TYVASO (treprostinil)
Tyvaso treats pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease to help patients improve their exercise capacity. It is used for individuals with significant symptoms, including those with idiopathic conditions or those related to connective tissue diseases and pulmonary fibrosis. Because the effects of the medication diminish over a few hours, patients can adjust the timing of their doses to support planned physical activities.
How TYVASO Works
As a prostacyclin mimetic, this medication works by directly dilating the vascular beds in the lungs and throughout the body. This process reduces blood pressure in the arteries while also helping to inhibit the aggregation of platelets.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-07-30
- Patent Cliff
- 2042
- Routes
- INHALATION
- Dosage Forms
- SOLUTION
TYVASO Approval History
What TYVASO Treats
2 indicationsTYVASO is approved for 2 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension associated with Interstitial Lung Disease
TYVASO 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 TYVASO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TYVASO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TYVASO
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.
TYVASO FDA Label Details
Indications & Usage
FDA Label (PDF)TYVASO is indicated for the treatment of Pulmonary Arterial Hypertension; Pulmonary Hypertension associated with Interstitial Lung Disease.
TYVASO Patents & Exclusivity
Patents (6 active)
Pro Intelligence Preview
Deep insights for TYVASO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 6 active patents
Trial Analysis
- • 12 total trials
- • Stage: Declining
Competitive Landscape
- • 18 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment