Drugs / Treprostinil diethanolamine
Treprostinil diethanolamine
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ORENITRAM | — | 2016-01-28 – 2019-10-18 | fda.gov ↗ |
| Approved | US (FDA) | ORENITRAM | — | 2013-12-20 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01165476 | Jul → Aug 2010 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01153386 | Jul → Aug 2010 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00963001 | Sep → Nov 2009 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00963027 | Sep → Oct 2009 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04882774 | Apr 2023 → Apr 2025 | pulmonary hypertension | Mardi Gomberg -Maitland MD, MSc | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 31 trial | ||||||
| Phase 3 | NCT01934582 | Aug → Nov 2013 | pulmonary arterial hypertension | United Therapeutics | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT02318758 Comparator | Sep → Oct 2014 | — | United Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT01104870 Comparator | Apr 2010 → Jan 2013 | pulmonary hypertension | United Therapeutics | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Treprostinil diethanolamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01165476 ↗ |
| Known as | Treprostinil Diolamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04882774 ↗ |
| Known as | UT-15C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01104870 ↗ |
| Known as | UT-15C SR | “A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol” NCT01934582 ↗ |
| Known as | UT-15C Sustained Release (SR) | “UT-15C Sustained Release (SR)” NCT01934582 ↗ |
| Route | Oral | “Treprostinil diethanolamine by mouth” NCT00963001 ↗ |