Drugs / Vonicog Alfa
Vonicog Alfa
also known as
BAX 111 · TAK-577 · VEYVONDI · von Willebrand factor (Recombinant) · vonicog alpha · VONVENDI
Protein / enzyme biologic targets VWF
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Veyvondi | — | 2018-08-31 | europa.eu ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 34 trials | ||||||
| Phase 3 | NCT07129343 | Oct 2025 → Nov 2027 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT05582993 | Nov 2024 → Apr 2030 expected | von Willebrand disease (hereditary or acquired) | Takeda | Recruiting | No outcome recorded |
| Phase 3 | NCT02973087 | Nov 2017 → Jul 2020 | von Willebrand disease (hereditary or acquired) | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02932618 | Nov 2017 → Apr 2026 | von Willebrand disease (hereditary or acquired) | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06173024 | — | von Willebrand disease (hereditary or acquired) | Takeda | Available | No outcome recorded |
Press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-05 | Takeda | U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease takeda.com ↗ |
| 2018-09-12 | Takeda | Shire granted EU marketing authorization for VEYVONDI® [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease takeda.com ↗ |
| 2018-07-02 | Takeda | CHMP recommends EU marketing authorization for VEYVONDI® [vonicog alfa, recombinant von Willebrand factor] for adults with von Willebrand disease takeda.com ↗ |
| 2018-05-22 | Takeda | SHIRE RELEASES DATA AT THE WORLD FEDERATION OF HEMOPHILIA CONGRESS 2018 EVALUATING VONVENDI® IN ADULTS WITH VON WILLEBRAND DISEASE DURING AND AFTER SURGERY takeda.com ↗ |
| 2018-04-17 | Takeda | FDA approves VONVENDI® [von Willebrand factor (recombinant)] for perioperative management of bleeding in adult patients with von Willebrand disease[1] takeda.com ↗ |
| 2017-06-22 | Takeda | Shire announces EMA validation of VEYVONDI™ [von Willebrand factor (Recombinant)] Marketing Authorization Application for treatment of von Willebrand disease takeda.com ↗ |
| 2016-12-02 | Takeda | Topline results of Phase 3 investigational study of VONVENDI™ [von Willebrand factor (Recombinant)] meets primary endpoint effectively controlling bleeding and blood loss during surgical procedures takeda.com ↗ |
| 2016-08-09 | Takeda | VONVENDI, THE FIRST AND ONLY RECOMBINANT TREATMENT FOR ADULTS AFFECTED BY VON WILLEBRAND DISEASE, LAUNCHES IN THE U.S. takeda.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vonicog alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02932618 ↗ |
| Known as | BAX 111 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107873 ↗ |
| Known as | TAK-577 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06173024 ↗ |
| Known as | VEYVONDI | “Recently, however, a novel recombinant VWF (rVWF or vonicog alpha, VONVENDI [US], VEYVONDI [Europe]) has arrived to the market for the treatment of VWD.” PMID 36861346 ↗ Mar 2023 |
| Known as | von Willebrand factor (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02973087 ↗ |
| Known as | vonicog alpha | “Recently, however, a novel recombinant VWF (rVWF or vonicog alpha, VONVENDI [US], VEYVONDI [Europe]) has arrived to the market for the treatment of VWD.” PMID 36861346 ↗ Mar 2023 |
| Known as | VONVENDI | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07129343 ↗ |
| Modality | Protein / enzyme biologic | “recombinant von Willebrand factor” NCT02932618 ↗ |
| Route | Intravenous | “OD participants will receive intravenous (IV) rVWF:RCo” NCT02973087 ↗ |
| Target | VWF | “von Willebrand factor exogenous protein” CHEMBL2107873 ↗ |