NDAINHALATIONPOWDERPriority Review
Approved
May 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
TYVASO DPI (treprostinil) by United Therapeutics is beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. First approved in 2022.
Drug data last refreshed 2h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYVASO DPI is an inhalation powder formulation of treprostinil, a prostacycline vasodilator approved in May 2022 for pulmonary arterial hypertension (PAH). It reduces pulmonary vascular resistance through vasodilation, inhibition of platelet aggregation, and suppression of smooth muscle cell proliferation. The dry powder inhaler (DPI) route offers a non-invasive alternative to intravenous or subcutaneous administration.
$0.437BPart D
Peak15.4 years to LOEProduct is at peak revenue stage with strong Medicare uptake; commercial team is likely operating at full scale with mature field presence and established reimbursement infrastructure.
Mechanism of Action
beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
Pharmacologic Class:
Prostacycline Vasodilator
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
Worked on TYVASO DPI at United Therapeutics? Share your interview experience or compensation data (+7 days Pro)
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.