Drugs / Damoctocog alfa pegol
Damoctocog alfa pegol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Jivi | — | 2018-11-22 | europa.eu ↗ |
Trials 4 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04015492 | Aug → Oct 2019 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05147662 | Mar 2022 → Jan 2024 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT05036278 | Jul 2022 → Sep 2024 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT04085458 | Sep 2019 → May 2022 | hemophilia A | Bayer | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | damoctocog alfa pegol | “The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding.” NCT05036278 ↗ |
| Known as | BAY94-9027 | “Damoctocog alfa pegol (Jivi, BAY94-9027)” NCT04085458 ↗2“Damoctocog-alfa-pegol (BAY94-9027, Jivi)” NCT04015492 ↗ “Damoctocog alfa pegol (Jivi, BAY94-9027)” NCT05147662 ↗ |
| Known as | Jivi | “Damoctocog alfa pegol (Jivi, BAY94-9027)” NCT04085458 ↗2“Damoctocog-alfa-pegol (BAY94-9027, Jivi)” NCT04015492 ↗ “Damoctocog alfa pegol (Jivi, BAY94-9027)” NCT05147662 ↗ |
| Action | Restore | “It works by replacing the missing FVIII, or the FVIII that does not work properly.” NCT05036278 ↗ |
| Modality | Protein / enzyme biologic | “damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products” PMID 32974838 ↗ Sep 2020 |
| Route | Intravenous | “Both drugs are injected into a vein.” NCT04015492 ↗ |