NDAINTRAVENOUS, SUBCUTANEOUSINJECTABLEPriority Review
Approved
May 2002
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
REMODULIN (treprostinil) by United Therapeutics is beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. First approved in 2002.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REMODULIN (treprostinil) is a prostacycline vasodilator administered via intravenous or subcutaneous injection that reduces pulmonary vascular resistance through vasodilation, platelet aggregation inhibition, and smooth muscle cell proliferation suppression. It is indicated for pulmonary arterial hypertension (PAH) and related conditions requiring sustained hemodynamic support. The drug has been a cornerstone therapy since its 2002 approval, offering chronic infusion or continuous subcutaneous delivery for symptomatic patients.
LOE Approaching2.5 years to LOE
Product faces near-term LOE (2029), signaling contraction in commercial team size and shift toward life-cycle management and generic transition planning.
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.