Data updated: May 26, 2026
REMODULIN (treprostinil)
Cardiovascular
Approved 2002-05-21
4
Indications
--
Phase 3 Trials
2
Priority Reviews
24
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-05-21
- Patent Cliff
- 2029
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- SOLUTION, INJECTABLE
REMODULIN Approval History
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
132 FDA actions from 2002 to 2023 · 2 indication expansions
Jan 2016 SUPPL Priority
Mfg
Jan 2014 SUPPL Priority
Mfg
Nov 2004 SUPPL
Efficacy
What REMODULIN Treats
4 FDA approvalsOriginally approved for its first indication in 2002 . Covers 4 distinct patient populations.
- Other (4)
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Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04005469 | 974570-5 | Ph 1, Ph 2 | recruiting | Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation |
| NCT05564637 results posted | 22-004971 | Ph 2 | completed | A Study of Treprostinil to Treat Interstitial Lung Disease Pulmonary Hypertension |
| NCT07177703 | Tre-ImPAH | Ph 2 | not yet recruiting | Efficacy and Safety of Treprostinil in Intermediate-Risk Pulmonary Arterial Hypertension |
| NCT01481974 | STUDY19100094 | Ph 1 | completed | Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation |
| NCT05067270 results posted | 18278 I8B-MC-ITTC, 2021-001987-18 | Ph 1 | completed | A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus |
| NCT04675944 | BIA-51058-106 2017-000245-43 | Ph 1 | completed | Effect of BIA 5-1058 on the Steady State Pharmacokinetics of Treprostinil |
| NCT02865733 | SJTUMS-201607 | Ph 3 | completed | Study of Remodulin® in Pediatric Pulmonary Hypertension With Single Ventricular Physiology After Fontan Surgery |
| NCT00705133 results posted | 07-11-087-01 | Ph 2 | completed | Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension |
| NCT02769624 results posted | 2015-1491 | Ph 2 | terminated | Acute Effects of Inhaled Treprostinil in Fontan Patients |
| NCT02770521 results posted | 16071 I8B-JE-ITRK | Ph 1 | completed | A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants |
| NCT02847260 RAPID results posted | REM-PH-416 | Ph 4 | completed | Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) |
| NCT01268553 results posted | Tyvaso Switch | Ph 4 | completed | Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication |
| NCT01082484 INFLUX-IT-VS | 2009-016301-42 | Ph 1, Ph 2 | completed | Cutaneous Iontophoresis of Iloprost and Treprostinil in Healthy Volunteers |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REMODULIN FDA Label Details
View full patent landscape →
5 OB patents · 2 families ·
70 international docs across 8 countries
REMODULIN Patents & Exclusivity
Latest Patent: Mar 2029
Patents (5 active)
US7999007
Expires Mar 29, 2029
US9593066
Expires Dec 15, 2028
US11723887
Expires Dec 15, 2028
US8653137
Expires Sep 5, 2028
US8658694
Expires Sep 5, 2028
Source: FDA Orange Book
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Patent Timeline
- • Cliff: 2029
- • 336 active patents
Trial Analysis
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- • Development stage analysis
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- • Competitor tracking
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.