NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
ORENITRAM (treprostinil) by United Therapeutics is beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. First approved in 2013.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORENITRAM (treprostinil) is an oral extended-release prostacycline vasodilator approved in 2013 for pulmonary arterial hypertension. It works by dilating pulmonary and systemic arteries, inhibiting platelet aggregation, and reducing smooth muscle cell proliferation. The drug represents a significant advancement in converting IV/SC treprostinil to an oral formulation for improved patient convenience.
Peak5.1 years to LOE
Product is at peak lifecycle stage with stable market presence; the brand team is likely focused on optimization and lifecycle management rather than aggressive growth initiatives.
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 Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)
Started Jun 2026
344 enrolled
Pulmonary Arterial Hypertension
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 Jun 2026
30 enrolled
Hepatic Impairment
An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Started Jun 2026
344 enrolled
Pulmonary HypertensionInterstitial Lung Disease
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
Effects of Inhaled Treprostinil on Exercise Performance in Exercise Induced Pulmonary Hypertension
Started Oct 2025
8 enrolled
Pulmonary Hypertension
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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.