Drugs / epoprostenol
epoprostenol
also known as
Flolan · ACT-385781A · Actelion Epoprostenol · Epoprostenol Sodium · Prostacyclin · VentaProst · EFI/ACT-385781A · iEPO · +3 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FLOLAN | — | 2000-04-14 | fda.gov ↗ |
| Approved | US (FDA) | FLOLAN | — | 1995-09-20 | fda.gov ↗ |
Trials 12 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials | ||||||
| Phase 2 | NCT04452669 | Sep 2020 → Jun 2021 | COVID-19 | Aerogen Pharma Limited | Completed | No outcome recorded |
| Phase 2 | NCT03122730 | Aug 2017 → Mar 2019 | pulmonary hypertension | Aerogen Pharma Limited | Completed | No outcome recorded |
| Phase 2 | NCT01370096 | Feb 2012 → Sep 2016 | pulmonary hypertension | University of Alberta | Terminated | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01470144 | Jun 2011 → Jun 2015 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 3 | NCT01431716 | Mar 2011 → Feb 2012 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT04231084 | Jan 2021 → Aug 2024 | pulmonary hypertension | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02705807 | May → Jul 2016 | cardiovascular disorder | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02748265 | Mar 2016 → Jul 2017 | — | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT01717209 | Oct 2012 → Oct 2013 | heart failure | Stanford University | Completed | No outcome recorded |
| Phase 4 | NCT01462565 | Nov 2011 → May 2012 | pulmonary arterial hypertension | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01014156 | Jan 2004 → Jun 2006 | pulmonary embolism | University Hospital Brussels | Completed | No outcome recorded |
| Phase 4 | NCT00004754 | Aug 1993 → ? | pulmonary hypertension | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01363583 Comparator | Jan 2002 → Dec 2005 | traumatic brain injury | Umeå University | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05450328 Comparator | Dec 2025 → May 2028 expected | heart failure, postoperative ventricular dysfunction | Montreal Heart Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02251041 Comparator | Sep 2014 → Feb 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 2 | NCT01447095 Comparator | Oct 2011 → Jun 2014 | subarachnoid hemorrhage | Rune Rasmussen | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07424378 Comparator | Feb 2026 → Nov 2028 expected | — | University of Colorado, Denver | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03081052 Comparator | May 2017 → Oct 2020 | — | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01105117 Comparator | May 2010 → Jul 2011 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT01105091 Comparator | Mar 2010 → May 2011 | pulmonary arterial hypertension | Actelion | Completed | No outcome recorded |
| Phase 4 | NCT00890214 Comparator | Sep 2007 → May 2008 | acute kidney injury | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00510172 Comparator | Dec 2006 → Sep 2007 | migraine disorder | Glostrup University Hospital, Copenhagen | Unknown | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2008-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Generic Flolan® For Injection tevapharm.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | epoprostenol | “Investigation of safety and efficacy of the new more thermostable formulation of Flolan (epoprostenol) in Japanese patients with pulmonary arterial hypertension (PAH)-An...” PMID 29608587 ↗ Apr 201818“Inhaled epoprostenol (iEPO) has been introduced worldwide as a cost-saving alternative to iNO without high-grade evidence for this indication.” PMID 34787647 ↗ Jan 2022 “VentaProst (epoprostenol solution for inhalation via custom drug delivery system)” NCT03122730 ↗ “Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH” NCT01447095 ↗ “prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome)” NCT00890214 ↗ “10 ng/kg/min of epoprostenol (stable PGI2)” NCT00510172 ↗ |
| Known as | ACT-385781A | “ACT-385781A (Actelion Epoprostenol)” NCT01105117 ↗ |
| Known as | Actelion Epoprostenol | “ACT-385781A (Actelion Epoprostenol)” NCT01105117 ↗1“ACT-385781A (Actelion Epoprostenol)” NCT01105091 ↗ |
| Known as | EFI/ACT-385781A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01431716 ↗ |
| Known as | Epoprostenol Sodium | “Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by...” PMID 25793960 ↗ Mar 20151“Combined Epoprostenol Sodium & Milrinone” NCT05450328 ↗ |
| Known as | Flolan | “Flolan (epoprostenol sodium) is most commonly prescribed to patients with severe pulmonary arterial hypertension (PAH) owing to the requirement that the drug be delivered by...” PMID 25793960 ↗ Mar 20152“Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion” NCT00004754 ↗ “prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome)” NCT00890214 ↗ |
| Known as | iEPO | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03081052 ↗ |
| Known as | iPGI2 | “Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery...” NCT01717209 ↗ |
| Known as | PGI2 | “There is a growing interest in the intraoperative and intensive care use of inhaled epoprostenol (PGI2) for the treatment of pulmonary hypertension (PHT) and hypoxia of cardiac...” PMID 11606352 ↗ Oct 2001 |
| Known as | Prostacyclin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01717209 ↗ |
| Known as | prostaglandin I2 | “Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion” NCT00004754 ↗ |
| Known as | VentaProst | “VentaProst (epoprostenol solution for inhalation via custom drug delivery system)” NCT03122730 ↗1“VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)” NCT04452669 ↗ |
| Modality | Other / unclassified | “Injectable Prostanoid” NCT01105117 ↗ |
| Route | Other | “by chronic infusion” NCT00004754 ↗ |