bivv001
Trade name: Advate
Recombinant proteinexperimental
Clinical trial activity
14 trials · 8 clinical orgs · 0 marketing orgs
Phase 1
5
Phase 2
6
Phase 3
5
Phase 4
4
Earliest trial started Mar 3, 2016 (NCT02716194)
Timeline
Indications
Approved for
Mechanism of action
- Coagulation factor VIIIEXOGENOUS PROTEIN
Coagulation factor VIII exogenous protein
- Coagulation factor VIIISupplementation
F8 supplementation
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5095275 ↗
Also known as
- bax 826
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07158606 | Phase 4 | Oct 1, 2025 | Versiti |
| NCT06941870 | Phase 4 | Sep 23, 2025 | Sanofi |
| NCT06940830 | Phase 4 | May 21, 2025 | PSI CRO, Swedish Orphan Biovitrum |
| NCT06716814 | Phase 3 | Jan 31, 2025 | PSI CRO, Swedish Orphan Biovitrum |
| NCT06752850 | Phase 4 | Dec 19, 2024 | PSI CRO, Swedish Orphan Biovitrum |
| NCT06579144 | Phase 1 | Nov 30, 2024 | PSI CRO, Swedish Orphan Biovitrum |
| NCT05817812 | Phase 3 | Jul 31, 2023 | Swedish Orphan Biovitrum, Syneos Health |
| NCT05042440 | Phase 1 | Aug 11, 2021 | Sanofi |
| NCT04770935 | Phase 1 | May 3, 2021 | Sanofi, Sanofi-Aventis |
| NCT04759131 | Phase 3 | Feb 19, 2021 | Sanofi, Sanofi-Aventis |
| NCT04644575 | Phase 3 | Jan 19, 2021 | Sanofi, Sanofi-Aventis |
| NCT04161495 | Phase 3 | Dec 5, 2019 | Sanofi |
| NCT03205163 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2017 | Bioverativ Therapeutics Inc. |
| NCT02716194 | Phase 1 | Mar 3, 2016 | Baxalta |
Showing 14 of 14 trials
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Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sanofi | For profit | 6 | 3 | 3 | 2019 |
| Swedish Orphan Biovitrum | For profit | 5 | 5 | 3 | 2023 |
| PSI CRO | For profit | 4 | 0 | 3 | 2024 |
| Sanofi-Aventis | For profit | 3 | 3 | 2 | 2021 |
| Baxalta | For profit | 1 | 1 | 1 | 2016 |
| Bioverativ Therapeutics Inc. | For profit | 1 | 1 | 1 | 2017 |
| Syneos Health | For profit | 1 | 0 | 1 | 2023 |
| Versiti | Academic/Hospital | 1 | 1 | 1 | 2025 |
8 organizations
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