Drugs / Eprex
Eprex
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05181735 | May 2022 → Dec 2028 expected | myelodysplastic syndrome | Groupe Francophone des Myelodysplasies | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT02708914 | Mar 2016 → Oct 2021 | anemia | UBI Pharma Inc. | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03572647 Comparator | Nov 2012 | chronic kidney disease | Azidus Brasil | Completed | No outcome recorded |
| Phase 3 | NCT03408639 Comparator | Jun 2016 → Jul 2017 | aregenerative anemia | Cinnagen | Completed | Met primary |
| Phase 3 | NCT02947438 Comparator | Dec 2015 → Oct 2021 | anemia | Shenyang Sunshine Pharmaceutical Co., LTD. | Completed | Met primary |
| Phase 4 | NCT02522975 Comparator | Aug 2015 → Jun 2019 | anemia | Shenyang Sunshine Pharmaceutical Co., LTD. | Terminated | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-05-15 | Pfizer | Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA pfizer.com ↗ |
| 2017-05-25 | Pfizer | FDA Advisory Committee Recommends Approval of Pfizer’s Proposed Biosimilar to Epogen®/Procrit® Across All Indications pfizer.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eprex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03572647 ↗ |
| Known as | epoetin alfa | “BACKGROUND: EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as...” PMID 36451454 ↗ Nov 20221“This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in...” PMID 30253403 ↗ Sep 2018 |
| Known as | ERYPO | “BACKGROUND: EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as...” PMID 36451454 ↗ Nov 2022 |
| Known as | PROCRIT | “BACKGROUND: EPREX®/ERYPO®/PROCRIT® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as...” PMID 36451454 ↗ Nov 2022 |
| Route | Subcutaneous | “Frequency and Dosage:subcutaneously injection once a week for a period of 52 weeks. The initial dose of EPREX® will be 60 IU/kg body weight.” NCT02522975 ↗ |