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Remodulin (TREPROSTINIL)
Remodulin works by activating the prostacyclin receptor, which causes blood vessels to relax and widen.
At a glance
| Generic name | TREPROSTINIL |
|---|---|
| Sponsor | United Therap |
| Drug class | Prostacycline Vasodilator [EPC] |
| Target | Prostacyclin receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2002 |
| Annual revenue | 2000 |
Mechanism of action
Treprostinil is prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
Approved indications
- Pulmonary arterial hypertension
- Thromboembolic pulmonary hypertension
Common side effects
- Cough
- Headache
- Dyspnea
- Nausea
- Throat Irritation/Pharyngolaryngeal Pain
- Flushing
- Syncope
- Gastrointestinal effects
- Muscle, jaw or bone pain
- Dizziness
Key clinical trials
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension (PHASE2)
- Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (PHASE3)
- Open Label Treprostinil Raynaud's Study (PHASE4)
- A Phase 3 Study to Evaluate the Safety and Tolerability of L606 in Subjects With PAH or PH-ILD (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) (PHASE3)
- Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (PHASE3)
- Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD (PHASE2)
- An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 8653137 | 2028-09-05 | Method of Use |
| 8658694 | 2028-09-05 | Method of Use |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Remodulin CI brief — competitive landscape report
- Remodulin updates RSS · CI watch RSS
- United Therap portfolio CI