Treprostinil
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | TYVASO | — | 2014-05-20 – 2021-03-31 | fda.gov ↗ |
| Approved | EU (EMA) | Trepulmix | — | 2020-04-03 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | REMODULIN | — | 2004-11-24 – 2006-03-20 | fda.gov ↗ |
| Approved | US (FDA) | REMODULIN | — | 2002-05-21 | fda.gov ↗ |
Trials 88 · started per year
Also used as a comparator or background therapy in 12 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02583789 Comparator | May 2016 → Dec 2021 | Raynaud disease | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT06193031 Background | Nov → Dec 2015 | — | Insmed Incorporated | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02178566 Comparator | Aug 2015 → Jan 2019 | chronic obstructive pulmonary disease | Inova Health Care Services | Terminated | No outcome recorded |
| Phase 2 | NCT02261883 Comparator | Jul 2015 → Sep 2022 | pulmonary hypertension, neonatal | United Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT02370095 Comparator | Feb 2015 → Oct 2017 | adult acute respiratory distress syndrome | University of North Carolina, Chapel Hill | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02630316 Comparator | Feb 2017 → Dec 2019 | combined pulmonary fibrosis-emphysema syndrome, interstitial lung disease, pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT02999906 Comparator | Oct 2017 → Dec 2021 | pulmonary arterial hypertension | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT00760916 Comparator | Dec 2008 → Jan 2009 | pulmonary hypertension | United Therapeutics | Withdrawn | No outcome recorded |
| Phase 3 | NCT00325403 Comparator | Oct 2006 → Apr 2011 | pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT00325442 Comparator | Oct 2006 → Sep 2008 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01305252 Comparator | Jul 2010 → Sep 2014 | pulmonary arterial hypertension | Stanford University | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05572996 Background | — | combined pulmonary fibrosis-emphysema syndrome, interstitial lung disease, pulmonary hypertension | Ferrer Internacional S.A. | Available | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | treprostinil | “This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous...” NCT01588405 ↗87“The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release \[SR\] tablets) to...” NCT01477333 ↗ “FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of...” NCT00760916 ↗ “Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo.” NCT00458042 ↗ “Treprostinil diolamine (oral treprostinil) is an orally available prostacyclin analog that was developed for the treatment of pulmonary arterial hypertension.” PMID 24603117 ↗ Mar 2014 “Treprostinil is a stable prostacyclin analog approved for the treatment of pulmonary arterial hypertension (PAH) as parenteral or inhaled therapy.” PMID 23669822 ↗ Sep 2013 “Liposomal Treprostinil Inhalation Suspension (L606)” NCT04691154 ↗ |
| Known as | Inhaled treprostinil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00147199 ↗ |
| Known as | iTRE | “evaluated the safety and efficacy of inhaled treprostinil (iTRE) in this patient population.” PMID 38811045 ↗ Jun 2024 |
| Known as | L606 | “The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose...” NCT04041648 ↗ |
| Known as | LIQ861 | “Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients” NCT03992755 ↗1“inhaled dry powder treprostinil (LIQ861)” NCT03884465 ↗ |
| Known as | Remodulin | “Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo.” NCT00458042 ↗8“Remodulin® (treprostinil sodium), a stable analogue of prostacyclin” NCT00643604 ↗ “Remodulin® (treprostinil sodium) Injection” NCT00060996 ↗ “Remodulin (treprostinil sodium) Injection” NCT00067041 ↗ “Remodulin (treprostinil sodium)” NCT00494533 ↗ |
| Known as | treprostinil diethanolamine | “A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an...” NCT00651885 ↗4“A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma.” NCT00775463 ↗ “Oral UT-15C (Treprostinil Diethanolamine)SR Tablets” NCT00445159 ↗ “UT-15C SR (treprostinil diethanolamine)” NCT01131845 ↗ |
| Known as | treprostinil diolamine | “METHODS: We examined 19 circulating vascular, angiogenic, and inflammatory biomarkers in 124 patients with scleroderma and DU who participated in a randomized controlled trial...” PMID 31858338 ↗ Dec 20191“UT-15C (treprostinil diolamine)” NCT01560637 ↗ |
| Known as | treprostinil sodium | “Generic treprostinil sodium + Standard of Care (Double Oral)” NCT06317805 ↗8“Remodulin® (treprostinil sodium) Injection” NCT00060996 ↗ “Remodulin (treprostinil sodium) Injection” NCT00067041 ↗ “Remodulin (treprostinil sodium)” NCT00494533 ↗ “Drug: Treprostinil sodium” NCT01416636 ↗ |
| Known as | Tyvaso | “Participants will receive inhaled Treprostinil (Tyvaso nebulizer), 6 µg per breath, administered four times daily for 4 weeks.” NCT07037836 ↗ |
| Known as | Tyvaso DPI | “BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension.” PMID 35514770 ↗ Apr 2022 |
| Known as | UT-15 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00004497 ↗ |
| Known as | UT-15C | “A Randomized, Single-Center, Placebo Controlled Study To Assess the Safety of UT-15C (Treprostinil Diethanolamine) Sustained Release (SR) in Patients Undergoing an...” NCT00651885 ↗9“This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have...” NCT01560637 ↗ “A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma.” NCT00775463 ↗ “Oral treprostinil (UT-15C), a synthetic prostacyclin analog that inhibits platelet aggregation, induces vasodilation, and suppresses smooth muscle proliferation.” NCT02583789 ↗ “randomized (1:1 oral treprostinil (UT-15C): placebo)” NCT01560624 ↗ “Oral treprostinil (UT-15C) sustained release tablets” NCT00325442 ↗ “Oral treprostinil (UT-15C) Sustained Release Tablets” NCT00325403 ↗ “Oral treprostinil (UT-15C) sustained release tablets” NCT07112183 ↗ “Oral UT-15C (Treprostinil Diethanolamine)SR Tablets” NCT00445159 ↗ |
| Known as | UT-15C SR | “This study provided/continued to provide oral treprostinil (UT-15C SR; treprostinil diethanolamine) to eligible subjects who participated in Studies TDE-PH-202, TDE-PH-203,...” NCT01027949 ↗2“A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral...” NCT01172496 ↗ “UT-15C SR (treprostinil diethanolamine)” NCT01131845 ↗ |
| Known as | UT-15C sustained release (SR) | “This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous...” NCT01588405 ↗ |
| Modality | Other / unclassified | “a prostacyclin analog” NCT00458042 ↗ |
| Route | Subcutaneous | “continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks” NCT00004497 ↗ |