NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2013
Lifecycle
Peak
Competitive Pressure
8/100
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 17h ago · AI intelligence enriched 1mo 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 (PAH). It works by dilating pulmonary and systemic arterial beds, inhibiting platelet aggregation, and reducing smooth muscle cell proliferation. The oral formulation represents a significant advance over IV treprostinil, improving patient convenience and quality of life.
Peak4.8 years to LOE
Product is in peak revenue phase with mature market positioning; brand teams are focused on maintaining share against moderately high competitive pressure rather than driving new growth.
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
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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.