YUTREPIA (treprostinil sodium)
Yutrepia is an inhaled medication that helps patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). It is used to improve exercise ability in people who experience significant symptoms during physical activity, including those with idiopathic or heritable conditions. This therapy also treats patients with lung-related hypertension stemming from connective tissue diseases or various forms of interstitial pneumonia. Because the effects of the drug decrease over a four-hour window, patients can time their doses around planned activities.
How YUTREPIA Works
This medication works by directly dilating the pulmonary and systemic arterial vascular beds, which helps open up the blood vessels. It also functions by inhibiting platelet aggregation. Together, these actions reduce resistance in the circulatory system to improve blood flow and exercise capacity.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-05-23
- Patent Cliff
- 2037
- Routes
- INHALATION
- Dosage Forms
- POWDER
YUTREPIA Approval History
What YUTREPIA Treats
7 indicationsYUTREPIA is approved for 7 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension
- Interstitial Lung Disease
- Idiopathic Interstitial Pneumonia
- Idiopathic Pulmonary Fibrosis
- Combined Pulmonary Fibrosis and Emphysema
- Connective Tissue Disease
YUTREPIA 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 YUTREPIA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications YUTREPIA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to YUTREPIA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00643604 results posted | RIV-PH-413 | Ph 4 | terminated | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic |
| NCT01884038 | RIV-LT-301 | Ph 2, Ph 3 | withdrawn | Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients |
| NCT01416636 CTREPH results posted | 116-02 | Ph 3 | completed | Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH) |
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.
YUTREPIA FDA Label Details
Indications & Usage
FDA Label (PDF)YUTREPIA is indicated for the treatment of Pulmonary Arterial Hypertension; Pulmonary Hypertension; Interstitial Lung Disease; Idiopathic Interstitial Pneumonia; Idiopathic Pulmonary Fibrosis; Combined Pulmonary Fibrosis and Emphysema; Connective Tissue Disease.
YUTREPIA Patents & Exclusivity
Patents (6 active)
Exclusivity
Pro Intelligence Preview
Deep insights for YUTREPIA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2037
- • 96 active patents
Trial Analysis
- • 3 total trials
- • Stage: Declining
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.
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