NDAINHALATIONPOWDER
Approved
May 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
YUTREPIA (treprostinil) by United Therapeutics is beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. First approved in 2025.
Drug data last refreshed 3h ago · AI intelligence enriched 10h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YUTREPIA (treprostinil) is an inhaled powder prostacyclin analog approved in May 2025 for pulmonary hypertension. It works by vasodilation of pulmonary and systemic arterial beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. The inhalation formulation represents a novel delivery route for an established therapeutic class.
Growth10.6 years to LOE
As a newly approved product in the growth phase, YUTREPIA has significant team expansion potential with opportunities in field sales, market access, and commercial operations.
Mechanism of Action
beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
Started Dec 2026
800 enrolled
Progressive Pulmonary FibrosisInterstitial Lung Disease
A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Started Jul 2026
344 enrolled
Pulmonary Arterial Hypertension
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Started Jul 2026
344 enrolled
Pulmonary HypertensionInterstitial Lung Disease
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Started Jul 2026
30 enrolled
Hepatic Impairment
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Started Jan 2026
344 enrolled
Pulmonary HypertensionInterstitial Lung Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.