NDAINHALATIONSOLUTION
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
TYVASO (treprostinil) by United Therapeutics is analogue. First approved in 2009.
Drug data last refreshed 3h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TYVASO (treprostinil) is an inhaled prostacyclin analogue approved in 2009 for pulmonary arterial hypertension (PAH). It works by directly vasodilating pulmonary and systemic arterial vascular beds while inhibiting platelet aggregation. The inhalation route offers patients an alternative to parenteral prostacyclin therapies.
Peak15.4 years to LOE
Peak-stage product with established market presence; mature brand teams typically focus on patient retention and managed care optimization rather than growth expansion.
Mechanism of Action
analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
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
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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.