Drugs / Efepoetin Alfa
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06490939 | Oct 2024 → Mar 2025 | — | Genexine, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06466785 | Jan 2024 → Jun 2027 expected | anemia due to chronic disorder | Genexine, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT04155125 | Jul 2020 → Mar 2022 | anemia due to chronic disorder | PT Kalbe Genexine Biologics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-10-23 | PT Kalbe Farma Tbk | Regulatory KALBE RECEIVES MARKET APPROVAL FOR ANEMIA TREATMENT - EFEPOETIN ALFA BY INDONESIAN MINISTRY OF FOOD AND DRUG SAFETY co.id ↗
Jakarta, 23 October 2023, PT Kalbe Farma Tbk (Kalbe) through its subsidiary Kalbe-Genexine Biologics (KGbio) receives market approval by the Indonesian Ministry of Food and Drug Safety (BPOM for Efepoetin alfa, the first anemia treatment developed and produced in Indonesia-. |
| 2023-10-23 | Genexine, Inc. | Regulatory Genexine and KGbio received the first market approval for novel long-acting Erythropoietin, Efepoetin alfa, from The Indonesian Food and Drug Authority (BPOM) genexine.com ↗
announced the approval of its long-acting erythropoietin, Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anemia in non-dialysis patients. |
| 2023-04-11 | Genexine, Inc. | Results Genexine’s long-acting anemia treatment GX-E4 phase 3 clinical trial interim result is presented at WCN2023, confirmed non-inferiority compared to Mircera. genexine.com ↗
Its non-inferiority results compared to Mircera (Methoxy Polyethylene Glycol-epoetin beta) were presented at the World Congress of Nephrology (WCN2023). |
| 2021-04-05 | PT Kalbe Farma Tbk | Regulatory Kalbe Adds South Korea for Ohase 3 of Clinical Trials of Anemia Medicine Ephepoetin Alpha co.id ↗
With the approval of phase 3 clinical trials in South Korea, the number of countries involved in clinical trials of the drug Efepoetin Alfa (EPO-HyFc, GXE4) will increase to 7 countries including Indonesia, Australia, Taiwan, the Philippines, Thailand and Malaysia. |
All press releases naming this drug 4 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | efepoetin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04155125 ↗ |
| Known as | Efepoetina alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594471 ↗ |
| Known as | Efepoetine alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594471 ↗ |
| Known as | GX-E2 | “Efepoetin alfa (Epoetin-Fc fusion protein, GX-E2 or GX-E4,) is a novel long-acting erythropoietin-hybrid fragment crystallizable (Fc) fusion protein developed by Genexine” NCT06466785 ↗ |
| Known as | GX-E4 | “This study is to objectively evaluate pharmacokinetics as well as pharmacodynamic responses after a single intravenous administration of the Efepoetin alfa, GX-E4, in healthy...” NCT06490939 ↗ |
| Action | Activate | “Erythropoietin receptor agonist” CHEMBL4594471 ↗ |
| Modality | Protein / enzyme biologic | “Efepoetin alfa (Epoetin-Fc fusion protein, GX-E2 or GX-E4,) is a novel long-acting erythropoietin-hybrid fragment crystallizable (Fc) fusion protein developed by Genexine” NCT06466785 ↗ |
| Route | Subcutaneous | “subcutaneous efepoetin alfa” NCT04155125 ↗ |
| Target | EPOR | “Erythropoietin receptor agonist” CHEMBL4594471 ↗ |