Drugs / Epeleuton
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05861453 | Jan 2024 → Jan 2026 | sickle cell disease | Afimmune | Completed | No outcome recorded |
| Phase 2 | NCT02941549 | Dec 2016 → Jan 2019 | NAFLD1 | Afimmune | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-02 | Afimmune | Results Afimmune Reports Positive Phase 2 Results for Epeleuton in Sickle Cell Disease, Reducing Vaso-Occlusive Crisis Rate by 57.4% afimmune.com ↗
Afimmune Ltd., a clinical-stage biopharmaceutical company developing treatments for rare diseases, today announced positive results from a Phase 2 trial of oral epeleuton in adults with sickle cell disease (SCD). |
| 2023-09-18 | Afimmune | Regulatory Afimmune’s Epeleuton is granted both FDA Rare Pediatric Disease and Fast Track Designations for the treatment of Sickle Cell Disease afimmune.com ↗
the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease and Fast Track designations to Afimmune’s Epeleuton for the treatment of Sickle Cell Disease (SCD). |
| 2023-06-05 | Afimmune | Results Data Showing Epeleuton Reduces Endothelial Adhesion Of Red Blood Cells From Sickle Cell Disease Patients Will Be Presented At The EHA 2023 Congress afimmune.com ↗
Under physiological flow conditions, Epeleuton decreased adhesion of SCD patient RBCs at clinically relevant concentrations by affecting both the endothelium and RBCs independently. |
| 2023-01-04 | Afimmune | Regulatory Afimmune Confirm Alignment with FDA on Planned Pivotal Trial of Epeleuton in Sickle Cell Disease Patients afimmune.com ↗
Afimmune, a privately held, clinical stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the successful completion and receipt of minutes from its pre-IND Meeting with the US Food and Drug Administration (FDA) with respect to Epeleuton for the treatment of Sickle Cell Disease (SCD). |
| 2022-09-19 | Afimmune | Regulatory Epeleuton receives orphan-drug designation for Sickle Cell Disease from the EMA afimmune.com ↗
Afimmune, a privately held, clinical stage biopharmaceutical company, today announced that the European Medicines Agency (EMA) has granted orphan drug designation to Epeleuton as an investigational treatment for patients suffering from Sickle Cell Disease. |
| 2022-07-19 | Afimmune | Regulatory Epeleuton receives orphan-drug designation for Sickle Cell Disease from the FDA afimmune.com ↗
Afimmune, a privately held, clinical stage biopharmaceutical company, today announced that the Food and Drug Administration (FDA) in the United States (US) has granted orphan drug designation to Epeleuton as an investigational treatment for patients suffering from Sickle Cell Disease. |
| 2022-06-10 | Afimmune | Results Data Showing Epeleuton As A Potential Treatment For Sickle Cell Disease Will Be Presented At The EHA 2022 Congress afimmune.com ↗
The presentation discusses the novel dual therapeutic effects of Epeleuton on factors associated with sickle cell disease and vaso-occlusive risk. |
| 2022-05-13 | Afimmune | Results EPELEUTON, A NOVEL SYNTHETIC SECOND GENERATION W-3 FATTY ACID, PROTECTS HUMANIZED SICKLE CELL MICE AGAINST HYPOXIA/REOXYGENATION ORGAN DAMAGE afimmune.com ↗ |
| 2021-08-26 | Afimmune | Results Afimmune’s Epeleuton shows large decreases in viral load and pathological changes in COVID-19 study afimmune.com ↗
Epeleuton at clinically relevant doses decreased viral load and replication as evidenced by significant and dose-dependent decreases of viral titres and SARS-CoV-2 RNA in throats, nasal turbinates and lungs. |
All press releases naming this drug 10 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epeleuton | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02941549 ↗ |
| Known as | 15-hydroxy eicosapentaenoic acid ethyl ester | “Background Epeleuton is 15-hydroxy eicosapentaenoic acid ethyl ester, a second-generation synthetic n-3 fatty acid derivative of eicosapentaenoic acid.” PMID 32779505 ↗ Aug 2020 |
| Route | Oral | “orally administered Epeleuton capsules” NCT02941549 ↗ |