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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REMODULIN (treprostinil) is a synthetic prostacycline vasodilator administered intravenously or subcutaneously. It reduces pulmonary vascular resistance through vasodilation, inhibition of platelet aggregation, and suppression of smooth muscle cell proliferation. The drug is indicated for patients with pulmonary arterial hypertension (PAH) who require continuous infusion therapy.
LOE Approaching2.8 years to LOE
REMODULIN faces moderate competitive pressure (15/100) with LOE approaching in 2029, signaling potential team contraction and transition focus toward lifecycle extension or next-generation products.
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
Worked on REMODULIN 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.