NDAINTRAVENOUS, SUBCUTANEOUSSOLUTION
Approved
Jul 2018
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
REMODULIN (treprostinil) by United Therapeutics is beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. Approved for pulmonary arterial hypertension, pulmonary hypertension. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REMODULIN (treprostinil) is an intravenous or subcutaneous prostacyclin analog approved in 2018 for pulmonary arterial hypertension (PAH, WHO Group 1). It works through vasodilation of pulmonary and systemic arterial beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation. REMODULIN is indicated to delay disease progression and improve exercise capacity in PAH patients, positioning it as a disease-modifying therapy in the prostacyclin class.
$0.0BPart D
2.6 years to LOEMechanism of Action
beds, inhibition of platelet aggregation, and inhibition of smooth muscle cell proliferation.
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 Apr 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 Apr 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
Inhaled Treprostinil (Tyvaso Nebulizer) For COPD Patients With Hypoxemia
Started Sep 2025
10 enrolled
COPD (Chronic Obstructive Pulmonary Disease)Hypoxemia
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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.