Drugs / Efmoroctocog Alfa
Efmoroctocog Alfa
also known as
rFVIIIFc · Eloctate · BIIB031 · Efraloctocog alfa · Elocta · Eloctate ITI · ELOCTATE- antihemophilic factor (recombinant), fc fusion protein · Factor VIII, recombinant human with Fc fusion · +3 more
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 14 · a red edge is where a trial was stopped
| 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 13 trials | ||||||
| Phase 1 | NCT03364998 | Nov 2017 → Jan 2018 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT02083965 | Mar → Oct 2014 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01027377 | Dec 2009 → Jul 2010 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06137092 | Jul → Sep 2023 | severe hemophilia A | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 3 | NCT02196207 | Aug 2020 → Jul 2027 | severe hemophilia A | Margaret Ragni | Withdrawn | No outcome recorded |
| Phase 3 | NCT02502149 | Aug 2015 → Apr 2017 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02234323 | Jan 2015 → Sep 2019 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 3 | NCT01458106 | Nov 2012 → Dec 2013 | hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01454739 | Dec 2011 → Oct 2017 | hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01181128 | Nov 2010 → Aug 2012 | severe hemophilia A | Bioverativ Therapeutics Inc. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04728217 | Apr 2021 → Feb 2023 | hemophilia A | The League of Clinical Research, Russia | Completed | No outcome recorded |
| Phase 4 | NCT03093480 | Dec 2017 → May 2020 | hemophilia A | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 4 | NCT03103542 | Aug 2017 → Sep 2019 | hemophilia A | Swedish Orphan Biovitrum | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 32 trials | ||||||
| Phase 3 | NCT04303572 Background | Nov 2021 → Jun 2022 | severe hemophilia A | Margaret Ragni | Terminated | No outcome recorded |
| Phase 3 | NCT04303559 Comparator | Oct 2021 → Apr 2022 | hemophilia A | Margaret Ragni | Terminated | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04690322 Comparator | Apr 2021 → Jul 2027 | hemophilia A | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 21 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 | BIIB031 | “Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia A” NCT01458106 ↗ |
| 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 ITI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04303572 ↗ |
| Known as | ELOCTATE- antihemophilic factor (recombinant), fc fusion protein | “ELOCTATE- antihemophilic factor (recombinant), fc fusion protein” NCT04690322 ↗ |
| Known as | Factor VIII, recombinant human with Fc fusion | “Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)” NCT06137092 ↗ |
| Known as | recombinant factor VIII Fc fusion protein | “Recombinant factor VIII Fc fusion protein for the treatment of severe haemophilia A: Final results from the ASPIRE extension study.” PMID 32227570 ↗ Mar 2020 |
| Known as | Recombinant Human Coagulation Factor VIII Fusion Protein | “An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and...” NCT01454739 ↗ |
| Known as | recombinant human Factor VIII Fc fusion protein | “The primary objective of the study is to evaluate the long-term safety of recombinant human Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A.” NCT01454739 ↗ |
| 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 ↗11“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 | “Prophylactic factor replacement” PMID 25912075 ↗ Apr 2015 |
| Modality | Protein / enzyme biologic | “rFVIIIFc is a recombinant fusion protein composed of a single molecule of FVIII covalently linked to the Fc domain of human IgG(1) to extend circulating rFVIII t(1/2).” PMID 22223821 ↗ Jan 2012 |
| Route | Intravenous | “single high dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single high dose intravenous injection of rFVIIIFc with...” NCT01027377 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL4297945 ↗ |