Drugs / Efmoroctocog Alfa
Efmoroctocog Alfa
also known as
Eloctate · rFVIIIFc · Efraloctocog alfa · Elocta · ELOCTATE- antihemophilic factor (recombinant), fc fusion protein
Protein / enzyme biologic targets F8
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Elocta | — | 2015-11-18 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03272568 | Feb 2018 → Dec 2019 | hemophilia, menstrual disorder | Emory University | Completed | No outcome recorded |
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT03364998 | Nov 2017 → Jan 2018 | hemophilia A | Bayer | Completed | Met primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT02196207 | Aug 2020 → Jul 2027 | severe hemophilia A | Margaret Ragni | Withdrawn | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04728217 | Apr 2021 → Feb 2023 | hemophilia A | The League of Clinical Research, Russia | Completed | No outcome recorded |
| Phase 4 | NCT03103542 | Aug 2017 → Sep 2019 | hemophilia A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT04303559 Comparator | Oct 2021 → Apr 2022 | hemophilia A | Margaret Ragni | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04690322 Comparator | Apr 2021 → Jul 2027 | hemophilia A | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
Press releases naming this drug 36 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efmoroctocog Alfa | “rescue ITI with efmoroctocog alfa, an extended half-life recombinant FVIII Fc fusion protein (herein rFVIIIFc)” PMID 39583653 ↗ Nov 2024 |
| Known as | Efraloctocog alfa | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297945 ↗ |
| Known as | Elocta | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03364998 ↗ |
| Known as | Eloctate | “Efmoroctocog Alfa Injection [Eloctate]” NCT04728217 ↗ |
| Known as | ELOCTATE- antihemophilic factor (recombinant), fc fusion protein | “ELOCTATE- antihemophilic factor (recombinant), fc fusion protein” NCT04690322 ↗ |
| Known as | rFVIIIFc | “Prevention Trial, Arm A: rFVIIIFc (Eloctate) 65 IU/kg weekly will be administered by intravenous infusion in previously untreated children with severe hemophilia A beginning...” NCT02196207 ↗2“randomized to preemptive weekly Eloctate (rFVIIIFc) vs. weekly Emicizumab (Hemlibra) to prevent inhibitor formation” NCT04303559 ↗ “rescue ITI with efmoroctocog alfa, an extended half-life recombinant FVIII Fc fusion protein (herein rFVIIIFc)” PMID 39583653 ↗ Nov 2024 |
| Action | Restore | “restore the clinical efficacy of factor replacement therapy” PMID 39583653 ↗ Nov 2024 |
| Modality | Protein / enzyme biologic | “an extended half-life recombinant FVIII Fc fusion protein” PMID 39583653 ↗ Nov 2024 |
| Route | Intravenous | “will be administered by intravenous infusion” NCT02196207 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL4297945 ↗ |