Drugs / epoprostenol
epoprostenol
also known as
Flolan · ACT-385781A · Actelion Epoprostenol · epoprostenol sodium · prostacyclin · VentaProst · EFI/ACT-385781A · iEPO · +4 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 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07837869 | Oct 2026 → Feb 2028 expected | — | Garrett Keim | Not yet recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| Phase 4 | NCT00004754 | Aug 1993 → ? | pulmonary hypertension | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Comparator or background therapy10 trials | ||||||
| Phase 1 | NCT01363583 Comparator | Jan 2002 → Dec 2005 | traumatic brain injury | Umeå University | Completed | No outcome recorded |
| 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 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 |
| — | NCT00510172 Comparator | Dec 2006 → Sep 2007 | migraine disorder | Glostrup University Hospital, Copenhagen | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-04-03 | Janssen Research & Development, LLC | Results Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal jnj.com ↗
The panel considered parenteral prostacyclin therapy the treatment of choice in IPAH+ and PAH-CTD patients with high-risk hemodynamics irrespective of other clinical factors. |
| 2008-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Generic Flolan® For Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its epoprostenol, the first generic version of GlaxoSmithKline's Flolan® for Injection. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-04-03 | Janssen Research & Development, LLC | Results from Expert Delphi Consensus Survey on Treatment of Pulmonary Arterial Hypertension (PAH) with Oral Prostacyclin Pathway Agents (PPAs) Published in CHEST Journal jnj.com ↗ |
| 2008-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Generic Flolan® For Injection tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 26 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 201819“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)” NCT01105091 ↗1“ACT-385781A (Actelion Epoprostenol)” NCT01105117 ↗ |
| 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 NCT00890214 ↗ |
| Known as | prostaglandin I2 | “Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion” NCT00004754 ↗ |
| Known as | Veletri | “The goal of this clinical trial is to find the safest dose of a medication called epoprostenol (also known as Veletri) when it is given directly into the ECMO circuit and...” NCT07837869 ↗ |
| 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 ↗ |
| Action | Inhibit | “does have a known side effect of decreasing platelet activation.” NCT07837869 ↗ |
| Modality | Other / unclassified | “Injectable Prostanoid” NCT01105117 ↗ |
| Route | Other | “by chronic infusion” NCT00004754 ↗ |