps by inhibiting platelet aggregation. These actions facilitate the widening of blood vessels to improve blood flow and reduce pressure.
Details
- Status
- Prescription
- First Approved
- 2022-05-23
- Patent Cliff
- 2042
- Routes
- INHALATION
- Dosage Forms
- POWDER
TYVASO DPI Approval History
What TYVASO DPI Treats
3 indicationsTYVASO DPI is approved for 3 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Interstitial Lung Disease
TYVASO DPI Competitive Set
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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 TYVASO DPI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TYVASO DPI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TYVASO DPI
3 of 20FDA-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.
TYVASO DPI FDA Label Details
Indications & Usage
FDA Label (PDF)TYVASO DPI is indicated for the treatment of Pulmonary Arterial Hypertension; Pulmonary Hypertension; Interstitial Lung Disease.
TYVASO DPI Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for TYVASO DPI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 150 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.