Drugs / simoctocog alfa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Nuwiq | — | 2014-07-22 | europa.eu ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04592692 | Dec 2019 → Feb 2022 | hemophilia A | Ascension Healthcare Development Limited | Unknown | No outcome recorded |
| Phase 2 | NCT00989196 | May 2010 → Oct 2011 | hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT04030052 | Feb 2022 → Jan 2023 | hemophilia A | Emory University | Withdrawn | No outcome recorded |
| Phase 3 | NCT02256917 | May 2015 → Sep 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01992549 | Apr 2014 → Dec 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01863758 | Aug 2013 → Jan 2015 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01712438 | Feb 2013 → Dec 2018 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 3 | NCT01341912 | Jun 2011 → Aug 2012 | severe hemophilia A | Octapharma | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05936580 | Apr 2026 → Feb 2027 expected | hemophilia A | Octapharma | Recruiting | No outcome recorded |
| Phase 4 | NCT05935358 | Nov 2023 → Aug 2026 overdue | severe hemophilia A | Octapharma | Recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | simoctocog alfa | “Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical...” PMID 41151952 ↗ Oct 20252“Intravenous co-administration of PEGLip with Simoctocog alfa” NCT04592692 ↗ “simoctocog alfa (Nuwiq®), a recombinant factor VIII (FVIII)” PMID 39624518 ↗ Dec 2024 |
| Known as | Human Cell Line-derived Recombinant Factor VIII | “Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII)” NCT01712438 ↗ |
| Known as | Human-cl rhFVIII | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01992549 ↗ |
| Known as | Nuwiq | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04030052 ↗ |
| Known as | Vihuma | ChEMBL registry synonym — accepted as the source's own label CHEMBL2108319 ↗ |
| Action | Restore | “a prophylactic FVIII replacement therapy” NCT04592692 ↗ |
| Modality | Protein / enzyme biologic | “human cell-line derived recombinant FVIII concentrate” NCT00989196 ↗ |
| Route | Intravenous | “administered intravenously” NCT01341912 ↗ |
| Target | F8 | “Coagulation factor VIII exogenous protein” CHEMBL2108319 ↗ |